xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05999448</url>
    </required_header>
    <id_info>
      <org_study_id>R01HD105502</org_study_id>
      <nct_id>NCT05999448</nct_id>
    </id_info>
    <brief_title>Promoting the Well Being of Caregivers Via Telehealth</brief_title>
    <acronym>WellCAST</acronym>
    <official_title>Optimizing a Personalized Health Approach for Virtually Treating High-risk Caregivers During COVID-19 and Beyond</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Purdue University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>University of Virginia</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of Oregon</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of Canterbury</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of Missouri-Columbia</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Indiana University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Georgia State University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Purdue University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this clinical trial is to learn which types of telehealth-based treatments best&#xD;
        fit the needs of caregivers of people with rare neurogenetic conditions. The main questions&#xD;
        it plans to answer are:&#xD;
  &#xD;
          -  Which telehealth support programs best meet the needs of rare disorder caregivers?&#xD;
  &#xD;
          -  How can individuals be matched to support programs that are right for them? What aspects&#xD;
             of an individual (e.g., demographics, mental health symptoms, family characteristics,&#xD;
             lifestyle) predict whether treatment will be a good fit?&#xD;
  &#xD;
          -  Does peer-to-peer coaching help improve patients' experiences during telehealth&#xD;
             treatment?&#xD;
  &#xD;
        Participants will be asked to complete a 12-week treatment program, which may include&#xD;
        self-guided resources, individual therapies, group therapies, and/or peer-to-peer coaching.&#xD;
  &#xD;
        Before, during, and after treatment, participants will complete questionnaires to help&#xD;
        researchers understand their experiences, symptoms, and impressions of their support program.&#xD;
        Questionnaires will include both standard forms (administered up to 5 times throughout the&#xD;
        study) and brief &quot;snapshot surveys&quot; that participants complete on their smartphones up to 3&#xD;
        times per day.&#xD;
  &#xD;
        Some participants will be assigned to a waitlist control, which means that they will provide&#xD;
        data while they are not yet completing a support program. These participants will be assigned&#xD;
        to a support program in the next treatment phase.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Project WellCAST (Supporting Wellbeing of Caregivers via Telehealth) is a multi-phase&#xD;
        research study that aims to develop a scalable, personalized health approach for supporting&#xD;
        caregivers of people with rare disorders. Two previous studies by this research team have&#xD;
        piloted individual interventions in subsets of rare disorder caregiving communities to&#xD;
        establish initial feasibility and acceptability. Now in its third phase, Project WellCAST 3.0&#xD;
        aims to generate a scalable, innovative model for personalizing digital treatments to&#xD;
        caregiver needs. This project has two specific aims:&#xD;
  &#xD;
        AIM 1: Develop and optimize a personalized health algorithm to match neurogenetic syndrome&#xD;
        (NGC) caregivers to digital health treatments using a combination of standard clinical tools&#xD;
        and smartphone-based EMA data.&#xD;
  &#xD;
        Extant clinical and EMA data on NGC caregiver response to COVID-19 was used to develop an&#xD;
        initial routing algorithm to match families to treatment type and intensity. This aim will&#xD;
        compare the effectiveness of algorithm-assigned treatment to &quot;treatment as usual,&quot; optimizing&#xD;
        the algorithm across four waves of intervention. Interventions will be brief, evidence-based,&#xD;
        digital health treatments administered by highly supervised clinical trainees, a&#xD;
        cost-efficient model for directly targeting the secondary health effects of COVID-19.&#xD;
  &#xD;
        AIM 2: Test the efficacy of peer-to-peer coaching, deployed by trained NGC caregivers using&#xD;
        an evidence-based motivational interviewing protocol, in enhancing treatment uptake and&#xD;
        clinical outcomes.&#xD;
  &#xD;
        Peer coaches who are also NGC caregivers will be trained to deploy evidence-based&#xD;
        Participation Enhancement Interventions designed to support treatment engagement and reduce&#xD;
        potential barriers. This aim will evaluate the feasibility and effectiveness of this approach&#xD;
        in reducing secondary health effects of COVID-19 by comparing outcomes across participants&#xD;
        who were randomized to complete treatment with and without peer coaches. Peer coaches will&#xD;
        also provide valuable stakeholder input for designing and optimizing the digital treatment&#xD;
        network.&#xD;
  &#xD;
        DETAILED HUMAN SUBJECTS PROCEDURE:&#xD;
  &#xD;
        ENROLLMENT AND CONSENT 1. At the entry of the study, caregivers will be assessed by the study&#xD;
        team to determine eligibility. The caregivers will then consent to baseline collection. A&#xD;
        subset of caregivers will be enrolled at this phase as waitlist controls. Waitlist controls&#xD;
        will complete the same data collection described below, but without any support program.&#xD;
  &#xD;
        BASELINE. The baseline period of the study lasts two weeks. During this time, caregivers will&#xD;
        complete initial study forms and &quot;snapshot surveys,&quot; which are brief questionnaires sent&#xD;
        three times per day via their smartphones.&#xD;
  &#xD;
        ROUTING. After baseline data collection is complete, caregivers will be routed to a support&#xD;
        program. Random number generators will be used to route caregivers to their study arm,&#xD;
        described below.&#xD;
  &#xD;
        Caregivers may opt out of broadly completing either child-focused or self-focused treatments&#xD;
        but may not select their specific treatment modality. As an exception, any Black caregiver in&#xD;
        the study is eligible to add the CICBT group to their assigned support program.&#xD;
  &#xD;
        CONSENT 2 and INTERVENTION. Participants will provide informed consent specific to their&#xD;
        assigned intervention then begin their 12-week support program. Programs are described below.&#xD;
        During intervention, caregivers will be asked to complete study forms to assess how their&#xD;
        characteristics and experiences have changed interventions; forms will be collected at start&#xD;
        of treatment, midpoint, and endpoint. Caregivers will also complete &quot;snapshot surveys&quot;&#xD;
        (3x/day) during this time.&#xD;
  &#xD;
        FOLLOW UP. Two weeks after completing treatment, caregivers will complete follow-up forms and&#xD;
        a 2-week period of &quot;snapshot surveys.&quot;&#xD;
  &#xD;
        ADDITIONAL PROCEDURES:&#xD;
  &#xD;
        This study will occur across four phases. Phases I and II will enroll up to 500 participants&#xD;
        (to yield 400 participants total) who will be randomly assigned to Algorithm (Algorithm 1&#xD;
        versus No Algorithm) and Peer Coaching (Peer Coaching versus No Peer Coaching).&#xD;
  &#xD;
        After Phase II, investigators will convene a &quot;think tank&quot; that will evaluate primary and&#xD;
        secondary endpoints across arms, with the goal of determining how to optimize the algorithm.&#xD;
        Data analyses will be performed by staff who are not involved in clinical operations. Peer&#xD;
        coaches (who are rare disorder caregivers), clinicians, biostatisticians, and scientists will&#xD;
        collaboratively participate in this think tank, with the goal to optimize the algorithm prior&#xD;
        to Phase III.&#xD;
  &#xD;
        Phase III will enroll up to 250 participants (to yield 200) who will receive the optimized&#xD;
        Algorithm 2 and be randomly assigned to Peer Coaching conditions. After Phase III, a second&#xD;
        think tank will be convened to optimize Algorithm 3.&#xD;
  &#xD;
        Phase IV will enroll up to 250 participants (to yield 200) who will receive the optimized&#xD;
        Algorithm 3 and will be randomly assigned to Peer Coaching conditions.&#xD;
  &#xD;
        Final analyses will compare Algorithm 3 to Algorithm 2, Algorithm 1, and Waitlist Controls.&#xD;
  &#xD;
        RIGOR AND REPRODUCIBILITY.&#xD;
  &#xD;
        Algorithms will be uploaded to a secure, locked site prior to each round of study assignment.&#xD;
        Analyses will be preregistered, and all code will be available for replication efforts.&#xD;
        Masking procedures are described elsewhere in this document.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 28, 2023</start_date>
    <completion_date type="Anticipated">December 29, 2025</completion_date>
    <primary_completion_date type="Anticipated">September 8, 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Factorial Assignment</intervention_model>
      <intervention_model_description>For Waves I-II, caregivers are randomly assigned to either (1) route to a treatment using their personalized health data (&quot;Algorithm 1&quot;) OR route to treatment randomly (&quot;No Algorithm&quot;); for Waves III and IV, caregivers are randomly assigned to Algorithm 1 or an optimized Algorithm 2 (Wave III) or Algorithm 2 or an optimized and final Algorithm 3 (Wave IV).&#xD;
  Across Waves I-IV, caregivers are randomly assigned to receive peer coaching (&quot;Peer Coaching&quot;) or to receive check-ins by a staff member unfamiliar with the peer coaching protocol (&quot;No Peer Coaching&quot;).&#xD;
  Across Waves I-III, a subset of caregivers are assigned to a waitlist control that does not include any treatment or peer coaching.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Care Provider, Outcomes Assessor)</masking>
