- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05764369
Optimizing Residential Treatment Gains for Adolescents
Optimizing Residential Treatment Gains for Adolescents Through Tailored Behavioral Parent Training
Study Overview
Status
Intervention / Treatment
Detailed Description
A randomized controlled trial (RCT) design is employed to evaluate the feasibility, acceptability, engagement of target mechanisms, and preliminary effects of PWRT in parents with adolescents transitioning from residential treatment (RT) to the community. Parents (n=60) will be randomly assigned to receive Parenting Wisely augmented with facilitated discussion groups (referred to as PWRT; n=30) or treatment-as-usual (TAU; n=30). In the PWRT condition, parents will complete 2 web-based modules in an online parent training program called Parenting Wisely. Parents will also attend a 90-minute discussion group via Zoom. The RCT will allow for testing of target mechanism engagement (i.e., parental self-efficacy, parenting behaviors, social support, family function) and the intervention's effects on adolescent outcomes (i.e., internalizing behaviors, externalizing behaviors, placement restrictiveness). Parents will complete assessments at baseline (T1), six weeks post-baseline (T2), and six months post-baseline (T3) via REDCap. While adolescents (n=60) will not directly receive the intervention, they will complete assessments at baseline, six weeks post-baseline (T2), and six months post-baseline (T3).
Aim 1: Evaluate the feasibility and acceptability of PWRT. 1a. Evaluate the feasibility of PWRT by tracking the frequency, dose, and duration. 1b. Evaluate the acceptability of PWRT for parents with adolescents in RT.
Aim 2: Determine the effects of PWRT on the target mechanisms compared to the TAU condition from baseline to 6-weeks and 6-months post-baseline.
Aim 3: Determine the effects of PWRT on adolescent outcomes compared to the TAU condition from baseline to 6-weeks and 6-months post-baseline. 3a. Determine if changes in the target mechanisms are associated with adolescent outcomes at six weeks and six months post-baseline.
Exploratory Aim: Explore the feasibility of collecting data from adolescents in an RT facility by tracking frequency (recruitment, enrollment, retention rates), duration (time between parent consent and assent; survey duration), and barriers to data collection.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ohio
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Columbus, Ohio, United States, 43210
- Ohio State University College of Nursing
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Parent Inclusion Criteria:
- Caregiver (e.g., biological, step, kin, foster, adoptive) to an adolescent aged 11-17 years old admitted to psychiatric residential treatment;
- The caregiver is allowed contact with the adolescent;
- Has access to a device (e.g., smartphone) with internet access.
Adolescent Inclusion Criteria:
- Ability to understand and willingness to provide written assent
- Legal guardian provides written consent;
- Currently or previously admitted to psychiatric residential treatment
- Aged 11-17 years at enrollment;
Parent and Adolescent Exclusion Criteria:
- Not able to speak English
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Parenting Wisely Residential Treatment (PWRT) - Parents
In the PWRT condition, parents will complete a total of ten web-based modules in an online parent training program called Parenting Wisely.
Each week, parents will also attend a 90-minute facilitated discussion group via Zoom.
Parents will complete assessments at baseline (T1), six weeks post-baseline (T2), and six months post-baseline (T3) via REDCap.
While adolescents (n=60) will not directly receive the intervention, they will complete assessments at baseline, six weeks post-baseline (T2), and six months post-baseline (T3).This arm includes only parent respondents.
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PWRT experimental intervention
Other Names:
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Placebo Comparator: Treatment as Usual (TAU) - Parents
The TAU condition is the standard of care offered to parents in RT settings.
Parents in the TAU condition will receive traditional programming, including family therapy offered weekly during the RT admission.
Parents will attend discharge planning meetings with caseworkers (if assigned) to discuss the adolescent's progress, continued treatment needs, safety plans, upcoming appointments, and medication needs.
Following discharge, programs frequently recommend follow-up with an outpatient provider for medication management and therapy for the adolescent.
Parents will complete assessments at baseline (T1), six weeks post-baseline (T2), and six months post-baseline (T3) via REDCap.
While adolescents (n=60) will not directly receive the intervention, they will complete assessments at baseline, six weeks post-baseline (T2), and six months post-baseline (T3).
This arm includes only parent respondents.
|
The TAU condition is the standard of care offered to parents in RT settings.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Group Attendance (Feasibility)
Time Frame: Mean calculated at 6-weeks post-baseline
|
The mean number of groups attended by parent participants in the PWRT arm.
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Mean calculated at 6-weeks post-baseline
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Group Duration (Feasibility)
Time Frame: Mean calculated at 6-weeks post-baseline
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The mean amount of time parent participants spent in a single session of the group.
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Mean calculated at 6-weeks post-baseline
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Module Duration (Feasibility)
Time Frame: Mean calculated at 6-weeks post-baseline
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The mean time parent participants spent completing one module in Parenting Wisely.
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Mean calculated at 6-weeks post-baseline
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Module Completion
Time Frame: Mean calculated at 6-weeks post-baseline
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Average number of modules parent participants completed over a 6 week intervention period The mean number of Modules participants completed in Parenting Wisely. |
Mean calculated at 6-weeks post-baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Brief Problem Monitor (BPM) - Internalizing Behaviors
Time Frame: Baseline, 6 weeks, 6 months; Change from baseline to 6 weeks; Change from baseline to 6-months post
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Adolescent internalizing behaviors will be assessed using the Brief Problem Monitor (BPM) for ages 6 to 18. There are two subscales on the BPM: internalizing and externalizing subscales. There are six items on the internalizing subscale with scores ranging from 0-12. Higher scores indicate greater internalizing behaviors, therefore worse outcomes. Change over time in the outcome measure is assessed by subtracting mean values at T1 from mean values at T2 and T3 respectively. |
Baseline, 6 weeks, 6 months; Change from baseline to 6 weeks; Change from baseline to 6-months post
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Brief Problem Monitor (BPM) - Externalizing Behaviors
Time Frame: Baseline, 6 weeks, 6 months; Change from baseline to 6 weeks; Change from baseline to 6-months post
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Adolescent externalizing behaviors will be assessed using the Brief Problem Monitor (BPM) for ages 6 to 18. There are two subscales on the BPM: internalizing and externalizing subscales. There are seven items on the externalizing subscale with scores ranging from 0-14. Higher scores indicate greater externalizing behaviors, therefore worse outcomes. Change over time in the outcome measure is assessed by subtracting mean values at T1 from mean values at T2 and T3 respectively. |
Baseline, 6 weeks, 6 months; Change from baseline to 6 weeks; Change from baseline to 6-months post
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Brief Problem Monitor (BPM) - Total Score
Time Frame: Baseline, 6 weeks, 6 months; Change from baseline to 6 weeks; Change from baseline to 6-months post
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Total adolescent behavior problems will be assessed using the Brief Problem Monitor (BPM) for ages 6 to 18.
The BPM consists of 19 items derived from the Child Behavior Checklist.
The total score includes internalizing, externalizing and inattention subscales which are summed.
Internalizing behaviors is 6 items with scores ranging from 0-12, Externalizing is 7 items with scores ranging from 0-14, Inattention is 6 items with scores ranging from 0-12.
Raw scores range from 0-38; higher scores indicate greater total behavior problems thereby worse outcomes.
Change over time in the outcome measure is assessed by subtracting mean values at T1 from mean values at T2 and T3 respectively.
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Baseline, 6 weeks, 6 months; Change from baseline to 6 weeks; Change from baseline to 6-months post
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022B0315
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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