<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/NCT04445155</url>
  </required_header>
  <id_info>
    <org_study_id>1911897011</org_study_id>
    <secondary_id>5R21MD015150-02</secondary_id>
    <nct_id>NCT04445155</nct_id>
  </id_info>
  <brief_title>The DECIDE Parent-Provider Intervention</brief_title>
  <official_title>Modification and Evaluation of the DECIDE Intervention to Improve Parent-provider Interactions in Low-income Parents of Adolescents With Disruptive Impulse Control, and Conduct Disorder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Indiana University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Smith College</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of South Florida</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute on Minority Health and Health Disparities (NIMHD)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Indiana 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 DECIDE Parent-Provider Intervention is designed to support parents caring for adolescents&#xD;
      who are receiving treatment for Disruptive, Impulse-Control, and Conduct disorders.&#xD;
      Participating in DECIDE study may help you effectively ask questions and participate in&#xD;
      decisions about your adolescent's care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Interventions to optimize parent-provider interactions are urgently needed to ensure&#xD;
      adolescents aged 3 to 17 years with Disruptive, Impulse-Control, and Conduct disorders (DIC)&#xD;
      receive the behavioral health care they need. For these adolescents, behavioral health care&#xD;
      is complex, long-term, and requires parental participation. Research shows providers have&#xD;
      biases and limited skills and confidence to communicate with these parents to encourage them&#xD;
      to voice their concerns and care preferences. Low income and minority parents are at greatest&#xD;
      risk of not being involved in their adolescents' behavioral health care, having poor&#xD;
      interactions with providers, and are more likely to perceive poor quality of their&#xD;
      adolescents' behavioral health care, and low treatment engagement. If unaddressed, poor&#xD;
      parent-provider interactions interfere with adolescents' retention in behavioral health care.&#xD;
&#xD;
      No evidence-based interventions have targeted both parents and providers to optimize their&#xD;
      interactions and improve behavioral health care for adolescents with DIC. To address these&#xD;
      problems, the investigators propose modifying the evidence-based DECIDE intervention to&#xD;
      target parents and providers of adolescents with DIC. DECIDE stands for Decide the problem;&#xD;
      Explore the questions; Closed or open-ended questions; Identify the who, why, or how of the&#xD;
      problem; Direct questions to your health care professional; Enjoy a shared solution. DECIDE&#xD;
      was developed for ethnically/racially diverse adult patients with serious mental illness and&#xD;
      the latest evidence-based iterations include intervention components targeted to and shown to&#xD;
      increase patient activation, provider communication, and patient-provider interactions.&#xD;
&#xD;
      DECIDE has two primary components: 1) three patient training sessions designed to help&#xD;
      patients effectively ask questions and participate in decisions about their care: and 2) a&#xD;
      4-hour workshop for providers to improve perspective-taking, reduce attributional errors, and&#xD;
      increase receptivity to parent participation and collaboration. The purposes of this&#xD;
      two-phase study are: Phase I, Aim 1.&#xD;
&#xD;
      Modify the DECIDE intervention for parents and providers of adolescents with DIC. Phase II,&#xD;
      Aim 2. Evaluate the feasibility and acceptability of modified DECIDE. Aim 3. Estimate&#xD;
      preliminary effects of modified DECIDE to improve parent, provider, and adolescent outcomes.&#xD;
&#xD;
      Innovative features of this study are the proposed focus on both parents and providers; and&#xD;
      inclusion of parent activation and provider communication, which are new in field of child&#xD;
      and adolescent behavioral health care, and focus on low income and minority parents. The&#xD;
      investigators expect to find that compared to usual care: Hypothesis 3.1. Modified DECIDE&#xD;
      parents will show greater improvements in: 1) activation; 2) parent-provider interactions; 3)&#xD;
      perceived management of adolescents' behavioral health care, 4) perceived quality of&#xD;
      adolescents' behavioral health care, and 5) engagement in adolescents' behavioral healthcare.&#xD;
      Hypothesis 3.2. Modified DECIDE providers will show greater improvements in: 1) communication&#xD;
      skills; and 2) parent-provider interactions. Hypothesis 3.3. Adolescents of modified DECIDE&#xD;
      parents and providers will show higher rates of retention in behavioral health care. Sample&#xD;
