<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/NCT03751345</url>
  </required_header>
  <id_info>
    <org_study_id>1R34MH113598-01A1</org_study_id>
    <nct_id>NCT03751345</nct_id>
  </id_info>
  <brief_title>Computerized Parenting Intervention</brief_title>
  <official_title>Integrating Computer-Assisted Parent Training Therapy Into Community Mental Health Clinic Practice</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rhode Island Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rhode Island Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will evaluate a low-cost, low-intensity, computer-based model for delivering&#xD;
      parenting skills to parents of adolescents in a community mental health clinic. This&#xD;
      intervention has the potential to improve public health and community practice by making&#xD;
      empirically-supported treatment techniques more available. We believe this approach will&#xD;
      improve the efficiency of treatment delivery by integrating computerized and therapist&#xD;
      delivered approaches, and there is potential for significant improvements in efficacy of&#xD;
      parent training with this model.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will evaluate a low cost, low intensity, technology based model for delivering&#xD;
      parenting skills to parents of adolescents in a community mental health clinic (CMHC).&#xD;
      Specifically, we will test a computer-assisted protocol of Parenting Wisely, a computer based&#xD;
      parenting program with previously established efficacy. Such an intervention is consistent&#xD;
      with NIMH strategic plan objective 3.3: &quot;to strengthen the application of mental health&#xD;
      interventions in diverse care settings by examining community and intervention delivery&#xD;
      approaches and how they may affect intervention outcomes.&quot; Although this is a pilot&#xD;
      effectiveness study, we will gather information to inform future implementation efforts&#xD;
      including the feasibility and acceptability of the intervention. Additionally, we will&#xD;
      conduct qualitative interviews with relevant stakeholders (providers/program managers) to&#xD;
      better understand barriers and facilitators of adoption and sustainability. This goal will&#xD;
      help increase the likelihood of a successful, future larger trial across multiple CMHCs due&#xD;
      to its focus on external validity and implementation barriers when making critical design&#xD;
      decisions. This approach mitigates a major criticism of traditional efficacy/effectiveness&#xD;
      studies, i.e. that the methods do not translate well to the community due to cost and&#xD;
      resource constraints, as well as contextual factors.&#xD;
&#xD;
      The intervention has the potential to improve public health and community practice by making&#xD;
      empirically supported treatment techniques more available in CMHCs and improving the&#xD;
      efficiency of treatment delivery by integrating computerized and therapist delivered&#xD;
      approaches. Specifically, this study has the potential to advance treatment by: 1)&#xD;
      understanding factors that enhance or impede computer assisted parent training in the&#xD;
      community setting; 2) addressing a high-needs underserved population with significant public&#xD;
      health relevance; 3) engaging the target mechanism of therapist fidelity, competency, and&#xD;
      alliance as well as parenting skills and self-efficacy that have been shown to influence&#xD;
      adolescent behavior problems; 4) increasing access to and engagement in an evidence-based&#xD;
      treatment that can be personalized to the specific parenting skills of a family by the&#xD;
      selection of modules in PW; and 5) enhancing the ease of dissemination and implementation.&#xD;
      Furthermore, we believe this approach has the potential for improving response rate, because&#xD;
      the parenting skills will be delivered with greater fidelity than would be typical of&#xD;
      therapists teaching parenting in sessions in CHMCs. This improvement should also result in an&#xD;
      improved response in adolescent behavior. We believe this is true because: 1) meta-analyses&#xD;
      typically report moderate effect sizes for parent training at the end of treatment; 2) parent&#xD;
      training is underemployed in community clinics; 3) fidelity to treatment protocols is often&#xD;
      poor which has been shown to diminish effectiveness of treatment; and 4) frequent staff&#xD;
      turnover creates high resource demands. Thus, we believe this approach is not only efficient&#xD;
      but that there is potential for significant improvements in efficacy of parent training with&#xD;
      this model.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 29, 2018</start_date>
  <completion_date type="Anticipated">May 2021</completion_date>
  <primary_completion_date type="Anticipated">May 2021</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>Parallel Assignment</intervention_model>
