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Completed

NCT Number: NCT05764369

Optimizing Residential Treatment Gains for Adolescents

The goal of this randomized controlled trial is to determine the feasibility, acceptability, and preliminary effects of a web-based parent training augmented with facilitated parent groups. This hybrid group-based parenting program (called Parenting Wisely for Residential Treatment; PWRT) is designed to prepare parents for the reintegration of their adolescents in the home after intensive psychiatric residential treatment. Researchers will compare PWRT to treatment as usual to determine whether PWRT effects target mechanisms (i.e., family function, social support, parental self-efficacy, parenting practices) and adolescent outcomes (i.e., internalizing and externalizing behaviors, placement restrictiveness).

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Key information

Age range

11 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ohio State University College of Nursing

Columbus, Ohio, 43210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Parenting Wisely Residential Treatment (PWRT)

Behavioral

PWRT experimental intervention

Other names: Parenting Wisely, PW

TAU

Behavioral

The TAU condition is the standard of care offered to parents in RT settings.

Primary outcomes

  1. 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.

  2. Group Duration (Feasibility)

    Time frame: Mean calculated at 6-weeks post-baseline

    The mean amount of time parent participants spent in a single session of the group.

  3. Module Duration (Feasibility)

    Time frame: Mean calculated at 6-weeks post-baseline

    The mean time parent participants spent completing one module in Parenting Wisely.

  4. Module Completion

    Time frame: Mean calculated at 6-weeks post-baseline

    Average number of modules parent participants completed over a 6 week intervention period

    The mean number of Modules participants completed in Parenting Wisely.

Secondary outcomes

  1. 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

    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.

  2. 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

    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.

  3. 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

    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.

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Registry information

Official study title

Optimizing Residential Treatment Gains for Adolescents Through Tailored Behavioral Parent Training

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 10, 2023
Registry last updated
Aug 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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