      will include 16 providers and their parents ( ~ 5 parents per provider, n= 80) recruited from&#xD;
      the Child and Adolescents Program of a large safety net health system setting that serves&#xD;
      predominately low income and minority persons. Feasibility will be assessed using tracking&#xD;
      logs and field notes, and acceptability through parent and provider satisfaction scores and&#xD;
      in depth, semi structured interviews. Outcomes will be assessed at baseline and within 4&#xD;
      weeks post- intervention using standardized questionnaires or surveys from parents,&#xD;
      providers, and independent observers reports. Effects sizes will be estimated using linear&#xD;
      mixed models. If study findings are positive, we will be poised to test the modified DECIDE&#xD;
      intervention in a fully powered R01 level randomized, controlled, multi-site clinical trial.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2020</start_date>
  <completion_date type="Actual">December 30, 2022</completion_date>
  <primary_completion_date type="Actual">December 30, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>For clarity, each intervention group was separate and not comparable to other intervention groups.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Parent Activation Measure Mental Health (P-PAM-MH): baseline</measure>
    <time_frame>Baseline (TI)</time_frame>
    <description>13-item scale measures parent activation for use with parents of youth with emotional and behavioral disorders [126]. It was adapted from the original PAM. Items are scored using a 4-point Likert-type scale (1 = disagree strongly to 4 = agree strongly). Raw scores are summed and scaled from 0-100. Higher scores indicate greater activation. Cronbach alpha is 0.89. To be completed by Parents.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Parent Activation Measure Mental Health (P-PAM-MH): post-intervention</measure>
    <time_frame>Immediately post intervention (T2)</time_frame>
    <description>13-item scale measures parent activation for use with parents of youth with emotional and behavioral disorders [126]. It was adapted from the original PAM. Items are scored using a 4-point Likert-type scale (1 = disagree strongly to 4 = agree strongly). Raw scores are summed and scaled from 0-100. Higher scores indicate greater activation. Cronbach alpha is 0.89. To be completed by Parents.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Communication Scale of the Kim Alliance Scale Refined (KAS-R): baseline</measure>
    <time_frame>Baseline (T1)</time_frame>
    <description>4-item scale measures provider perception of parent-provider communication. Response categories include 1-never to 4 = always. Items are summed with higher scores indicating higher quality of communication. Cronbach alpha is 0.94.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Communication Scale of the Kim Alliance Scale Refined (KAS-R): post-intervention</measure>
    <time_frame>Immediately post intervention (T2)</time_frame>
    <description>4-item scale measures provider perception of parent-provider communication. Response categories include 1-never to 4 = always. Items are summed with higher scores indicating higher quality of communication. Cronbach alpha is 0.94.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Perceived Efficacy in Parent-Physician Interactions (PEPPI)-Short Form: baseline</measure>
    <time_frame>Baseline (T1)</time_frame>
    <description>Parent assessment is 5-item scale, measures patient's confidence in ability to elicit and understand information from and communicate information to providers.&#xD;
Response categories are 1 = low to 10 = high. A total score is obtained by summing all individual scores. Cronbach's alpha = 0.83.&#xD;
To be completed by parents.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Perceived Efficacy in Parent-Physician Interactions (PEPPI)-Short Form: post-intervention</measure>
    <time_frame>Immediately post intervention (T2)</time_frame>
    <description>Parent assessment is 5-item scale, measures patient's confidence in ability to elicit and understand information from and communicate information to providers.&#xD;
Response categories are 1 = low to 10 = high. A total score is obtained by summing all individual scores. Cronbach's alpha = 0.83.&#xD;
To be completed by parents.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Perception of Care Quality Survey: baseline</measure>
    <time_frame>Baseline (T1)</time_frame>
    <description>18-item scale measures parent's perception of care quality. Higher scores indicate perceptions of higher quality of care [125].To be completed by parents.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Perception of Care Quality Survey: post-intervention</measure>
    <time_frame>Immediately post intervention (T2)</time_frame>
    <description>18-item scale measures parent's perception of care quality. Higher scores indicate perceptions of higher quality of care [125].To be completed by parents.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Parent Participation Engagement Measure (PPEM): baseline</measure>