    <intervention_model_description>In the Open Trial, all participants will receive PW. In the RCT phase, adolescents will be randomly assigned to one of the two conditions. After completion of the baseline assessment, random assignment of adolescents using blocking and stratification will be automatically generated by the electronic data capture software REDCap. Random block sizes of assignments will be generated to prevent guessing of pending treatment assignments. Stratification will be used to ensure a balance on biological sex and disruptive behavior disorder severity (more of less than T=85), as indicated on the CBCL.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Psychometric Analysis of the Perceptions of Computerized Therapy Questionnaire-Patient Version</measure>
    <time_frame>Change from Baseline Psychometric Analysis of the Perceptions of Computerized Therapy at 6 months</time_frame>
    <description>The PCTQ-P is an instrument for assessing consumers' perceptions of computer-based therapies that are distinguishable from traditional help-seeking attitudes. There are 35 items that can be divided in 6 sub-scales to measure subtle perceptions; relative advantage, compatibility, complexity, observability, trial-ability and future use intentions.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Consumer Satisfaction Questionnaire</measure>
    <time_frame>3 months after start of intervention</time_frame>
    <description>The CSQ asks parents to rate their satisfaction with treatment delivery, their child's treatment progress, and their ability to manage their child's problems. Parents rate 11 items along a 7-point scale and answer 5 open-ended questions about their experience in treatment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Psychometric Analysis of the Perceptions of Computerized Therapy Questionnaire- Clinician Version</measure>
    <time_frame>Change from Baseline Psychometric Analysis of the Perceptions of Computerized Therapy at 3 months and 6 months</time_frame>
    <description>an instrument for assessing clinicians' perceptions of computer-based therapies that are distinguishable from traditional help-seeking attitudes. There are 35 items that can be divided in 6 subscales to measure subtle perceptions; relative advantage, compatibility, complexity, observability, trial-ability and future use intentions.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Evidence-Based Practice Attitude Scale</measure>
    <time_frame>Change from Baseline Evidence-Based Practice Attitude Scale at 3 months and 6 months</time_frame>
    <description>A 15 question reliable tool to evaluate the attitudes of providers who specialize in child and adolescent mental health toward Evidence Based Practice.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Perceived Characteristics of Intervention Scale</measure>
    <time_frame>Change from Baseline Perceived Characteristics of Intervention Scale at 3 months and 6 months</time_frame>
    <description>The PCIS is a 20 question reliable assessment measure of perceived characteristics of interventions, and will be specified towards the intervention, Parenting Wisely.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Qualitative Interviews</measure>
    <time_frame>Change from Baseline Qualitative Interviews at 3 months and 6 months</time_frame>
    <description>Qualitative feedback from interviews with parents, providers, and program managers will also be conducted. All quaAlitative interviews will be videotaped, transcribed verbatim and coded for nonverbal behaviors in addition to verbal content. We will use an interview guide to ensure the adequacy and quality of data. The guide will be refined to reflect unanticipated topics that arise and integrate these emergent topics and questions[40]. We will approach the interview as a collaborative process with participants and interviewers will encourage each participant to talk freely about the therapeutic process, coverage of parenting skills, and topic areas in PW. Broad questions will be followed by probes and unstructured questions based on areas raised by participants to encourage elaboration and clarification but limit influence from the interviewer.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Pediatric Symptom Checklist</measure>
    <time_frame>Change from Screening Pediatric Symptom Checklist at 3 months and 6 months</time_frame>
    <description>A well-known measure to help primary care providers assess the likelihood of finding any mental health disorder in their patient. The questionnaire consists of 17 items on behavior or emotional problems.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Parent Monitoring Questionnaire</measure>
    <time_frame>Baseline assessment, 3 months after start of intervention, 6 months after start of intervention</time_frame>
    <description>The PMQ is a 24 item youth and parent report measure designed to assess parental monitoring and sources of parental knowledge. The monitoring subscale has demonstrated good reliability (alpha = .82 parents, .85 youth) and correlates with adolescent internalizing and externalizing maladjustment, deviant peer relationships, and family discord.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>McMaster Family Assessment Device</measure>