      <masking_description>Care providers will be masked to the status of peer coaching and algorithm assignment. Peer coaches will be masked to the status of algorithm assignment. Data managers and statisticians evaluating study outcomes will be provided de-identified data and will not be involved in treatment-related study operations.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Change from Baseline on DASS-21 Total-Score at End-of-Treatment Survey</measure>
      <time_frame>Baseline and End-of-Treatment (Treatment Week 12)</time_frame>
      <description>The patient-reported Depression, Anxiety, and Stress Scale, 21 Total Score ranges from 0-63; higher scores indicate greater impairment. Change is measured as (Week 12-Baseline), statistically controlling for Baseline levels.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change from Baseline on PSOC Total Score at End-of-Treatment Survey</measure>
      <time_frame>Baseline and End-of-Treatment (Treatment Week 12)</time_frame>
      <description>The patient-reported Parenting Sense of Competence Total Score includes ranges from 17-102; higher scores indicate greater parenting sense of competency. Wording was adapted from the original 1978 measure to be inclusive of caregivers who are not biological parents or mothers. Change is measured as (Week 12-Baseline), statistically controlling for Baseline symptoms.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change from Baseline on PSI-4-SF Total Score at End-of-Treatment Survey</measure>
      <time_frame>Baseline and End-of-Treatment (Treatment Week 12)</time_frame>
      <description>The patient-reported Parenting Stress Index, 4th Edition (PSI-4-SF) Total T-Score ranges from 0-100; higher scores indicate greater stress. Change is measured as (Week 12-Baseline), statistically controlling for Baseline symptoms.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Average PANAS Negative Affect between Baseline and End-of-Treatment</measure>
      <time_frame>Baseline and End-of-Treatment (Treatment Week 12)</time_frame>
      <description>The patient-reported Positive and Negative Affect Scale (10 items) Negative Affect subscale total score ranges from 10-50; higher scores indicate greater negative affect. For each evaluation period, scores will be averaged across week-long patient-reported ecological momentary assessments, which are collected 3 times per day and 7 days per week. Change will be measured as (Week 12-Baseline), statistically controlling for Baseline levels.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Average Momentary Stress between Baseline and End-of-Treatment</measure>
      <time_frame>Baseline and End-of-Treatment (Treatment Week 12)</time_frame>
      <description>The patient-reported momentary stress item ranges from 0-100; higher scores indicate greater stress. For each evaluation period, scores will be averaged across week-long patient-reported ecological momentary assessments, which are collected 3 times per day and 7 days per week. Change will be measured as (Week 12-Baseline), statistically controlling for Baseline levels.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change from Baseline on CGI-S at End-of-Treatment</measure>
      <time_frame>Baseline and End-of-Treatment (Treatment Week 12)</time_frame>
      <description>The Clinical Global Impression-Severity (CGI-S) is rated by the patient's primary clinician on a scale of 1-7, with higher scores indicating greater impairment. Change will be measured as (Week 12-Baseline), statistically controlling for Baseline levels.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Clinical Global Impression-Improvement (CGI-I) at End-of-Treatment</measure>
      <time_frame>End-of-Treatment (single administration at Treatment Week 12)</time_frame>
      <description>The Clinical Global Impression-Improvement (CGI-S) is rated by the patient's primary clinician on a scale of 1-7, with higher scores indicating greater impairment. Change will be measured as (Week 12-Baseline), statistically controlling for Baseline levels.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Peer Coach Fidelity Across Treatment Sessions</measure>
      <time_frame>Calculated at End-of-Treatment (Treatment Week 12)</time_frame>
      <description>Fidelity will be observer-rated by reliable coders to generate a fidelity ratio (0-100%), defined as the proportion of pre-defined critical session components administered to &quot;acceptable&quot; criterion; higher ratios indicate greater fidelity. The total fidelity score for each patient is calculated as the average of completed Baseline, Midpoint, and End-of-Treatment sessions.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Coaching Session Completion</measure>
      <time_frame>Calculated at End-of-Treatment (Treatment Week 12)</time_frame>
      <description>Completion will be reported by project staff and used to generate a completion ratio (0-100%), defined as the proportion of sessions attended; higher ratios indicate greater completion.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Treatment Session Completion</measure>
      <time_frame>Calculated at End-of-Treatment (Treatment Week 12)</time_frame>
      <description>Completion will be reported by clinicians to generate a completion ratio (0-100%), defined as the proportion of sessions attended; higher ratios indicate greater completion. Participants in the self-guided resource condition will self-report completion across 12 weeks of tasks using a log submitted at end of treatment.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Peer Coaching Satisfaction</measure>
      <time_frame>End-of-Treatment (single administration at Treatment Week 12)</time_frame>
      <description>Patient-reported peer coaching satisfaction scores are averaged across a study-specific feedback survey and range from 1-5; higher scores indicate greater satisfaction.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Treatment Satisfaction</measure>
      <time_frame>End-of-Treatment (single administration at Treatment Week 12)</time_frame>
      <description>Patient-reported treatment satisfaction scores are averaged across a study-specific feedback survey and range from 1-5; higher scores indicate greater satisfaction.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Drop Out Status</measure>
      <time_frame>Calculated at End-of-Treatment (Treatment Week 12)</time_frame>
      <description>&quot;Drop out&quot; is defined as discontinuation of treatment after consenting to treatment and attending at least one session, including active discontinuation and patients lost to follow-up. Variable is dummy coded where 0=patient did not drop out, 1=patient dropped out.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Homework Completion</measure>
      <time_frame>Calculated at End-of-Treatment (Treatment Week 12)</time_frame>
      <description>Completion will be reported by clinicians to generate a completion ratio (0-100%), defined as the proportion of assigned session homework completed; higher ratios indicate greater completion. Participants in the self-guided resource condition will self-report completion across 12 weeks of tasks using a log submitted at end of treatment.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change from Baseline on EES-2 Total Score at End-of-Treatment Survey</measure>
      <time_frame>Baseline and End-of-Treatment (Treatment Week 12)</time_frame>
      <description>The patient-reported Emotion Efficacy Scale-2 (Revised) generates a Total Score from 10-50; higher scores indicate greater emotion efficacy. Change is measured as (Week 12-Baseline), statistically controlling for Baseline symptoms.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from Baseline on DERS Total Score at End-of-Treatment Survey</measure>
      <time_frame>Baseline and End-of-Treatment (Treatment Week 12)</time_frame>
      <description>The patient-reported Difficulties in Emotion Regulation Scale (DERS) Total Score includes possible scores that range from 36-180; higher scores indicate greater difficulties in emotion regulation. Change is measured as (Week 12-Baseline), statistically controlling for Baseline symptoms.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from Baseline on CBCL Total Problem Behaviors at End-of-Treatment Survey</measure>
      <time_frame>Baseline and End-of-Treatment (Treatment Week 12)</time_frame>
      <description>The patient-rated Child Behavior Checklist (CBCL 1.5-5), which the patient uses to describe their child's behaviors, yields a Total Problem Behaviors T-Score that ranges from 50-100; higher scores indicate greater child challenging behavior. Change is measured as (Week 12-Baseline), statistically controlling for Baseline symptoms.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from Baseline on CDI-Words and Gestures at End-of-Treatment Survey</measure>
      <time_frame>Baseline and End-of-Treatment (Treatment Week 12)</time_frame>
      <description>The patient-rated Communicative Development Inventory, Words and Gestures Edition (Vocabulary Checklist: Level I), which the patient uses to describe their child's language, yields a yields a total raw score ranging from 0-89; higher scores indicate greater communicative development. Primary outcome will be &quot;understanding&quot; subscale total score. Change is measured as (Week 12-Baseline), statistically controlling for Baseline symptoms.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from Baseline on CSHQ at End-of-Treatment Survey</measure>
      <time_frame>Baseline and End-of-Treatment (Treatment Week 12)</time_frame>
      <description>The patient-rated Children's Sleep Habits Questionnaire, which the patient uses to describe their child's behaviors, yields a total raw score ranging from 33-99; higher scores indicate greater sleep challenges. Change is measured as (Week 12-Baseline), statistically controlling for Baseline symptoms.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from Baseline on Albany Sleep Problems scale at End-of-Treatment Survey</measure>
      <time_frame>Baseline and End-of-Treatment (Treatment Week 12)</time_frame>
      <description>The patient-rated Albany Sleep Problems scale, which the patient uses to describe their child's behaviors, yields a total raw score ranging from 0-164; higher scores indicate greater sleep challenges. Change is measured as (Week 12-Baseline), statistically controlling for Baseline symptoms.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from Baseline on ZBI-7 at End-of-Treatment Survey</measure>