    <time_frame>Baseline (T1)</time_frame>
    <description>The 5-item scale measures the frequency with which the parent engaged during clinical encounter or parent-provider interaction. Behaviors assessed include asking questions, making suggestions or sharing one's opinion or point of view, and participating in therapeutic activities. Response options are on a 5-point scale ranging from 1 = &quot;not at all&quot; to 5 = &quot;very much&quot;. Higher scores indicate greater frequency of parent engagement. Cronbach alpha = 0.88 [122]. To be completed by providers and parents.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Parent Participation Engagement Measure (PPEM): post-intervention</measure>
    <time_frame>Immediately post intervention (T2)</time_frame>
    <description>The 5-item scale measures the frequency with which the parent engaged during clinical encounter or parent-provider interaction. Behaviors assessed include asking questions, making suggestions or sharing one's opinion or point of view, and participating in therapeutic activities. Response options are on a 5-point scale ranging from 1 = &quot;not at all&quot; to 5 = &quot;very much&quot;. Higher scores indicate greater frequency of parent engagement. Cronbach alpha = 0.88 [122]. To be completed by providers and parents.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Parent Needs &amp; Resources Domain of CANS</measure>
    <time_frame>Baseline (T1)</time_frame>
    <description>Three items from the Parent Needs &amp; Resources Domain of the CANS were given (Involvement with Care, Knowledge, and Organization). Each question is scored 0, 1, 2, or 3. A domain score can be created by averaging the items. High scores mean more need/less strength. To be completed by Providers.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Parent Needs &amp; Resources Domain of CANS</measure>
    <time_frame>Immediately post intervention (T2)</time_frame>
    <description>Three items from the Parent Needs &amp; Resources Domain of the CANS were given (Involvement with Care, Knowledge, and Organization). Each question is scored 0, 1, 2, or 3. A domain score can be created by averaging the items. High scores mean more need/less strength. To be completed by Providers.</description>
  </primary_outcome>
  <other_outcome>
    <measure>Pre-test</measure>
    <time_frame>Baseline (T1)</time_frame>
    <description>5 question survey that measures the provider's perspective on how significant poor parent engagement is. It also measures the provider's familiarity with the following terms: perspective taking, attribution errors, and receptivity. Investigator derived.</description>
  </other_outcome>
  <other_outcome>
    <measure>Post Test</measure>
    <time_frame>Immediately post intervention (T2)</time_frame>
    <description>7 question survey designed to gather feedback about the DECIDE training for providers. Also measures the provider's familiarity with the following terms post intervention: perspective taking, attribution errors, and receptivity. Investigator derived.</description>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">89</enrollment>
  <condition>Modified DECIDE Intervention</condition>
  <condition>Treatment as Usual Care Group</condition>
  <arm_group>
    <arm_group_label>Modified DECIDE-Provider Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>2-4 hour workshop for providers to improve perspective-taking, reduce attributional errors, and increase receptivity to parent participation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Modified DECIDE-Parent Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Up to three parent training sessions designed to help patients effectively ask questions and participate in decisions about care.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Provider Subgroup Study</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>To boost provider recruitment, we sought recommendations from a subgroup of providers. We gave each provider access to the DECIDE online training and the pre- and post-survey.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment as Usual</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Control arm</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Modified DECIDE Parent and Provider Intervention</intervention_name>
    <description>The parent component will include up to three 60 minutes sessions. Session 1 (Decisions and Agency) is designed to increase awareness of their role in clinical interactions and encourage participation and decision making in care. Session 2 (the Who, How, and Why of Decisions) teach skills for understanding treatment decisions in terms of roles, processes, and reasons involved. Session 3 (Self-efficacy and Consolidation) encourages parents to ask questions about their adolescents' behavioral health and health care and treatment options. The provider component is designed to improve provider communication in three key areas: 1) perspective taking to understand circumstances and perceptions; 2) attributional errors or attributing negative parent behaviors to character traits; and 3) receptivity to parent participation and collaboration.</description>
