Adolescent - Emotional Problem, Mental Disorder in Adolescence, Parenting
Conditions
Brief summary
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).
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.
Interventions
BEHAVIORALParenting Wisely Residential Treatment (PWRT)
PWRT experimental intervention
BEHAVIORALTAU
The TAU condition is the standard of care offered to parents in RT settings.
Sponsors
Ohio State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
Participants will not know which group they are assigned to, however, study staff will know.
Eligibility
Sex/Gender
ALL
Age
11 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Group Attendance (Feasibility) | Mean calculated at 6-weeks post-baseline | The mean number of groups attended by parent participants in the PWRT arm. |
| Group Duration (Feasibility) | Mean calculated at 6-weeks post-baseline | The mean amount of time parent participants spent in a single session of the group. |
| Module Duration (Feasibility) | Mean calculated at 6-weeks post-baseline | The mean time parent participants spent completing one module in Parenting Wisely. |
| Module Completion | 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
| Measure | Time frame | Description |
|---|---|---|
| Brief Problem Monitor (BPM) - Internalizing Behaviors | 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. |
| Brief Problem Monitor (BPM) - Externalizing Behaviors | 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. |
| Brief Problem Monitor (BPM) - Total Score | 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. |
Countries
United States
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Customized Age, Adolescents | 15.4 years STANDARD_DEVIATION 1.7 |
| Age, Customized Age, Parents | 45.1 years STANDARD_DEVIATION 7.9 |
| Race/Ethnicity, Customized Hispanic /Latinx No | 67 Participants |
| Race/Ethnicity, Customized Hispanic /Latinx Yes-Mexican | 1 Participants |
| Race/Ethnicity, Customized Hispanic /Latinx Yes-Puerto Rican/Cuban/Other | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 26 Participants |
| Region of Enrollment United States | 4 participants |
| Relationship to child in treatment Aunt | 2 Participants |
| Relationship to child in treatment Father | 1 Participants |
| Relationship to child in treatment Foster parent | 0 Participants |
| Relationship to child in treatment Grandfather | 0 Participants |
| Relationship to child in treatment Grandmother | 4 Participants |
| Relationship to child in treatment Mother | 40 Participants |
| Relationship to child in treatment Other | 5 Participants |
| Relationship to child in treatment Stepfather | 0 Participants |
| Relationship to child in treatment Stepmother | 2 Participants |
| Relationship to child in treatment Uncle | 0 Participants |
| Sex/Gender, Customized Female | 4 Participants |
| Sex/Gender, Customized Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 32 | 0 / 32 | 0 / 1 | 0 / 4 |
| other Total, other adverse events | 0 / 32 | 0 / 32 | 0 / 1 | 0 / 4 |
| serious Total, serious adverse events | 0 / 32 | 0 / 32 | 0 / 1 | 0 / 4 |
Outcome results
None listed