Integration of DBT Skills and Parent Training for Parents With a History of Substance Use

Parenting Clinical Trial

Official title: Integration of DBT Skills and Parent Training for Parents With a History of Substance Use

Status Completed

Clinical Trial Summary

This treatment development study is aimed at developing and pilot testing a 20-week remotely delivered group intervention that integrates two evidence-based treatments: 1) Dialectical Behavior Therapy (DBT) Skills - targeting parental emotion dysregulation and substance use, and 2) Parent Training (PT) - targeting parenting behaviors linked to children's mental health. The case study will provide preliminary data on the feasibility of the DBT Skills +PT intervention and its engagement of the targeted outcomes, and aims to complete foundational steps necessary to conducting a future, larger scale randomized controlled trial. Specific aims are to: 1. Determine feasibility, acceptability and implementation. 2. Evaluate pre-post and weekly changes in measures of parental emotion regulation, parenting stress, parenting quality and children's mental health.

Clinical Trial Description

Overview This treatment development study is aimed at developing and pilot testing a 20-week remotely delivered group intervention that integrates two evidence-based treatments: 1) Dialectical Behavior Therapy (DBT) Skills - targeting parental emotion dysregulation and substance use, and 2) Parent Training (PT) - targeting parenting behaviors linked to children's mental health. The case study will provide preliminary data on the feasibility of the DBT Skills +PT intervention and its engagement of the targeted outcomes, and aims to complete foundational steps necessary to conducting a future, larger scale randomized controlled trial. Specific aims are to: 1. Determine feasibility, acceptability and implementation. Feasibility of recruitment (number of participants meeting eligibility on the initial online screener and number meeting eligibility following intake), feasibility of measurement tools (time taken to complete online questionnaires, missing data from questionnaires) and feasibility of the intervention (number of sessions attended by parents) will all be assessed to determine overall feasibility of the intervention study. Acceptability will be evaluated using measures of client satisfaction and a qualitative exit interview with each parent post-intervention. Implementation will be assessed by examining the frequency with which clients use DBT and parenting skills and by tracking clients' weekly skills use via a diary card. 2. Evaluate pre-post and weekly changes in measures of parental emotion regulation, parenting stress, parenting quality and children's mental health using a Single Case Experimental Design (SCED). Across 12 parents (two groups with ~6 parents in each group), we will evaluate the rate and pattern of change in these interlinked domains which represent risk factors for relapse and further adverse outcomes. We anticipate pre-post changes (2 time points, approximately 20-22 weeks apart) will be comparable to well-established change scores from the clinical trial literature base for DBT Skills and parent training interventions. Additionally, qualitative data from exit interviews with each parent will be analyzed using thematic analyses of responses to evaluate parents' perceptions of changes in their own mental health, their parenting and their children's behavior over the course of the intervention. Weekly repeated measures (20 time points) will allow us to model the rate and pattern of change from week to week. As the intervention is divided into 4 modules, change patterns will also be examined between modules. Data will be presented descriptively and we expect changes to unfold in a cascading order, with increased use of skills preceding reductions in parent emotion dysregulation, followed by improvements in parenting quality and subsequent improvements in child behavior. The study will be conducted remotely and involves five phases: 1) an online screener questionnaire; 2) a clinical diagnostic intake interview to formally determine eligibility; 3) an online pre-intervention assessment survey; 4) 20 weeks of DBT Skills +PT group therapy and 20 weekly online assessment surveys; 5) an online post-intervention assessment survey and an exit interview. All online screeners and assessments will be completed using Qualtrics. The clinical diagnostic intake interview, weekly DBT Skills +PT sessions and exit interviews will all be conducted over a HIPAA compliant version of Zoom. Assignment of Participants to Condition All participating parents will be assigned to the DBT Skills +PT condition. Up to 12 parents will be enrolled in the DBT Skills +PT group therapy. As the intervention is scheduled for 20 weeks, families will be recruited twice throughout the year to facilitate running 2 groups (6 participants in each). Data Analysis Results from this case study to pilot test the integrated DBT Skills +PT intervention will be descriptive. For Aim 1, feasibility of recruitment will be examined via the number of participants meeting eligibility on the initial online screener as compared to the number of participants meeting eligibility following the clinical intake. Feasibility of measurement tools will be assessed by calculating the average time taken by participants to complete the online Qualtrics questionnaires, and the average percentage of missing data from the online questionnaires. Feasibility of the intervention will be evaluated by calculating the average number of sessions attended by parents. Acceptability will be examined by averaging the total scores obtained from the Client Satisfaction Questionnaire (CSQ-8). In addition, using qualitative thematic analyses, we will report on data collected during the exit interview, identifying overall themes about the intervention that emerge from parents' comments. We will examine implementation by calculating the average daily number of DBT and parenting skills parents report using each week on their diary card (averaged across parents) and comparing these to skill use reported in other published research. We will primarily report data for Aim 1 at an aggregated group level. We may also include de-identified information at the individual level in the form of quotes from parents' exit interviews. For Aim 2, we will examine pre-post changes for primary and secondary outcomes - DBT Skill use, emotion dysregulation, parenting stress, parenting quality, child internalizing and externalizing behaviors, child emotion regulation, and parent mental health symptoms. Pre-post change scores will be compared to the clinical trial literature base for DBT and parent training interventions which often use the same measures and for which expected change scores are established. Additionally, based on post-intervention reports during the SCID 5 diagnostic interview, the percentage of parents reporting sustained recovery (vs relapse) from substance use disorder will be calculated and reported. We will examine change across time based on data available in the weekly assessment measures of parents' skill use, parents' emotion dysregulation, parenting quality, and children's symptoms and behaviors. Consistent with common practice in case study designs, we will primarily use visual inspection (i.e. evaluating graphical displays of participants' weekly scores) to examine the data collected during Weeks 1-20 of the DBT Skills +PT intervention. We will inspect several aspects of these data, such as changes in the trajectories of each measure, to determine the direction and extent of change in the measured symptoms and behaviors from week to week, and the timing of when those changes occurred. These visual inspection analyses will be conducted at both the individual level and at an aggregated group level. Weekly measures will enable us to identify rates and patterns of change over the course of the intervention. We expect these changes to unfold in a cascading order, with increased use of skills preceding reductions in parent emotion dysregulation, followed by improvements in parenting quality and subsequent improvements in child behavior. ;

Related Conditions & MeSH terms

• Emotional Regulation
• Parenting
• Substance-Related Disorders

• NCT number: NCT05287178
• Study type: Interventional
• Source: University of Oregon
• Status: Completed
• Phase: N/A
• Start date: July 12, 2021
• Completion date: August 22, 2022