    <arm_group_label>Modified DECIDE-Parent Arm</arm_group_label>
    <arm_group_label>Modified DECIDE-Provider Arm</arm_group_label>
    <arm_group_label>Provider Subgroup Study</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Phase 1, Aim 1.&#xD;
&#xD;
        Inclusion Criteria (for Parent Advisory Board; to assist with intervention development):&#xD;
&#xD;
        1. Parents of adolescents with DIC, who are receiving services at Midtown Child and&#xD;
        Adolescent Program or CAP. (We will invite parents 1) from our previous study advisory&#xD;
        board (n=3), and two who participated in preliminary study 2 that agreed to be contacted&#xD;
        for future studies.)&#xD;
&#xD;
        Inclusion Criteria (for Provider Advisory Board; to assist with intervention development):&#xD;
&#xD;
        1. CAP staffs who do not meet the inclusion criteria in phase 2 (i.e. manager and clinical&#xD;
        coordinators or supervisors, clinic nurse, advanced practice registered nurses, or&#xD;
        psychiatrists). (We will invite two other direct care providers who work in the healthcare&#xD;
        system but not at recruitment site. No providers or parents will be excluded on basis of&#xD;
        race/ethnicity, gender, or sexual orientation.)&#xD;
&#xD;
        Phase II, Aims 2 and 3.&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
        Inclusion Criteria for providers and interns: Providers will be regular paid staff members&#xD;
        who are:&#xD;
&#xD;
          1. Associate's or bachelor's or PhD prepared providers who work with parents OR&#xD;
&#xD;
          2. Masters-prepared clinical social workers or mental health counselors and&#xD;
&#xD;
          3. Provide behavioral health services to adolescents and their parents. OR&#xD;
&#xD;
          4. Doctoral level interns (e.g. in psychology) and&#xD;
&#xD;
          5. Provide behavioral health services to adolescents and their parents OR&#xD;
&#xD;
          6. Providers who are bachelor's prepared interns must:&#xD;
&#xD;
        (1) be currently working with a center or private practice to complete requirements for&#xD;
        their Master's degree and (2) be providing behavioral health services to adolescents and&#xD;
        their parents.&#xD;
&#xD;
        Inclusion Criteria for Guardians: Guardians will have a child or adolescent with DIC&#xD;
        receiving services from a participating mental health provider. Parents/guardians meeting&#xD;
        all the following criteria are eligible:&#xD;
&#xD;
          1. are aged 21 or older&#xD;
&#xD;
          2. speak English&#xD;
&#xD;
          3. are the guardian (biological parent, adoptive parent, step parent, foster parent, or&#xD;
             legal guardian) of the child or adolescent or a parent surrogate serving in a primary&#xD;
             caregiver role (referred to as &quot;parents&quot;; if foster parent or legal guardian, ).&#xD;
&#xD;
          4. must have a child or adolescent aged 3 to 17 years with a diagnosis of Disruptive&#xD;
             Impulse Control and Conduct Disorder (DIC) by a mental health professional. (This&#xD;
             includes children with behavior problems, such as Oppositional Defiant disorder,&#xD;
             Conduct disorders, or Intermittent Explosive disorders).&#xD;
&#xD;
          5. Attends regular appointments with a provider&#xD;
&#xD;
          6. Foster parents will be included if they have a child with DIC now or in the past, and&#xD;
             regardless of whether that child is receiving services from a participating mental&#xD;
             health provider or not.&#xD;
&#xD;
        Exclusion Criteria for parents:&#xD;
&#xD;
          -  Show significant cognitive impairment or acute emotional distress on screening&#xD;
&#xD;
          -  Have an incarcerated adolescent&#xD;
&#xD;
        No providers or parents will be excluded on basis of race/ethnicity, gender, or sexual&#xD;
        orientation.&#xD;
&#xD;
        Specifically for semi-structured interview post intervention. Include: All intervention&#xD;
        providers (n = 8) and two of each of their parents (n = 16). To explore different levels of&#xD;
        acceptability by parents, for each provider, one parent will be chosen who has a high score&#xD;
        (&gt; 3) on the CSQ and one parent who has a low score (&lt; 3). Both parents and providers will&#xD;
        be asked about their experience with the intervention, what was helpful or not, and how&#xD;
        they would change the intervention.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ukamaka M Oruche, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>IU Nursing</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centerstone</name>
      <address>
        <city>Sarasota</city>