      <time_frame>Baseline and End-of-Treatment (Treatment Week 12)</time_frame>
      <description>The patient-reported Zarit Burden Inventory Short Form (7 item version) generates a Total Score that ranges from 0-49; higher scores indicate greater burden. Change is measured as (Week 12-Baseline), statistically controlling for Baseline symptoms.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from Baseline on ABC-2 at End-of-Treatment Survey</measure>
      <time_frame>Baseline and End-of-Treatment (Treatment Week 12)</time_frame>
      <description>The patient-rated Aberrant Behavior Checklist - 2nd edition, which the patient uses to describe their child's behaviors, yields a total raw score that ranges from 0-174; higher scores indicate greater child challenging behavior. Change is measured as (Week 12-Baseline), statistically controlling for Baseline symptoms.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from Baseline on MIBI at End-of-Treatment Survey</measure>
      <time_frame>Baseline and End-of-Treatment (Treatment Week 12)</time_frame>
      <description>The patient-reported Multidimensional Inventory of Black Identity (MIBI) generates a Total Score that ranges from 0-49; higher scores indicate greater burden. Change is measured as (Week 12-Baseline), statistically controlling for Baseline symptoms.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from Baseline on PCL-5 at End-of-Treatment Survey</measure>
      <time_frame>Baseline and End-of-Treatment (Treatment Week 12)</time_frame>
      <description>The patient-reported PTSD Checklist for DSM-5 (PCL-5) generates a Total Score that ranges from 0-80; higher scores indicate greater burden. Change is measured as (Week 12-Baseline), statistically controlling for Baseline symptoms.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Change in Daily Reports of Health Behaviors between Baseline and End-of-Treatment</measure>
      <time_frame>Baseline and End-of-Treatment (Treatment Week 12)</time_frame>
      <description>Patients report daily on prior day exercise and substance use; these values will be averaged to yield total scores between 0-100%; higher scores indicate greater proportion of days engaged in exercise and substance use, respectively. For each evaluation period, scores will be averaged across week-long data collection period; these items are collected one time per day, 7 days per week. Change will be measured as (Week 12-Baseline), statistically controlling for Baseline levels.</description>
    </other_outcome>
    <other_outcome>
      <measure>Change in Daily Reports of Caregiver Sleep between Baseline and End-of-Treatment</measure>
      <time_frame>Baseline and End-of-Treatment (Treatment Week 12)</time_frame>
      <description>Patients report daily on prior day sleep quality (0-100) and duration (0-24 hours); higher scores indicate greater sleep quality and duration, respectively. These items are collected one time per day, 7 days per week, and will be averaged to create one value per week. Change will be measured as (Week 12-Baseline), statistically controlling for Baseline levels.</description>
    </other_outcome>
    <other_outcome>
      <measure>Change in Momentary Self-Efficacy between Baseline and End-of-Treatment</measure>
      <time_frame>Baseline and End-of-Treatment (Treatment Week 12)</time_frame>
      <description>The patient-reported momentary competency item is a single rating from 0-100, and higher scores indicate greater perceptions that a person can handle their day. For each evaluation period, scores will be averaged across week-long patient-reported ecological momentary assessments, which are collected 3 times per day and 7 days per week. Change will be measured as (Week 12-Baseline), statistically controlling for Baseline levels.</description>
    </other_outcome>
    <other_outcome>
      <measure>Change in Daily Reports of Child Challenging Behaviors between Baseline and End-of-Treatment</measure>
      <time_frame>Baseline and End-of-Treatment (Treatment Week 12)</time_frame>
      <description>The patient-reported challenging behavior items monitor (1) severity (scale 0-100) and (2) frequency (0-4 on Likert scale), where higher scores indicate more challenging behaviors. These items are collected one time per day, 7 days per week, and will be averaged to create one value per week. Change will be measured as (Week 12-Baseline), statistically controlling for Baseline levels.</description>
    </other_outcome>
    <number_of_arms>9</number_of_arms>
    <enrollment type="Anticipated">800</enrollment>
    <condition>Caregivers</condition>
    <condition>Parents</condition>
    <arm_group>
      <arm_group_label>No Algorithm + Participation Enhancement Intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants are randomly assigned to support program without use of a personalized health algorithm AND receive the participation enhancement intervention.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>No Algorithm + No Participation Enhancement Intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants are randomly assigned to support program without use of a personalized health algorithm AND do not receive the participation enhancement intervention.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Algorithm 1 + Participation Enhancement Intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants are assigned to support programs using Algorithm 1 AND receive the participation enhancement intervention.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Algorithm 1 + No Participation Enhancement Intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants are assigned to support programs using Algorithm 1 AND do not receive the participation enhancement intervention.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Algorithm 2 + Participation Enhancement Intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants are assigned to support programs using Algorithm 2 AND receive the participation enhancement intervention.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Algorithm 2 + No Participation Enhancement Intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants are assigned to support programs using Algorithm 2 AND do not receive the participation enhancement intervention.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Algorithm 3 + Participation Enhancement Intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants are assigned to support programs using Algorithm 3 AND receive the participation enhancement intervention.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Algorithm 3 + No Participation Enhancement Intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants are assigned to support programs using Algorithm 3 AND do not receive the participation enhancement intervention.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Waitlist Control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Participants are enrolled in the waitlist control condition, which includes identical data collection procedures to participants enrolled in support programs. Waitlist controls are offered the opportunity to enroll in future cycles.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Acceptance and Commitment Therapy (ACT)</intervention_name>
      <description>ACT will be deployed weekly for 12 weeks on an individual basis via secure Zoom. Treatments will be deployed by supervised graduate student clinicians under the supervision of a licensed psychologist.</description>
      <arm_group_label>Algorithm 1 + No Participation Enhancement Intervention</arm_group_label>
      <arm_group_label>Algorithm 1 + Participation Enhancement Intervention</arm_group_label>
      <arm_group_label>Algorithm 2 + No Participation Enhancement Intervention</arm_group_label>
      <arm_group_label>Algorithm 2 + Participation Enhancement Intervention</arm_group_label>
      <arm_group_label>Algorithm 3 + No Participation Enhancement Intervention</arm_group_label>
      <arm_group_label>Algorithm 3 + Participation Enhancement Intervention</arm_group_label>
      <arm_group_label>No Algorithm + No Participation Enhancement Intervention</arm_group_label>
      <arm_group_label>No Algorithm + Participation Enhancement Intervention</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Culturally Informed Cognitive Behavioral Therapy (CICBT), Individual</intervention_name>
      <description>CICBT-Individual will be deployed weekly for 12 weeks on an individual basis via secure Zoom. Treatments will be deployed by supervised graduate student clinicians under the supervision of a licensed psychologist.</description>
      <arm_group_label>Algorithm 1 + No Participation Enhancement Intervention</arm_group_label>
      <arm_group_label>Algorithm 1 + Participation Enhancement Intervention</arm_group_label>
      <arm_group_label>Algorithm 2 + No Participation Enhancement Intervention</arm_group_label>
      <arm_group_label>Algorithm 2 + Participation Enhancement Intervention</arm_group_label>
      <arm_group_label>Algorithm 3 + No Participation Enhancement Intervention</arm_group_label>
      <arm_group_label>Algorithm 3 + Participation Enhancement Intervention</arm_group_label>
      <arm_group_label>No Algorithm + No Participation Enhancement Intervention</arm_group_label>
      <arm_group_label>No Algorithm + Participation Enhancement Intervention</arm_group_label>
      <other_name>Trauma Focused Cognitive Behavioral Therapy</other_name>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Culturally Informed Cognitive Behavioral Therapy (CICBT), Group</intervention_name>
      <description>CICBT-Group will be deployed weekly for 12 weeks in small groups via secure Zoom. Treatments will be deployed by supervised graduate student clinicians under the supervision of a licensed psychologist.</description>
      <arm_group_label>Algorithm 1 + No Participation Enhancement Intervention</arm_group_label>
      <arm_group_label>Algorithm 1 + Participation Enhancement Intervention</arm_group_label>
      <arm_group_label>Algorithm 2 + No Participation Enhancement Intervention</arm_group_label>
      <arm_group_label>Algorithm 2 + Participation Enhancement Intervention</arm_group_label>
