Optimizing Residential Treatment Gains for Adolescents

Parenting Clinical Trial

Official title:

Optimizing Residential Treatment Gains for Adolescents Through Tailored Behavioral Parent Training

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05764369
• Other study ID #: 2022B0315
• Status: Recruiting
• Phase: N/A
• Start date: August 31, 2023
• Est. completion date: November 30, 2025

Study information

• Verified date: February 2024
• Source: Ohio State University
• Contact: Kayla Herbel, PhD, RN
• Phone: 614-688-0959
• Email: herbell.3[@]osu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this randomized controlled trial is to determine the feasibility, acceptability, and preliminary effects of a web-based parent training (Parenting Wisely) augmented with facilitated parent groups (referred to as PWRT). 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: November 30, 2025
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 11 Years and older

Eligibility

Parent Inclusion Criteria:

• Caregiver (e.g., biological, step, kin, foster, adoptive) to an adolescent aged 11-17 years old who is 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

Related Conditions & MeSH terms

• Adolescent - Emotional Problem
• Mental Disorder in Adolescence
• Mental Disorders
• Parenting

Intervention

Behavioral:
• Parenting Wisely Residential Treatment (PWRT)
PWRT experimental intervention
• TAU
The TAU condition is the standard of care offered to parents in RT settings.

Locations

Country	Name	City	State
United States	Ohio State University College of Nursing	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Group attendance frequency (Feasibility)	Group attendance is tracked and an average attendance rate across all sessions will be calculated	Average calculated from baseline to 6-weeks post-baseline
Primary	Parenting Wisely login frequency (Feasibility)	The number of logins to Parenting Wisely is tracked and an average logins across all sessions will be calculated	Average calculated from baseline to 6-weeks post-baseline
Primary	Dose of PWRT (Feasibility)	The number of modules in Parenting Wisely that are completed are tracked and an average completion rate across all sessions will be calculated	Average calculated from baseline to 6-weeks post-baseline
Primary	Duration of PW modules (Feasibility)	The time spent completing modules in Parenting Wisely are tracked and an average duration rate across all sessions will be calculated	Average calculated from baseline to 6-weeks post-baseline
Primary	Duration of group (Feasibility)	The time spent in group is tracked and an average duration rate across all sessions will be calculated	Average calculated from baseline to 6-weeks post-baseline
Primary	PWRT Acceptability	Parents will complete an investigator-developed 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.	6-weeks post-baseline
Secondary	Change in Adolescent Internalizing Behaviors	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.	Change from baseline to 6-months post-baseline
Secondary	Change in Adolescent Internalizing Behaviors	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.	Change from baseline to 6-weeks post-baseline
Secondary	Change in Adolescent Externalizing Behaviors	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.	Change from baseline to 6-weeks post-baseline
Secondary	Change in Adolescent Externalizing Behaviors	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.	Change from baseline to 6-months post-baseline
Secondary	Change in Restrictiveness of Living Environment	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.	Change from baseline to 6-weeks post-baseline
Secondary	Change in Restrictiveness of Living Environment	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.	Change from baseline to 6-months post-baseline
Secondary	Change in Family Function	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.	Change from baseline to 6-weeks post-baseline
Secondary	Change in Family Function	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.	Change from baseline to 6-months post-baseline
Secondary	Change in Social Support	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.	Change from baseline to 6-weeks post-baseline
Secondary	Change in Social Support	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.	Change from baseline to 6-months post-baseline
Secondary	Change in Parenting Practices	The Adult-Adolescent Parenting Inventory (AAPI) will be administered to parents to evaluate changes in parenting practices. The AAPI consists of 40-items and is designed for parents of adolescents aged 12 to 17. The AAPI assesses parenting and rearing attitudes and practices. Total scores range from 40-200; higher scores indicate more effective parenting practices.	Change from baseline to 6-weeks post-baseline
Secondary	Change in Parenting Practices	The Adult-Adolescent Parenting Inventory (AAPI) will be administered to parents to evaluate changes in parenting practices. The AAPI consists of 40-items and is designed for parents of adolescents aged 12 to 17. The AAPI assesses parenting and rearing attitudes and practices. Total scores range from 40-200; higher scores indicate more effective parenting practices.	Change from baseline to 6-months post-baseline
Secondary	Change in Parenting Self Efficacy	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.	Change from baseline to 6-weeks post-baseline
Secondary	Change in Parenting Self Efficacy	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.	Change from baseline to 6-months post-baseline