        <state>Florida</state>
        <zip>34233</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centerstone</name>
      <address>
        <city>Bloomington</city>
        <state>Indiana</state>
        <zip>47404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bowen Center</name>
      <address>
        <city>Fort Wayne</city>
        <state>Indiana</state>
        <zip>46808</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sandra Eskenazi Mental Health Center</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centerstone</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>February 2, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 24, 2020</study_first_posted>
  <last_update_submitted>April 24, 2023</last_update_submitted>
  <last_update_submitted_qc>April 24, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 26, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Indiana University</investigator_affiliation>
    <investigator_full_name>Ukamaka Marian Oruche</investigator_full_name>
    <investigator_title>Project Director</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>December 6, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/55/NCT04445155/Prot_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>December 6, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/55/NCT04445155/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT04445155
org study id: 1911897011
secondary id: 5R21MD015150-02
nct id: NCT04445155
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The DECIDE Parent-Provider Intervention is designed to support parents caring for adolescents
      who are receiving treatment for Disruptive, Impulse-Control, and Conduct disorders.
      Participating in DECIDE study may help you effectively ask questions and participate in
      decisions about your adolescent's care.
Interventions to optimize parent-provider interactions are urgently needed to ensure
      adolescents aged 3 to 17 years with Disruptive, Impulse-Control, and Conduct disorders (DIC)
      receive the behavioral health care they need. For these adolescents, behavioral health care
      is complex, long-term, and requires parental participation. Research shows providers have
      biases and limited skills and confidence to communicate with these parents to encourage them
      to voice their concerns and care preferences. Low income and minority parents are at greatest
      risk of not being involved in their adolescents' behavioral health care, having poor
      interactions with providers, and are more likely to perceive poor quality of their
      adolescents' behavioral health care, and low treatment engagement. If unaddressed, poor
      parent-provider interactions interfere with adolescents' retention in behavioral health care.

      No evidence-based interventions have targeted both parents and providers to optimize their
      interactions and improve behavioral health care for adolescents with DIC. To address these
      problems, the investigators propose modifying the evidence-based DECIDE intervention to
      target parents and providers of adolescents with DIC. DECIDE stands for Decide the problem;
      Explore the questions; Closed or open-ended questions; Identify the who, why, or how of the
      problem; Direct questions to your health care professional; Enjoy a shared solution. DECIDE
      was developed for ethnically/racially diverse adult patients with serious mental illness and
      the latest evidence-based iterations include intervention components targeted to and shown to
      increase patient activation, provider communication, and patient-provider interactions.

      DECIDE has two primary components: 1) three patient training sessions designed to help
      patients effectively ask questions and participate in decisions about their care: and 2) a
      4-hour workshop for providers to improve perspective-taking, reduce attributional errors, and
      increase receptivity to parent participation and collaboration. The purposes of this
      two-phase study are: Phase I, Aim 1.

      Modify the DECIDE intervention for parents and providers of adolescents with DIC. Phase II,
      Aim 2. Evaluate the feasibility and acceptability of modified DECIDE. Aim 3. Estimate
      preliminary effects of modified DECIDE to improve parent, provider, and adolescent outcomes.

      Innovative features of this study are the proposed focus on both parents and providers; and
      inclusion of parent activation and provider communication, which are new in field of child
      and adolescent behavioral health care, and focus on low income and minority parents. The
      investigators expect to find that compared to usual care: Hypothesis 3.1. Modified DECIDE
      parents will show greater improvements in: 1) activation; 2) parent-provider interactions; 3)
      perceived management of adolescents' behavioral health care, 4) perceived quality of
      adolescents' behavioral health care, and 5) engagement in adolescents' behavioral healthcare.