      <arm_group_label>Algorithm 3 + No Participation Enhancement Intervention</arm_group_label>
      <arm_group_label>Algorithm 3 + Participation Enhancement Intervention</arm_group_label>
      <arm_group_label>No Algorithm + No Participation Enhancement Intervention</arm_group_label>
      <arm_group_label>No Algorithm + Participation Enhancement Intervention</arm_group_label>
      <other_name>Trauma Focused Cognitive Behavioral Therapy</other_name>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Dialectical Behavioral Therapy (DBT)</intervention_name>
      <description>DBT will be deployed weekly for 12 weeks in small groups via secure Zoom. Treatments will be deployed by supervised graduate student clinicians under the supervision of a licensed psychologist.</description>
      <arm_group_label>Algorithm 1 + No Participation Enhancement Intervention</arm_group_label>
      <arm_group_label>Algorithm 1 + Participation Enhancement Intervention</arm_group_label>
      <arm_group_label>Algorithm 2 + No Participation Enhancement Intervention</arm_group_label>
      <arm_group_label>Algorithm 2 + Participation Enhancement Intervention</arm_group_label>
      <arm_group_label>Algorithm 3 + No Participation Enhancement Intervention</arm_group_label>
      <arm_group_label>Algorithm 3 + Participation Enhancement Intervention</arm_group_label>
      <arm_group_label>No Algorithm + No Participation Enhancement Intervention</arm_group_label>
      <arm_group_label>No Algorithm + Participation Enhancement Intervention</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Durand Sleep Intervention</intervention_name>
      <description>Durand Sleep Intervention will be deployed weekly for 12 weeks, alternating between individual and group formats, via secure Zoom. Treatments will be deployed by supervised graduate student clinicians under the supervision of a licensed psychologist or behavioral analyst.</description>
      <arm_group_label>Algorithm 1 + No Participation Enhancement Intervention</arm_group_label>
      <arm_group_label>Algorithm 1 + Participation Enhancement Intervention</arm_group_label>
      <arm_group_label>Algorithm 2 + No Participation Enhancement Intervention</arm_group_label>
      <arm_group_label>Algorithm 2 + Participation Enhancement Intervention</arm_group_label>
      <arm_group_label>Algorithm 3 + No Participation Enhancement Intervention</arm_group_label>
      <arm_group_label>Algorithm 3 + Participation Enhancement Intervention</arm_group_label>
      <arm_group_label>No Algorithm + No Participation Enhancement Intervention</arm_group_label>
      <arm_group_label>No Algorithm + Participation Enhancement Intervention</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>RUBI Intervention</intervention_name>
      <description>RUBI will be deployed weekly for 12 weeks in small groups via secure Zoom. Treatments will be deployed by supervised graduate student clinicians under the supervision of a licensed behavioral analyst.</description>
      <arm_group_label>Algorithm 1 + No Participation Enhancement Intervention</arm_group_label>
      <arm_group_label>Algorithm 1 + Participation Enhancement Intervention</arm_group_label>
      <arm_group_label>Algorithm 2 + No Participation Enhancement Intervention</arm_group_label>
      <arm_group_label>Algorithm 2 + Participation Enhancement Intervention</arm_group_label>
      <arm_group_label>Algorithm 3 + No Participation Enhancement Intervention</arm_group_label>
      <arm_group_label>Algorithm 3 + Participation Enhancement Intervention</arm_group_label>
      <arm_group_label>No Algorithm + No Participation Enhancement Intervention</arm_group_label>
      <arm_group_label>No Algorithm + Participation Enhancement Intervention</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Naturalistic Communication Intervention (NCI)</intervention_name>
      <description>NCI will be deployed weekly for 12 weeks on an individual basis via secure Zoom. Treatments will be deployed by supervised graduate student clinicians under the supervision of a licensed behavioral analyst.</description>
      <arm_group_label>Algorithm 1 + No Participation Enhancement Intervention</arm_group_label>
      <arm_group_label>Algorithm 1 + Participation Enhancement Intervention</arm_group_label>
      <arm_group_label>Algorithm 2 + No Participation Enhancement Intervention</arm_group_label>
      <arm_group_label>Algorithm 2 + Participation Enhancement Intervention</arm_group_label>
      <arm_group_label>Algorithm 3 + No Participation Enhancement Intervention</arm_group_label>
      <arm_group_label>Algorithm 3 + Participation Enhancement Intervention</arm_group_label>
      <arm_group_label>No Algorithm + No Participation Enhancement Intervention</arm_group_label>
      <arm_group_label>No Algorithm + Participation Enhancement Intervention</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Self-Guided Resources</intervention_name>
      <description>Participants will be provided a self-guided resource notebook that includes 12 weeks of content that parallels the topics examined in other support programs (child behavior management, child sleep, child communication, caregiver mental health, caregiver health behaviors, community connection)</description>
      <arm_group_label>Algorithm 1 + No Participation Enhancement Intervention</arm_group_label>
      <arm_group_label>Algorithm 1 + Participation Enhancement Intervention</arm_group_label>
      <arm_group_label>Algorithm 2 + No Participation Enhancement Intervention</arm_group_label>
      <arm_group_label>Algorithm 2 + Participation Enhancement Intervention</arm_group_label>
      <arm_group_label>Algorithm 3 + No Participation Enhancement Intervention</arm_group_label>
      <arm_group_label>Algorithm 3 + Participation Enhancement Intervention</arm_group_label>
      <arm_group_label>No Algorithm + No Participation Enhancement Intervention</arm_group_label>
      <arm_group_label>No Algorithm + Participation Enhancement Intervention</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Participation Enhancement Intervention (PEI)</intervention_name>
      <description>A standardized PEI intervention will be conducted by trained peer coaches who are also rare disorder caregivers. Each peer coach will work with their clients to complete a &quot;Change Plan Worksheet&quot; and will complete two booster sessions at midpoint and end of treatment. Coaches will also meet with their clients after follow-up data are complete to support connection back to community resources and patient-specific rare disorder communities.</description>
      <arm_group_label>Algorithm 1 + Participation Enhancement Intervention</arm_group_label>
      <arm_group_label>Algorithm 2 + Participation Enhancement Intervention</arm_group_label>
      <arm_group_label>Algorithm 3 + Participation Enhancement Intervention</arm_group_label>
      <arm_group_label>No Algorithm + Participation Enhancement Intervention</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Caregiver and legal guardian of child age 2-35 with neurogenetic condition&#xD;
  &#xD;
            -  Child's syndrome must (1) have an established genetic cause, (2) affect the brain,&#xD;
               resulting in moderate to severe intellectual disability in the majority of patients&#xD;
  &#xD;
            -  Reside in US&#xD;
  &#xD;
            -  Fluent in English (spoken and written)&#xD;
  &#xD;
            -  Seeking support for caregiver mental health/well-being and/or caregiving needs&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Serious mental illness or active addiction that would be inadequately addressed&#xD;
               through dosage of treatments&#xD;
  &#xD;
            -  Actively in treatment that would be redundant with those offered in the protocol&#xD;
  &#xD;
            -  Child's syndrome is not commonly associated with (1) life expectancy less than 35&#xD;
               years or (2) deterioration of previously gained skills.&#xD;
  &#xD;
          Additional treatment-specific inclusion criteria are embedded in the experimental algorithm&#xD;
          that will be adjusted through Aim 1.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Bridgette Kelleher, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Purdue University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Bridgette L Kelleher, PhD</last_name>
      <phone>18438100238</phone>
      <email>bkelleher@purdue.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Purdue University</name>
        <address>
          <city>West Lafayette</city>
          <state>Indiana</state>
          <zip>47907</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Veronika Vozka, MS</last_name>
        <phone>765-494-6754</phone>
        <email>wellcast@purdue.edu</email>
      </contact>
      <investigator>
        <last_name>Bridgette Kelleher, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 11, 2023</last_update_submitted>
    <last_update_submitted_qc>August 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Purdue University</investigator_affiliation>
      <investigator_full_name>KelleherLab</investigator_full_name>
      <investigator_title>Associate Professor</investigator_title>
    </responsible_party>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>IPD will be shared with other researchers using best-practices in open science.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_info_type>Analytic Code</ipd_info_type>
      <ipd_time_frame>Primary outcome IPD will be shared no later than 12 months after study completion.</ipd_time_frame>
      <ipd_access_criteria>Data access may be requested for eligible studies and qualified researchers for the purpose of addressing specific scientific objectives. A mutually signed Data Use Agreement (non-negotiable contract for data use and sharing) must be in place before accessing requested information. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with only information necessary to address the research objectives under the terms of the data sharing agreement.</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05999448
  org study id: R01HD105502
  nct id: NCT05999448
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to learn which types of telehealth-based treatments best
        fit the needs of caregivers of people with rare neurogenetic conditions. The main questions
        it plans to answer are:
  