    <time_frame>Baseline assessment, 3 months after start of intervention, 6 months after start of intervention</time_frame>
    <description>This measure includes the following sub-scales assessing parenting skills: Problem Solving (i.e., the family's ability to resolve problems in ways that maintain effective family functioning.); Family Roles (i.e., the extent to which tasks are clearly and equitably distributed among family members); Communication (i.e., the extent to which verbal messages between family members are clear); Affective Involvement (i.e., the extent to which family members are interested in and placed value on each other's activities); Affective Responsiveness (i.e., the extent to which family members experience appropriate affect in response to stimuli); Behavioral Control (i.e., the extent to which the family expresses and maintains standards for the behavior of its members). All items are rated on a 4-point scale and the sub-scales have adequate reliability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parent-Adolescent Communication Scale</measure>
    <time_frame>Baseline assessment, 3 months after start of intervention, 6 months after start of intervention</time_frame>
    <description>The PACS is a youth and parent report measure that assesses positive and negative aspects of general parent-teen communication and the content and process of parent-teen interactions. The two sub-scales have good reliability (alpha = .77 - .88) and have been shown to correlate with teen engagement in problem behavior.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parenting Self Efficacy</measure>
    <time_frame>Baseline assessment, 3 months after start of intervention, 6 months after start of intervention</time_frame>
    <description>This 10-item scale assesses the degree of parents' confidence in implementing specific parenting skills.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>FAsTask Video Code</measure>
    <time_frame>Baseline assessment, 3 months after start of intervention, 6 months after start of intervention</time_frame>
    <description>The FAsTask is a video-taped family problem solving task that will be used to provide an in-vivo assessment of parenting behaviors. We have limited the assessment to tasks that align with our primary aims. Specifically, parent-teen dyads will be prompted to spend 5 minutes on each of the following: 1) teen leads a discussion about a time without supervision and parents seek additional information (monitoring and listening); 2) parents lead a discussion on setting limits over the previous month (limit setting) and then communicate rules to the teen; 3) parents and teens problem solve around an issue; and 4) positive recognition when the parent praises the teen.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Issues Checklist</measure>
    <time_frame>Baseline assessment, 3 months after start of intervention, 6 months after start of intervention</time_frame>
    <description>This measure will work to decipher distressed families versus non distressed families and addressing and identifying the issues.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disruptive Behavior Disorder Rating Scale</measure>
    <time_frame>Baseline assessment, 3 months after start of intervention, 6 months after start of intervention</time_frame>
    <description>The DBDRS which is comprised of the DSM symptom lists for ADHD, ODD, and CD. It uses a 4-point response scale completed by parents for questions regarding ADHD and ODD and a yes/no format for CD symptoms to assess behavior problems within the past month. The DBDRS has been shown to have excellent psychometric properties</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Child and Adolescent Services Assessment (CASA)</measure>
    <time_frame>Baseline assessment, 3 months after start of intervention, 6 months after start of intervention</time_frame>
    <description>This is a semi structured interview for parents and teens/children to assess service utilization for emotional, behavioral, and substance use problems. It addresses a range of services including inpatient, emergency room services, residential treatment centers, detention centers, probation, foster home services, hospitalization, in-home services, family therapy and outpatient services. The teen will complete questions regarding services related to school including boarding school, therapeutic/behavioral school, school support and school professional services</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Working Alliance Inventory</measure>
    <time_frame>3 months after start of intervention.</time_frame>
    <description>The WAI is an 11-item measure in which parents are asked to rate their alliance with their therapists on a 7-point Likert scale. This measure examines factors such as having a collaborative approach to treatment, perceived expertise, trust, and establishing shared goals.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Parenting</condition>