      Hypothesis 3.2. Modified DECIDE providers will show greater improvements in: 1) communication
      skills; and 2) parent-provider interactions. Hypothesis 3.3. Adolescents of modified DECIDE
      parents and providers will show higher rates of retention in behavioral health care. Sample
      will include 16 providers and their parents ( ~ 5 parents per provider, n= 80) recruited from
      the Child and Adolescents Program of a large safety net health system setting that serves
      predominately low income and minority persons. Feasibility will be assessed using tracking
      logs and field notes, and acceptability through parent and provider satisfaction scores and
      in depth, semi structured interviews. Outcomes will be assessed at baseline and within 4
      weeks post- intervention using standardized questionnaires or surveys from parents,
      providers, and independent observers reports. Effects sizes will be estimated using linear
      mixed models. If study findings are positive, we will be poised to test the modified DECIDE
      intervention in a fully powered R01 level randomized, controlled, multi-site clinical trial.
allocation: Non-Randomized
intervention model: Single Group Assignment
intervention model description: For clarity, each intervention group was separate and not comparable to other intervention groups.
primary purpose: Treatment
masking: None (Open Label)
measure: Parent Activation Measure Mental Health (P-PAM-MH): baseline
time frame: Baseline (TI)
description: 13-item scale measures parent activation for use with parents of youth with emotional and behavioral disorders [126]. It was adapted from the original PAM. Items are scored using a 4-point Likert-type scale (1 = disagree strongly to 4 = agree strongly). Raw scores are summed and scaled from 0-100. Higher scores indicate greater activation. Cronbach alpha is 0.89. To be completed by Parents.
measure: Parent Activation Measure Mental Health (P-PAM-MH): post-intervention
time frame: Immediately post intervention (T2)
description: 13-item scale measures parent activation for use with parents of youth with emotional and behavioral disorders [126]. It was adapted from the original PAM. Items are scored using a 4-point Likert-type scale (1 = disagree strongly to 4 = agree strongly). Raw scores are summed and scaled from 0-100. Higher scores indicate greater activation. Cronbach alpha is 0.89. To be completed by Parents.
measure: Communication Scale of the Kim Alliance Scale Refined (KAS-R): baseline
time frame: Baseline (T1)
description: 4-item scale measures provider perception of parent-provider communication. Response categories include 1-never to 4 = always. Items are summed with higher scores indicating higher quality of communication. Cronbach alpha is 0.94.
measure: Communication Scale of the Kim Alliance Scale Refined (KAS-R): post-intervention
time frame: Immediately post intervention (T2)
description: 4-item scale measures provider perception of parent-provider communication. Response categories include 1-never to 4 = always. Items are summed with higher scores indicating higher quality of communication. Cronbach alpha is 0.94.
measure: Perceived Efficacy in Parent-Physician Interactions (PEPPI)-Short Form: baseline
time frame: Baseline (T1)
description: Parent assessment is 5-item scale, measures patient's confidence in ability to elicit and understand information from and communicate information to providers.
Response categories are 1 = low to 10 = high. A total score is obtained by summing all individual scores. Cronbach's alpha = 0.83.
To be completed by parents.
measure: Perceived Efficacy in Parent-Physician Interactions (PEPPI)-Short Form: post-intervention
time frame: Immediately post intervention (T2)
description: Parent assessment is 5-item scale, measures patient's confidence in ability to elicit and understand information from and communicate information to providers.
Response categories are 1 = low to 10 = high. A total score is obtained by summing all individual scores. Cronbach's alpha = 0.83.