          -  Which telehealth support programs best meet the needs of rare disorder caregivers?
  
          -  How can individuals be matched to support programs that are right for them? What aspects
             of an individual (e.g., demographics, mental health symptoms, family characteristics,
             lifestyle) predict whether treatment will be a good fit?
  
          -  Does peer-to-peer coaching help improve patients' experiences during telehealth
             treatment?
  
        Participants will be asked to complete a 12-week treatment program, which may include
        self-guided resources, individual therapies, group therapies, and/or peer-to-peer coaching.
  
        Before, during, and after treatment, participants will complete questionnaires to help
        researchers understand their experiences, symptoms, and impressions of their support program.
        Questionnaires will include both standard forms (administered up to 5 times throughout the
        study) and brief "snapshot surveys" that participants complete on their smartphones up to 3
        times per day.
  
        Some participants will be assigned to a waitlist control, which means that they will provide
        data while they are not yet completing a support program. These participants will be assigned
        to a support program in the next treatment phase.
  Project WellCAST (Supporting Wellbeing of Caregivers via Telehealth) is a multi-phase
        research study that aims to develop a scalable, personalized health approach for supporting
        caregivers of people with rare disorders. Two previous studies by this research team have
        piloted individual interventions in subsets of rare disorder caregiving communities to
        establish initial feasibility and acceptability. Now in its third phase, Project WellCAST 3.0
        aims to generate a scalable, innovative model for personalizing digital treatments to
        caregiver needs. This project has two specific aims:
  
        AIM 1: Develop and optimize a personalized health algorithm to match neurogenetic syndrome
        (NGC) caregivers to digital health treatments using a combination of standard clinical tools
        and smartphone-based EMA data.
  
        Extant clinical and EMA data on NGC caregiver response to COVID-19 was used to develop an
        initial routing algorithm to match families to treatment type and intensity. This aim will
        compare the effectiveness of algorithm-assigned treatment to "treatment as usual," optimizing
        the algorithm across four waves of intervention. Interventions will be brief, evidence-based,
        digital health treatments administered by highly supervised clinical trainees, a
        cost-efficient model for directly targeting the secondary health effects of COVID-19.
  
        AIM 2: Test the efficacy of peer-to-peer coaching, deployed by trained NGC caregivers using
        an evidence-based motivational interviewing protocol, in enhancing treatment uptake and
        clinical outcomes.
  
        Peer coaches who are also NGC caregivers will be trained to deploy evidence-based
        Participation Enhancement Interventions designed to support treatment engagement and reduce
        potential barriers. This aim will evaluate the feasibility and effectiveness of this approach
        in reducing secondary health effects of COVID-19 by comparing outcomes across participants
        who were randomized to complete treatment with and without peer coaches. Peer coaches will
        also provide valuable stakeholder input for designing and optimizing the digital treatment
        network.
  
        DETAILED HUMAN SUBJECTS PROCEDURE:
  
        ENROLLMENT AND CONSENT 1. At the entry of the study, caregivers will be assessed by the study
        team to determine eligibility. The caregivers will then consent to baseline collection. A
        subset of caregivers will be enrolled at this phase as waitlist controls. Waitlist controls
        will complete the same data collection described below, but without any support program.
  
        BASELINE. The baseline period of the study lasts two weeks. During this time, caregivers will
        complete initial study forms and "snapshot surveys," which are brief questionnaires sent
        three times per day via their smartphones.
  
        ROUTING. After baseline data collection is complete, caregivers will be routed to a support
        program. Random number generators will be used to route caregivers to their study arm,
        described below.
  
        Caregivers may opt out of broadly completing either child-focused or self-focused treatments
        but may not select their specific treatment modality. As an exception, any Black caregiver in
        the study is eligible to add the CICBT group to their assigned support program.
  
        CONSENT 2 and INTERVENTION. Participants will provide informed consent specific to their
        assigned intervention then begin their 12-week support program. Programs are described below.
        During intervention, caregivers will be asked to complete study forms to assess how their
        characteristics and experiences have changed interventions; forms will be collected at start
        of treatment, midpoint, and endpoint. Caregivers will also complete "snapshot surveys"
        (3x/day) during this time.
  
        FOLLOW UP. Two weeks after completing treatment, caregivers will complete follow-up forms and
        a 2-week period of "snapshot surveys."
  
        ADDITIONAL PROCEDURES:
  
        This study will occur across four phases. Phases I and II will enroll up to 500 participants
        (to yield 400 participants total) who will be randomly assigned to Algorithm (Algorithm 1
        versus No Algorithm) and Peer Coaching (Peer Coaching versus No Peer Coaching).
  
        After Phase II, investigators will convene a "think tank" that will evaluate primary and
        secondary endpoints across arms, with the goal of determining how to optimize the algorithm.
        Data analyses will be performed by staff who are not involved in clinical operations. Peer
        coaches (who are rare disorder caregivers), clinicians, biostatisticians, and scientists will
        collaboratively participate in this think tank, with the goal to optimize the algorithm prior
        to Phase III.
  
