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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 participants.

  2. Module Completion (Feasibility)

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

    The mean number of modules completed by participants in Parenting Wisely.

  3. Module Duration (Feasibility)

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

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

  4. Group Duration (Feasibility)

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

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

  5. PWRT Acceptability

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

    Participants will complete a satisfaction survey to evaluate the acceptability of PWRT. The satisfaction survey consists of 13-items. Total scores range from 0-39; higher scores indicate greater perceptions of acceptability.

Secondary outcomes

  1. Change in Adolescent Internalizing Behaviors

    Time frame: Change from baseline to 6-months post-baseline

    Adolescent internalizing behaviors 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 subscales include internalizing, externalizing, and attention subscales. Raw scores range from 0-38; higher scores indicate greater internalizing behaviors.

  2. Change in Adolescent Internalizing Behaviors

    Time frame: Change from baseline to 6-weeks post-baseline

    Adolescent internalizing behaviors 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 subscales include internalizing, externalizing, and attention subscales. Raw scores range from 0-38; higher scores indicate greater internalizing behaviors.

  3. Change in Adolescent Externalizing Behaviors

    Time frame: Change from baseline to 6-weeks post-baseline

    Adolescent externalizing behaviors 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 subscales include internalizing, externalizing, and attention subscales. Raw scores range from 0-38; higher scores indicate greater externalizing behaviors.

  4. Change in Adolescent Externalizing Behaviors

    Time frame: Change from baseline to 6-months post-baseline

    Adolescent externalizing behaviors 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 subscales include internalizing, externalizing, and attention subscales. Raw scores range from 0-38; higher scores indicate greater externalizing behaviors.

  5. Change in Restrictiveness of Living Environment

    Time frame: Change from baseline to 6-weeks post-baseline

    The Restrictiveness Evaluation Measure (REM) will be administered to evaluate perceptions of adolescent placement restrictiveness. The REM was designed and tested in residential treatment settings. There are two subscales; one scale identifies 25 placement settings varying in restrictiveness and the second subscale consists of questions about the activity and lifestyle restrictions in such placements. Total scores range from 24-120; higher scores indicate more restrictive living environments.

  6. Change in Restrictiveness of Living Environment

    Time frame: Change from baseline to 6-months post-baseline

    The Restrictiveness Evaluation Measure (REM) will be administered to parents and adolescents to evaluate perceptions of adolescent placement restrictiveness. The REM was designed and tested in residential treatment settings. There are two subscales; one scale identifies 25 placement settings varying in restrictiveness and the second subscale consists of questions about the activity and lifestyle restrictions in such placements. Total scores range from 24-120; higher scores indicate more restrictive living environments.

  7. Change in Family Function

    Time frame: Change from baseline to 6-weeks post-baseline

    The McMaster Family Assessment Device (FAD) will be administered to parents to evaluate changes in family function. The FAD consists of 60-items that assess seven domains of family function: problem-solving, family roles, communication, affective involvement, affective responsiveness, behavioral control, general functioning. Total scores range from 60-240; higher scores indicate better family function.

  8. Change in Family Function

    Time frame: Change from baseline to 6-months post-baseline

    The McMaster Family Assessment Device (FAD) will be administered to parents to evaluate changes in family function. The FAD consists of 60-items that assess seven domains of family function: problem-solving, family roles, communication, affective involvement, affective responsiveness, behavioral control, general functioning. Total scores range from 60-240; higher scores indicate better family function.

  9. Change in Social Support

    Time frame: Change from baseline to 6-weeks post-baseline

    The Medical Outcomes Study (MOS) Social Support Survey will be administered to parents to evaluate changes in social support. The MOS consists of 19-items that assess five social support domains: emotional support, informational support, tangible support, affectionate support, and positive social interaction. Total scores range from 20-100; higher scores indicate greater social support.

  10. Change in Social Support

    Time frame: Change from baseline to 6-months post-baseline

    The Medical Outcomes Study (MOS) Social Support Survey will be administered to parents to evaluate changes in social support. The MOS consists of 19-items that assess five social support domains: emotional support, informational support, tangible support, affectionate support, and positive social interaction.Total scores range from 20-100; higher scores indicate greater social support.

  11. Change in Parenting Self Efficacy

    Time frame: Change from baseline to 6-weeks post-baseline

    Parents will complete the Parenting Sense of Competence Scale (PSOC) to evaluate changes in parental self-efficacy. The PSOC consists of 17-items and is designed for parents with children aged birth to 17. The two subscales in the PSOC are satisfaction and efficacy. Total scores range from 17-102; higher scores indicate greater perceptions of self-efficacy and confidence.

  12. Change in Parenting Self Efficacy

    Time frame: Change from baseline to 6-months post-baseline

    Parents will complete the Parenting Sense of Competence Scale (PSOC) to evaluate changes in parental self-efficacy. The PSOC consists of 17-items and is designed for parents with children aged birth to 17. The two subscales in the PSOC are satisfaction and efficacy. Total scores range from 17-102; higher scores indicate greater perceptions of self-efficacy and confidence.

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
Jul 4, 2025

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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