  <condition>Adolescent Problem Behavior</condition>
  <arm_group>
    <arm_group_label>Treatment As Usual (TAU)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The TAU condition consists of the standard treatment elements offered to all Gateway (study site) patients, and will be received by patients in both the PW and the TAU-only condition. TAU services during the adolescent's treatment are typically eclectic and mainly entail meeting with the adolescent alone to provide support and psychoeducation, with occasional family therapy sessions. Medication management is offered as needed.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Parenting Wisely (PW)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In addition to TAU services, the PW arm includes in-person sessions where parents complete computer-administered PW sessions, in-person session including therapist coaching to reinforce PW material and personalize treatment by applying PW skills to individual issues, and access to PW material remotely so parents can access information and skills from home as needed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Parenting Wisely</intervention_name>
    <description>PW is a self-administered, interactive, multimedia online program. Parents will complete computer-administered sessions during in-person appointments.The program comes with a parent workbook so that parents can gain additional exposure to and practice with the skills. The complete PW program takes from 3 to 5 hours to complete depending on the users' speed and depth of use. Parents will be given a login at enrollment so that they have the option to practice sessions or view any additional sessions at home. Individual coaching sessions will take place in-person with parents. Coaching sessions are designed to tailor the PW skills to each parent's presenting concerns.</description>
    <arm_group_label>Parenting Wisely (PW)</arm_group_label>
    <other_name>PW</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  be the parent or legal guardian of an adolescent aged 12-17 years&#xD;
&#xD;
          -  have an adolescent with clinically elevated disruptive behaviors as indicated by&#xD;
             parent report on the Child Behavior Checklist (CBCL; Achenbach, 2000; Aggressive&#xD;
             Problems or Oppositional/Defiant Problems T score &gt; 70)&#xD;
&#xD;
          -  be willing to receive a parenting intervention&#xD;
&#xD;
          -  be fluent in English or Spanish&#xD;
&#xD;
          -  be willing to provide written consent and teen willing to provide written assent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  severe clinical presentations, such as psychosis or developmental delay, at a level&#xD;
             that would interfere with the ability to assent or complete assessments&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Jennifer Wolff, PhD</last_name>
    <phone>401-444-3790</phone>
    <email>jwolff2@lifespan.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Melanie Altemus, BA</last_name>
    <email>MAltemus@lifespan.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Gateway Healthcare Inc</name>
      <address>
        <city>Pawtucket</city>
        <state>Rhode Island</state>
        <zip>02860</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <email>MAltemus@lifespan.org</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>October 2, 2018</study_first_submitted>
  <study_first_submitted_qc>November 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 23, 2018</study_first_posted>
  <last_update_submitted>November 20, 2018</last_update_submitted>
  <last_update_submitted_qc>November 20, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 23, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rhode Island Hospital</investigator_affiliation>
    <investigator_full_name>Jennifer Wolff</investigator_full_name>
    <investigator_title>Staff Psychologist</investigator_title>
  </responsible_party>
  <keyword>Parenting skills</keyword>
  <keyword>Computer-based parenting program</keyword>
  <keyword>Parenting Wisely</keyword>
  <keyword>Adolescent disruptive behavior disorders</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Problem Behavior</mesh_term>
  </condition_browse>
  <!-- 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/NCT03751345
org study id: 1R34MH113598-01A1
nct id: NCT03751345
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study will evaluate a low-cost, low-intensity, computer-based model for delivering
      parenting skills to parents of adolescents in a community mental health clinic. This
      intervention has the potential to improve public health and community practice by making
      empirically-supported treatment techniques more available. We believe this approach will
      improve the efficiency of treatment delivery by integrating computerized and therapist
      delivered approaches, and there is potential for significant improvements in efficacy of
      parent training with this model.