        Phase III will enroll up to 250 participants (to yield 200) who will receive the optimized
        Algorithm 2 and be randomly assigned to Peer Coaching conditions. After Phase III, a second
        think tank will be convened to optimize Algorithm 3.
  
        Phase IV will enroll up to 250 participants (to yield 200) who will receive the optimized
        Algorithm 3 and will be randomly assigned to Peer Coaching conditions.
  
        Final analyses will compare Algorithm 3 to Algorithm 2, Algorithm 1, and Waitlist Controls.
  
        RIGOR AND REPRODUCIBILITY.
  
        Algorithms will be uploaded to a secure, locked site prior to each round of study assignment.
        Analyses will be preregistered, and all code will be available for replication efforts.
        Masking procedures are described elsewhere in this document.
  allocation: Randomized
  intervention model: Factorial Assignment
  intervention model description: For Waves I-II, caregivers are randomly assigned to either (1) route to a treatment using their personalized health data ("Algorithm 1") OR route to treatment randomly ("No Algorithm"); for Waves III and IV, caregivers are randomly assigned to Algorithm 1 or an optimized Algorithm 2 (Wave III) or Algorithm 2 or an optimized and final Algorithm 3 (Wave IV).
  Across Waves I-IV, caregivers are randomly assigned to receive peer coaching ("Peer Coaching") or to receive check-ins by a staff member unfamiliar with the peer coaching protocol ("No Peer Coaching").
  Across Waves I-III, a subset of caregivers are assigned to a waitlist control that does not include any treatment or peer coaching.
  primary purpose: Treatment
  masking: Double (Care Provider, Outcomes Assessor)
  masking description: Care providers will be masked to the status of peer coaching and algorithm assignment. Peer coaches will be masked to the status of algorithm assignment. Data managers and statisticians evaluating study outcomes will be provided de-identified data and will not be involved in treatment-related study operations.
  measure: Change from Baseline on DASS-21 Total-Score at End-of-Treatment Survey
  time frame: Baseline and End-of-Treatment (Treatment Week 12)
  description: The patient-reported Depression, Anxiety, and Stress Scale, 21 Total Score ranges from 0-63; higher scores indicate greater impairment. Change is measured as (Week 12-Baseline), statistically controlling for Baseline levels.
  measure: Change from Baseline on PSOC Total Score at End-of-Treatment Survey
  time frame: Baseline and End-of-Treatment (Treatment Week 12)
  description: The patient-reported Parenting Sense of Competence Total Score includes ranges from 17-102; higher scores indicate greater parenting sense of competency. Wording was adapted from the original 1978 measure to be inclusive of caregivers who are not biological parents or mothers. Change is measured as (Week 12-Baseline), statistically controlling for Baseline symptoms.
  measure: Change from Baseline on PSI-4-SF Total Score at End-of-Treatment Survey
  time frame: Baseline and End-of-Treatment (Treatment Week 12)
  description: The patient-reported Parenting Stress Index, 4th Edition (PSI-4-SF) Total T-Score ranges from 0-100; higher scores indicate greater stress. Change is measured as (Week 12-Baseline), statistically controlling for Baseline symptoms.
  measure: Change in Average PANAS Negative Affect between Baseline and End-of-Treatment
  time frame: Baseline and End-of-Treatment (Treatment Week 12)
  description: The patient-reported Positive and Negative Affect Scale (10 items) Negative Affect subscale total score ranges from 10-50; higher scores indicate greater negative affect. For each evaluation period, scores will be averaged across week-long patient-reported ecological momentary assessments, which are collected 3 times per day and 7 days per week. Change will be measured as (Week 12-Baseline), statistically controlling for Baseline levels.
  measure: Change in Average Momentary Stress between Baseline and End-of-Treatment
  time frame: Baseline and End-of-Treatment (Treatment Week 12)
  description: The patient-reported momentary stress item ranges from 0-100; higher scores indicate greater stress. For each evaluation period, scores will be averaged across week-long patient-reported ecological momentary assessments, which are collected 3 times per day and 7 days per week. Change will be measured as (Week 12-Baseline), statistically controlling for Baseline levels.
  measure: Change from Baseline on CGI-S at End-of-Treatment
  time frame: Baseline and End-of-Treatment (Treatment Week 12)
  description: The Clinical Global Impression-Severity (CGI-S) is rated by the patient's primary clinician on a scale of 1-7, with higher scores indicating greater impairment. Change will be measured as (Week 12-Baseline), statistically controlling for Baseline levels.
  measure: Clinical Global Impression-Improvement (CGI-I) at End-of-Treatment
  time frame: End-of-Treatment (single administration at Treatment Week 12)
  description: The Clinical Global Impression-Improvement (CGI-S) is rated by the patient's primary clinician on a scale of 1-7, with higher scores indicating greater impairment. Change will be measured as (Week 12-Baseline), statistically controlling for Baseline levels.
  measure: Peer Coach Fidelity Across Treatment Sessions
  time frame: Calculated at End-of-Treatment (Treatment Week 12)
  description: Fidelity will be observer-rated by reliable coders to generate a fidelity ratio (0-100%), defined as the proportion of pre-defined critical session components administered to "acceptable" criterion; higher ratios indicate greater fidelity. The total fidelity score for each patient is calculated as the average of completed Baseline, Midpoint, and End-of-Treatment sessions.
  measure: Coaching Session Completion
  time frame: Calculated at End-of-Treatment (Treatment Week 12)
  description: Completion will be reported by project staff and used to generate a completion ratio (0-100%), defined as the proportion of sessions attended; higher ratios indicate greater completion.
  measure: Treatment Session Completion
  time frame: Calculated at End-of-Treatment (Treatment Week 12)
  description: Completion will be reported by clinicians to generate a completion ratio (0-100%), defined as the proportion of sessions attended; higher ratios indicate greater completion. Participants in the self-guided resource condition will self-report completion across 12 weeks of tasks using a log submitted at end of treatment.
  measure: Peer Coaching Satisfaction
  time frame: End-of-Treatment (single administration at Treatment Week 12)
  description: Patient-reported peer coaching satisfaction scores are averaged across a study-specific feedback survey and range from 1-5; higher scores indicate greater satisfaction.
  measure: Treatment Satisfaction
  time frame: End-of-Treatment (single administration at Treatment Week 12)
  description: Patient-reported treatment satisfaction scores are averaged across a study-specific feedback survey and range from 1-5; higher scores indicate greater satisfaction.
  measure: Drop Out Status
  time frame: Calculated at End-of-Treatment (Treatment Week 12)
  description: "Drop out" is defined as discontinuation of treatment after consenting to treatment and attending at least one session, including active discontinuation and patients lost to follow-up. Variable is dummy coded where 0=patient did not drop out, 1=patient dropped out.
  measure: Homework Completion
  time frame: Calculated at End-of-Treatment (Treatment Week 12)
  description: Completion will be reported by clinicians to generate a completion ratio (0-100%), defined as the proportion of assigned session homework completed; higher ratios indicate greater completion. Participants in the self-guided resource condition will self-report completion across 12 weeks of tasks using a log submitted at end of treatment.
  measure: Change from Baseline on EES-2 Total Score at End-of-Treatment Survey
  time frame: Baseline and End-of-Treatment (Treatment Week 12)
  description: The patient-reported Emotion Efficacy Scale-2 (Revised) generates a Total Score from 10-50; higher scores indicate greater emotion efficacy. Change is measured as (Week 12-Baseline), statistically controlling for Baseline symptoms.
  measure: Change from Baseline on DERS Total Score at End-of-Treatment Survey
  time frame: Baseline and End-of-Treatment (Treatment Week 12)
  description: The patient-reported Difficulties in Emotion Regulation Scale (DERS) Total Score includes possible scores that range from 36-180; higher scores indicate greater difficulties in emotion regulation. Change is measured as (Week 12-Baseline), statistically controlling for Baseline symptoms.
  measure: Change from Baseline on CBCL Total Problem Behaviors at End-of-Treatment Survey