To be completed by parents.
measure: Perception of Care Quality Survey: baseline
time frame: Baseline (T1)
description: 18-item scale measures parent's perception of care quality. Higher scores indicate perceptions of higher quality of care [125].To be completed by parents.
measure: Perception of Care Quality Survey: post-intervention
time frame: Immediately post intervention (T2)
description: 18-item scale measures parent's perception of care quality. Higher scores indicate perceptions of higher quality of care [125].To be completed by parents.
measure: Parent Participation Engagement Measure (PPEM): baseline
time frame: Baseline (T1)
description: The 5-item scale measures the frequency with which the parent engaged during clinical encounter or parent-provider interaction. Behaviors assessed include asking questions, making suggestions or sharing one's opinion or point of view, and participating in therapeutic activities. Response options are on a 5-point scale ranging from 1 = "not at all" to 5 = "very much". Higher scores indicate greater frequency of parent engagement. Cronbach alpha = 0.88 [122]. To be completed by providers and parents.
measure: Parent Participation Engagement Measure (PPEM): post-intervention
time frame: Immediately post intervention (T2)
description: The 5-item scale measures the frequency with which the parent engaged during clinical encounter or parent-provider interaction. Behaviors assessed include asking questions, making suggestions or sharing one's opinion or point of view, and participating in therapeutic activities. Response options are on a 5-point scale ranging from 1 = "not at all" to 5 = "very much". Higher scores indicate greater frequency of parent engagement. Cronbach alpha = 0.88 [122]. To be completed by providers and parents.
measure: Parent Needs & Resources Domain of CANS
time frame: Baseline (T1)
description: Three items from the Parent Needs & Resources Domain of the CANS were given (Involvement with Care, Knowledge, and Organization). Each question is scored 0, 1, 2, or 3. A domain score can be created by averaging the items. High scores mean more need/less strength. To be completed by Providers.
measure: Parent Needs & Resources Domain of CANS
time frame: Immediately post intervention (T2)
description: Three items from the Parent Needs & Resources Domain of the CANS were given (Involvement with Care, Knowledge, and Organization). Each question is scored 0, 1, 2, or 3. A domain score can be created by averaging the items. High scores mean more need/less strength. To be completed by Providers.
measure: Pre-test
time frame: Baseline (T1)
description: 5 question survey that measures the provider's perspective on how significant poor parent engagement is. It also measures the provider's familiarity with the following terms: perspective taking, attribution errors, and receptivity. Investigator derived.
measure: Post Test
time frame: Immediately post intervention (T2)
description: 7 question survey designed to gather feedback about the DECIDE training for providers. Also measures the provider's familiarity with the following terms post intervention: perspective taking, attribution errors, and receptivity. Investigator derived.
arm group label: Modified DECIDE-Provider Arm
arm group type: Experimental
description: 2-4 hour workshop for providers to improve perspective-taking, reduce attributional errors, and increase receptivity to parent participation.
arm group label: Modified DECIDE-Parent Arm
arm group type: Experimental
description: Up to three parent training sessions designed to help patients effectively ask questions and participate in decisions about care.
arm group label: Provider Subgroup Study
arm group type: Other
description: To boost provider recruitment, we sought recommendations from a subgroup of providers. We gave each provider access to the DECIDE online training and the pre- and post-survey.
arm group label: Treatment as Usual
arm group type: No Intervention
description: Control arm
intervention type: Behavioral
intervention name: Modified DECIDE Parent and Provider Intervention
description: The parent component will include up to three 60 minutes sessions. Session 1 (Decisions and Agency) is designed to increase awareness of their role in clinical interactions and encourage participation and decision making in care. Session 2 (the Who, How, and Why of Decisions) teach skills for understanding treatment decisions in terms of roles, processes, and reasons involved. Session 3 (Self-efficacy and Consolidation) encourages parents to ask questions about their adolescents' behavioral health and health care and treatment options. The provider component is designed to improve provider communication in three key areas: 1) perspective taking to understand circumstances and perceptions; 2) attributional errors or attributing negative parent behaviors to character traits; and 3) receptivity to parent participation and collaboration.
arm group label: Modified DECIDE-Parent Arm
arm group label: Modified DECIDE-Provider Arm
arm group label: Provider Subgroup Study
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Ukamaka M Oruche, PhD
role: Principal Investigator
affiliation: IU Nursing
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facility: 
facility: 
facility: 
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country: United States
responsible party type: Principal Investigator
investigator affiliation: Indiana University
investigator full name: Ukamaka Marian Oruche
investigator title: Project Director
sharing ipd: No
provided document: 
provided document: 