This study will evaluate a low cost, low intensity, technology based model for delivering
      parenting skills to parents of adolescents in a community mental health clinic (CMHC).
      Specifically, we will test a computer-assisted protocol of Parenting Wisely, a computer based
      parenting program with previously established efficacy. Such an intervention is consistent
      with NIMH strategic plan objective 3.3: "to strengthen the application of mental health
      interventions in diverse care settings by examining community and intervention delivery
      approaches and how they may affect intervention outcomes." Although this is a pilot
      effectiveness study, we will gather information to inform future implementation efforts
      including the feasibility and acceptability of the intervention. Additionally, we will
      conduct qualitative interviews with relevant stakeholders (providers/program managers) to
      better understand barriers and facilitators of adoption and sustainability. This goal will
      help increase the likelihood of a successful, future larger trial across multiple CMHCs due
      to its focus on external validity and implementation barriers when making critical design
      decisions. This approach mitigates a major criticism of traditional efficacy/effectiveness
      studies, i.e. that the methods do not translate well to the community due to cost and
      resource constraints, as well as contextual factors.

      The intervention has the potential to improve public health and community practice by making
      empirically supported treatment techniques more available in CMHCs and improving the
      efficiency of treatment delivery by integrating computerized and therapist delivered
      approaches. Specifically, this study has the potential to advance treatment by: 1)
      understanding factors that enhance or impede computer assisted parent training in the
      community setting; 2) addressing a high-needs underserved population with significant public
      health relevance; 3) engaging the target mechanism of therapist fidelity, competency, and
      alliance as well as parenting skills and self-efficacy that have been shown to influence
      adolescent behavior problems; 4) increasing access to and engagement in an evidence-based
      treatment that can be personalized to the specific parenting skills of a family by the
      selection of modules in PW; and 5) enhancing the ease of dissemination and implementation.
      Furthermore, we believe this approach has the potential for improving response rate, because
      the parenting skills will be delivered with greater fidelity than would be typical of
      therapists teaching parenting in sessions in CHMCs. This improvement should also result in an
      improved response in adolescent behavior. We believe this is true because: 1) meta-analyses
      typically report moderate effect sizes for parent training at the end of treatment; 2) parent
      training is underemployed in community clinics; 3) fidelity to treatment protocols is often
      poor which has been shown to diminish effectiveness of treatment; and 4) frequent staff
      turnover creates high resource demands. Thus, we believe this approach is not only efficient
      but that there is potential for significant improvements in efficacy of parent training with
      this model.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: In the Open Trial, all participants will receive PW. In the RCT phase, adolescents will be randomly assigned to one of the two conditions. After completion of the baseline assessment, random assignment of adolescents using blocking and stratification will be automatically generated by the electronic data capture software REDCap. Random block sizes of assignments will be generated to prevent guessing of pending treatment assignments. Stratification will be used to ensure a balance on biological sex and disruptive behavior disorder severity (more of less than T=85), as indicated on the CBCL.
primary purpose: Treatment
masking: None (Open Label)
measure: Change in Psychometric Analysis of the Perceptions of Computerized Therapy Questionnaire-Patient Version
time frame: Change from Baseline Psychometric Analysis of the Perceptions of Computerized Therapy at 6 months
description: The PCTQ-P is an instrument for assessing consumers' perceptions of computer-based therapies that are distinguishable from traditional help-seeking attitudes. There are 35 items that can be divided in 6 sub-scales to measure subtle perceptions; relative advantage, compatibility, complexity, observability, trial-ability and future use intentions.