  time frame: Baseline and End-of-Treatment (Treatment Week 12)
  description: The patient-rated Child Behavior Checklist (CBCL 1.5-5), which the patient uses to describe their child's behaviors, yields a Total Problem Behaviors T-Score that ranges from 50-100; higher scores indicate greater child challenging behavior. Change is measured as (Week 12-Baseline), statistically controlling for Baseline symptoms.
  measure: Change from Baseline on CDI-Words and Gestures at End-of-Treatment Survey
  time frame: Baseline and End-of-Treatment (Treatment Week 12)
  description: The patient-rated Communicative Development Inventory, Words and Gestures Edition (Vocabulary Checklist: Level I), which the patient uses to describe their child's language, yields a yields a total raw score ranging from 0-89; higher scores indicate greater communicative development. Primary outcome will be "understanding" subscale total score. Change is measured as (Week 12-Baseline), statistically controlling for Baseline symptoms.
  measure: Change from Baseline on CSHQ at End-of-Treatment Survey
  time frame: Baseline and End-of-Treatment (Treatment Week 12)
  description: The patient-rated Children's Sleep Habits Questionnaire, which the patient uses to describe their child's behaviors, yields a total raw score ranging from 33-99; higher scores indicate greater sleep challenges. Change is measured as (Week 12-Baseline), statistically controlling for Baseline symptoms.
  measure: Change from Baseline on Albany Sleep Problems scale at End-of-Treatment Survey
  time frame: Baseline and End-of-Treatment (Treatment Week 12)
  description: The patient-rated Albany Sleep Problems scale, which the patient uses to describe their child's behaviors, yields a total raw score ranging from 0-164; higher scores indicate greater sleep challenges. Change is measured as (Week 12-Baseline), statistically controlling for Baseline symptoms.
  measure: Change from Baseline on ZBI-7 at End-of-Treatment Survey
  time frame: Baseline and End-of-Treatment (Treatment Week 12)
  description: The patient-reported Zarit Burden Inventory Short Form (7 item version) generates a Total Score that ranges from 0-49; higher scores indicate greater burden. Change is measured as (Week 12-Baseline), statistically controlling for Baseline symptoms.
  measure: Change from Baseline on ABC-2 at End-of-Treatment Survey
  time frame: Baseline and End-of-Treatment (Treatment Week 12)
  description: The patient-rated Aberrant Behavior Checklist - 2nd edition, which the patient uses to describe their child's behaviors, yields a total raw score that ranges from 0-174; higher scores indicate greater child challenging behavior. Change is measured as (Week 12-Baseline), statistically controlling for Baseline symptoms.
  measure: Change from Baseline on MIBI at End-of-Treatment Survey
  time frame: Baseline and End-of-Treatment (Treatment Week 12)
  description: The patient-reported Multidimensional Inventory of Black Identity (MIBI) generates a Total Score that ranges from 0-49; higher scores indicate greater burden. Change is measured as (Week 12-Baseline), statistically controlling for Baseline symptoms.
  measure: Change from Baseline on PCL-5 at End-of-Treatment Survey
  time frame: Baseline and End-of-Treatment (Treatment Week 12)
  description: The patient-reported PTSD Checklist for DSM-5 (PCL-5) generates a Total Score that ranges from 0-80; higher scores indicate greater burden. Change is measured as (Week 12-Baseline), statistically controlling for Baseline symptoms.
  measure: Change in Daily Reports of Health Behaviors between Baseline and End-of-Treatment
  time frame: Baseline and End-of-Treatment (Treatment Week 12)
  description: Patients report daily on prior day exercise and substance use; these values will be averaged to yield total scores between 0-100%; higher scores indicate greater proportion of days engaged in exercise and substance use, respectively. For each evaluation period, scores will be averaged across week-long data collection period; these items are collected one time per day, 7 days per week. Change will be measured as (Week 12-Baseline), statistically controlling for Baseline levels.
  measure: Change in Daily Reports of Caregiver Sleep between Baseline and End-of-Treatment
  time frame: Baseline and End-of-Treatment (Treatment Week 12)
  description: Patients report daily on prior day sleep quality (0-100) and duration (0-24 hours); higher scores indicate greater sleep quality and duration, respectively. These items are collected one time per day, 7 days per week, and will be averaged to create one value per week. Change will be measured as (Week 12-Baseline), statistically controlling for Baseline levels.
  measure: Change in Momentary Self-Efficacy between Baseline and End-of-Treatment
  time frame: Baseline and End-of-Treatment (Treatment Week 12)
  description: The patient-reported momentary competency item is a single rating from 0-100, and higher scores indicate greater perceptions that a person can handle their day. For each evaluation period, scores will be averaged across week-long patient-reported ecological momentary assessments, which are collected 3 times per day and 7 days per week. Change will be measured as (Week 12-Baseline), statistically controlling for Baseline levels.
  measure: Change in Daily Reports of Child Challenging Behaviors between Baseline and End-of-Treatment
  time frame: Baseline and End-of-Treatment (Treatment Week 12)
  description: The patient-reported challenging behavior items monitor (1) severity (scale 0-100) and (2) frequency (0-4 on Likert scale), where higher scores indicate more challenging behaviors. These items are collected one time per day, 7 days per week, and will be averaged to create one value per week. Change will be measured as (Week 12-Baseline), statistically controlling for Baseline levels.
  arm group label: No Algorithm + Participation Enhancement Intervention
  arm group type: Experimental
  description: Participants are randomly assigned to support program without use of a personalized health algorithm AND receive the participation enhancement intervention.
  arm group label: No Algorithm + No Participation Enhancement Intervention
  arm group type: Experimental
  description: Participants are randomly assigned to support program without use of a personalized health algorithm AND do not receive the participation enhancement intervention.
  arm group label: Algorithm 1 + Participation Enhancement Intervention
  arm group type: Experimental
  description: Participants are assigned to support programs using Algorithm 1 AND receive the participation enhancement intervention.
  arm group label: Algorithm 1 + No Participation Enhancement Intervention
  arm group type: Experimental
  description: Participants are assigned to support programs using Algorithm 1 AND do not receive the participation enhancement intervention.
  arm group label: Algorithm 2 + Participation Enhancement Intervention
  arm group type: Experimental
  description: Participants are assigned to support programs using Algorithm 2 AND receive the participation enhancement intervention.
  arm group label: Algorithm 2 + No Participation Enhancement Intervention
  arm group type: Experimental
  description: Participants are assigned to support programs using Algorithm 2 AND do not receive the participation enhancement intervention.
  arm group label: Algorithm 3 + Participation Enhancement Intervention
  arm group type: Experimental
  description: Participants are assigned to support programs using Algorithm 3 AND receive the participation enhancement intervention.
  arm group label: Algorithm 3 + No Participation Enhancement Intervention
  arm group type: Experimental
  description: Participants are assigned to support programs using Algorithm 3 AND do not receive the participation enhancement intervention.
  arm group label: Waitlist Control
  arm group type: No Intervention
  description: Participants are enrolled in the waitlist control condition, which includes identical data collection procedures to participants enrolled in support programs. Waitlist controls are offered the opportunity to enroll in future cycles.
  intervention type: Behavioral
  intervention name: Acceptance and Commitment Therapy (ACT)
  description: ACT will be deployed weekly for 12 weeks on an individual basis via secure Zoom. Treatments will be deployed by supervised graduate student clinicians under the supervision of a licensed psychologist.
  arm group label: Algorithm 1 + No Participation Enhancement Intervention
  arm group label: Algorithm 1 + Participation Enhancement Intervention
  arm group label: Algorithm 2 + No Participation Enhancement Intervention
  arm group label: Algorithm 2 + Participation Enhancement Intervention
  arm group label: Algorithm 3 + No Participation Enhancement Intervention
  arm group label: Algorithm 3 + Participation Enhancement Intervention
  arm group label: No Algorithm + No Participation Enhancement Intervention
  arm group label: No Algorithm + Participation Enhancement Intervention
  intervention type: Behavioral
  intervention name: Culturally Informed Cognitive Behavioral Therapy (CICBT), Individual
  description: CICBT-Individual will be deployed weekly for 12 weeks on an individual basis via secure Zoom. Treatments will be deployed by supervised graduate student clinicians under the supervision of a licensed psychologist.
  arm group label: Algorithm 1 + No Participation Enhancement Intervention
  arm group label: Algorithm 1 + Participation Enhancement Intervention
  arm group label: Algorithm 2 + No Participation Enhancement Intervention
  arm group label: Algorithm 2 + Participation Enhancement Intervention
  arm group label: Algorithm 3 + No Participation Enhancement Intervention
  arm group label: Algorithm 3 + Participation Enhancement Intervention
  arm group label: No Algorithm + No Participation Enhancement Intervention
  arm group label: No Algorithm + Participation Enhancement Intervention
  other name: Trauma Focused Cognitive Behavioral Therapy
  intervention type: Behavioral
  intervention name: Culturally Informed Cognitive Behavioral Therapy (CICBT), Group
  description: CICBT-Group will be deployed weekly for 12 weeks in small groups via secure Zoom. Treatments will be deployed by supervised graduate student clinicians under the supervision of a licensed psychologist.
  arm group label: Algorithm 1 + No Participation Enhancement Intervention
  arm group label: Algorithm 1 + Participation Enhancement Intervention
  arm group label: Algorithm 2 + No Participation Enhancement Intervention
  arm group label: Algorithm 2 + Participation Enhancement Intervention
  arm group label: Algorithm 3 + No Participation Enhancement Intervention
  arm group label: Algorithm 3 + Participation Enhancement Intervention
  arm group label: No Algorithm + No Participation Enhancement Intervention
  arm group label: No Algorithm + Participation Enhancement Intervention
  other name: Trauma Focused Cognitive Behavioral Therapy
  intervention type: Behavioral
  intervention name: Dialectical Behavioral Therapy (DBT)
  description: DBT will be deployed weekly for 12 weeks in small groups via secure Zoom. Treatments will be deployed by supervised graduate student clinicians under the supervision of a licensed psychologist.
  arm group label: Algorithm 1 + No Participation Enhancement Intervention
  arm group label: Algorithm 1 + Participation Enhancement Intervention
  arm group label: Algorithm 2 + No Participation Enhancement Intervention
  arm group label: Algorithm 2 + Participation Enhancement Intervention
  arm group label: Algorithm 3 + No Participation Enhancement Intervention
  arm group label: Algorithm 3 + Participation Enhancement Intervention
  arm group label: No Algorithm + No Participation Enhancement Intervention
  arm group label: No Algorithm + Participation Enhancement Intervention
  intervention type: Behavioral
  intervention name: Durand Sleep Intervention
  description: Durand Sleep Intervention will be deployed weekly for 12 weeks, alternating between individual and group formats, via secure Zoom. Treatments will be deployed by supervised graduate student clinicians under the supervision of a licensed psychologist or behavioral analyst.
  arm group label: Algorithm 1 + No Participation Enhancement Intervention
  arm group label: Algorithm 1 + Participation Enhancement Intervention
  arm group label: Algorithm 2 + No Participation Enhancement Intervention
  arm group label: Algorithm 2 + Participation Enhancement Intervention
  arm group label: Algorithm 3 + No Participation Enhancement Intervention
  arm group label: Algorithm 3 + Participation Enhancement Intervention
  arm group label: No Algorithm + No Participation Enhancement Intervention
  arm group label: No Algorithm + Participation Enhancement Intervention
  intervention type: Behavioral
  intervention name: RUBI Intervention
  description: RUBI will be deployed weekly for 12 weeks in small groups via secure Zoom. Treatments will be deployed by supervised graduate student clinicians under the supervision of a licensed behavioral analyst.
  arm group label: Algorithm 1 + No Participation Enhancement Intervention
  arm group label: Algorithm 1 + Participation Enhancement Intervention
  arm group label: Algorithm 2 + No Participation Enhancement Intervention
  arm group label: Algorithm 2 + Participation Enhancement Intervention
  arm group label: Algorithm 3 + No Participation Enhancement Intervention
  arm group label: Algorithm 3 + Participation Enhancement Intervention
  arm group label: No Algorithm + No Participation Enhancement Intervention
  arm group label: No Algorithm + Participation Enhancement Intervention
  intervention type: Behavioral
  intervention name: Naturalistic Communication Intervention (NCI)
  description: NCI will be deployed weekly for 12 weeks on an individual basis via secure Zoom. Treatments will be deployed by supervised graduate student clinicians under the supervision of a licensed behavioral analyst.
  arm group label: Algorithm 1 + No Participation Enhancement Intervention
  arm group label: Algorithm 1 + Participation Enhancement Intervention
  arm group label: Algorithm 2 + No Participation Enhancement Intervention
  arm group label: Algorithm 2 + Participation Enhancement Intervention
  arm group label: Algorithm 3 + No Participation Enhancement Intervention
  arm group label: Algorithm 3 + Participation Enhancement Intervention
  arm group label: No Algorithm + No Participation Enhancement Intervention
  arm group label: No Algorithm + Participation Enhancement Intervention
  intervention type: Behavioral
  intervention name: Self-Guided Resources
  description: Participants will be provided a self-guided resource notebook that includes 12 weeks of content that parallels the topics examined in other support programs (child behavior management, child sleep, child communication, caregiver mental health, caregiver health behaviors, community connection)
  arm group label: Algorithm 1 + No Participation Enhancement Intervention
  arm group label: Algorithm 1 + Participation Enhancement Intervention
  arm group label: Algorithm 2 + No Participation Enhancement Intervention
  arm group label: Algorithm 2 + Participation Enhancement Intervention
  arm group label: Algorithm 3 + No Participation Enhancement Intervention
  arm group label: Algorithm 3 + Participation Enhancement Intervention
  arm group label: No Algorithm + No Participation Enhancement Intervention
  arm group label: No Algorithm + Participation Enhancement Intervention
  intervention type: Behavioral
  intervention name: Participation Enhancement Intervention (PEI)
  description: A standardized PEI intervention will be conducted by trained peer coaches who are also rare disorder caregivers. Each peer coach will work with their clients to complete a "Change Plan Worksheet" and will complete two booster sessions at midpoint and end of treatment. Coaches will also meet with their clients after follow-up data are complete to support connection back to community resources and patient-specific rare disorder communities.
  arm group label: Algorithm 1 + Participation Enhancement Intervention
  arm group label: Algorithm 2 + Participation Enhancement Intervention
  arm group label: Algorithm 3 + Participation Enhancement Intervention
  arm group label: No Algorithm + Participation Enhancement Intervention
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Bridgette Kelleher, PhD
  role: Principal Investigator
  affiliation: Purdue University
  last name: Bridgette L Kelleher, PhD
  phone: 18438100238
  email: bkelleher@purdue.edu
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Purdue University
  investigator full name: KelleherLab
  investigator title: Associate Professor
  sharing ipd: Yes
  ipd description: IPD will be shared with other researchers using best-practices in open science.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd info type: Clinical Study Report (CSR)
  ipd info type: Analytic Code
  ipd time frame: Primary outcome IPD will be shared no later than 12 months after study completion.
  ipd access criteria: Data access may be requested for eligible studies and qualified researchers for the purpose of addressing specific scientific objectives. A mutually signed Data Use Agreement (non-negotiable contract for data use and sharing) must be in place before accessing requested information. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with only information necessary to address the research objectives under the terms of the data sharing agreement.