measure: Consumer Satisfaction Questionnaire
time frame: 3 months after start of intervention
description: The CSQ asks parents to rate their satisfaction with treatment delivery, their child's treatment progress, and their ability to manage their child's problems. Parents rate 11 items along a 7-point scale and answer 5 open-ended questions about their experience in treatment
measure: Change in Psychometric Analysis of the Perceptions of Computerized Therapy Questionnaire- Clinician Version
time frame: Change from Baseline Psychometric Analysis of the Perceptions of Computerized Therapy at 3 months and 6 months
description: an instrument for assessing clinicians' perceptions of computer-based therapies that are distinguishable from traditional help-seeking attitudes. There are 35 items that can be divided in 6 subscales to measure subtle perceptions; relative advantage, compatibility, complexity, observability, trial-ability and future use intentions.
measure: Change in Evidence-Based Practice Attitude Scale
time frame: Change from Baseline Evidence-Based Practice Attitude Scale at 3 months and 6 months
description: A 15 question reliable tool to evaluate the attitudes of providers who specialize in child and adolescent mental health toward Evidence Based Practice.
measure: Change in Perceived Characteristics of Intervention Scale
time frame: Change from Baseline Perceived Characteristics of Intervention Scale at 3 months and 6 months
description: The PCIS is a 20 question reliable assessment measure of perceived characteristics of interventions, and will be specified towards the intervention, Parenting Wisely.
measure: Change in Qualitative Interviews
time frame: Change from Baseline Qualitative Interviews at 3 months and 6 months
description: Qualitative feedback from interviews with parents, providers, and program managers will also be conducted. All quaAlitative interviews will be videotaped, transcribed verbatim and coded for nonverbal behaviors in addition to verbal content. We will use an interview guide to ensure the adequacy and quality of data. The guide will be refined to reflect unanticipated topics that arise and integrate these emergent topics and questions[40]. We will approach the interview as a collaborative process with participants and interviewers will encourage each participant to talk freely about the therapeutic process, coverage of parenting skills, and topic areas in PW. Broad questions will be followed by probes and unstructured questions based on areas raised by participants to encourage elaboration and clarification but limit influence from the interviewer.
measure: Change in Pediatric Symptom Checklist
time frame: Change from Screening Pediatric Symptom Checklist at 3 months and 6 months
description: A well-known measure to help primary care providers assess the likelihood of finding any mental health disorder in their patient. The questionnaire consists of 17 items on behavior or emotional problems.
measure: Parent Monitoring Questionnaire
time frame: Baseline assessment, 3 months after start of intervention, 6 months after start of intervention
description: The PMQ is a 24 item youth and parent report measure designed to assess parental monitoring and sources of parental knowledge. The monitoring subscale has demonstrated good reliability (alpha = .82 parents, .85 youth) and correlates with adolescent internalizing and externalizing maladjustment, deviant peer relationships, and family discord.
measure: McMaster Family Assessment Device
time frame: Baseline assessment, 3 months after start of intervention, 6 months after start of intervention
description: This measure includes the following sub-scales assessing parenting skills: Problem Solving (i.e., the family's ability to resolve problems in ways that maintain effective family functioning.); Family Roles (i.e., the extent to which tasks are clearly and equitably distributed among family members); Communication (i.e., the extent to which verbal messages between family members are clear); Affective Involvement (i.e., the extent to which family members are interested in and placed value on each other's activities); Affective Responsiveness (i.e., the extent to which family members experience appropriate affect in response to stimuli); Behavioral Control (i.e., the extent to which the family expresses and maintains standards for the behavior of its members). All items are rated on a 4-point scale and the sub-scales have adequate reliability.
measure: Parent-Adolescent Communication Scale
time frame: Baseline assessment, 3 months after start of intervention, 6 months after start of intervention
description: The PACS is a youth and parent report measure that assesses positive and negative aspects of general parent-teen communication and the content and process of parent-teen interactions. The two sub-scales have good reliability (alpha = .77 - .88) and have been shown to correlate with teen engagement in problem behavior.
measure: Parenting Self Efficacy
time frame: Baseline assessment, 3 months after start of intervention, 6 months after start of intervention
description: This 10-item scale assesses the degree of parents' confidence in implementing specific parenting skills.
measure: FAsTask Video Code
time frame: Baseline assessment, 3 months after start of intervention, 6 months after start of intervention
description: The FAsTask is a video-taped family problem solving task that will be used to provide an in-vivo assessment of parenting behaviors. We have limited the assessment to tasks that align with our primary aims. Specifically, parent-teen dyads will be prompted to spend 5 minutes on each of the following: 1) teen leads a discussion about a time without supervision and parents seek additional information (monitoring and listening); 2) parents lead a discussion on setting limits over the previous month (limit setting) and then communicate rules to the teen; 3) parents and teens problem solve around an issue; and 4) positive recognition when the parent praises the teen.
measure: Issues Checklist
time frame: Baseline assessment, 3 months after start of intervention, 6 months after start of intervention
description: This measure will work to decipher distressed families versus non distressed families and addressing and identifying the issues.
measure: Disruptive Behavior Disorder Rating Scale
time frame: Baseline assessment, 3 months after start of intervention, 6 months after start of intervention
description: The DBDRS which is comprised of the DSM symptom lists for ADHD, ODD, and CD. It uses a 4-point response scale completed by parents for questions regarding ADHD and ODD and a yes/no format for CD symptoms to assess behavior problems within the past month. The DBDRS has been shown to have excellent psychometric properties
measure: Child and Adolescent Services Assessment (CASA)
time frame: Baseline assessment, 3 months after start of intervention, 6 months after start of intervention
description: This is a semi structured interview for parents and teens/children to assess service utilization for emotional, behavioral, and substance use problems. It addresses a range of services including inpatient, emergency room services, residential treatment centers, detention centers, probation, foster home services, hospitalization, in-home services, family therapy and outpatient services. The teen will complete questions regarding services related to school including boarding school, therapeutic/behavioral school, school support and school professional services
measure: Working Alliance Inventory
time frame: 3 months after start of intervention.
description: The WAI is an 11-item measure in which parents are asked to rate their alliance with their therapists on a 7-point Likert scale. This measure examines factors such as having a collaborative approach to treatment, perceived expertise, trust, and establishing shared goals.
arm group label: Treatment As Usual (TAU)
arm group type: No Intervention
description: The TAU condition consists of the standard treatment elements offered to all Gateway (study site) patients, and will be received by patients in both the PW and the TAU-only condition. TAU services during the adolescent's treatment are typically eclectic and mainly entail meeting with the adolescent alone to provide support and psychoeducation, with occasional family therapy sessions. Medication management is offered as needed.
arm group label: Parenting Wisely (PW)
arm group type: Experimental
description: In addition to TAU services, the PW arm includes in-person sessions where parents complete computer-administered PW sessions, in-person session including therapist coaching to reinforce PW material and personalize treatment by applying PW skills to individual issues, and access to PW material remotely so parents can access information and skills from home as needed.
intervention type: Behavioral
intervention name: Parenting Wisely
description: PW is a self-administered, interactive, multimedia online program. Parents will complete computer-administered sessions during in-person appointments.The program comes with a parent workbook so that parents can gain additional exposure to and practice with the skills. The complete PW program takes from 3 to 5 hours to complete depending on the users' speed and depth of use. Parents will be given a login at enrollment so that they have the option to practice sessions or view any additional sessions at home. Individual coaching sessions will take place in-person with parents. Coaching sessions are designed to tailor the PW skills to each parent's presenting concerns.
arm group label: Parenting Wisely (PW)
other name: PW
criteria: 
gender: All
minimum age: 12 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jennifer Wolff, PhD
phone: 401-444-3790
email: jwolff2@lifespan.org
last name: Melanie Altemus, BA
email: MAltemus@lifespan.org
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Rhode Island Hospital
investigator full name: Jennifer Wolff
investigator title: Staff Psychologist
mesh term: Problem Behavior