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

NCT ID: NCT05287178

Last Updated: 2024-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-12
• Study Completion Date: 2022-08-22

Brief 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 changes in measures of parental emotion dysregulation, parenting quality and children's mental health.

Detailed 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. Number of sessions attended by parents and attrition rates will be assessed to determine overall feasibility of the intervention. Acceptability will be evaluated using measures of client satisfaction. Implementation will be assessed by examining the frequency with which clients report using DBT and parenting skills.

2. Evaluate pre-post changes in measures of parental emotion dysregulation, parenting quality and children's mental health. Across 12 parents (three groups with ~4 parents in each group), we will evaluate the 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.

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; 5) an online post-intervention assessment survey. 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 3 groups (~4 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 the intervention will be evaluated by calculating the average number of sessions attended by parents and attrition rates. Acceptability will be examined by averaging the total scores obtained from the Client Satisfaction Questionnaire (CSQ-8). 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.

For Aim 2, we will examine pre-post changes for primary and secondary outcomes - parental emotion dysregulation, 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.

Conditions

Parenting; Substance Abuse Relapse; Emotional Regulation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

DBT Skills + Parent Training

The DBT Skills +PT group intervention integrates DBT Skills, Parent Management Training (PMT), and Emotion Coaching (EC). Each session includes a mindfulness practice, homework review to discuss use of skills previously learned, didactics to learn a new set of DBT and PT skills, and assignment of homework. The DBT Skills portions cover the four modules of traditional DBT Skills: Mindfulness, Emotion Regulation, Distress Tolerance (including skills specifically focused on managing difficulties with addiction), and Interpersonal Effectiveness. PT skills include both PMT and EC components such as: praise, use of parental attention to reward positive behavior, reward systems, effective commands and consequences, psychoeducation on children's emotional development, teaching children to label emotions, validating children's emotions, and handling children's negative emotions, and fostering positive emotions.

Group Type: EXPERIMENTAL

DBT Skills + Parent Training

Intervention Type: BEHAVIORAL

The DBT Skills +PT group intervention integrates DBT Skills, Parent Management Training (PMT), and Emotion Coaching (EC). Each session includes a mindfulness practice, homework review to discuss use of skills previously learned, didactics to learn a new set of DBT and PT skills, and assignment of homework. The DBT Skills portions cover the four modules of traditional DBT Skills: Mindfulness, Emotion Regulation, Distress Tolerance (including skills specifically focused on managing difficulties with addiction), and Interpersonal Effectiveness. PT skills include both PMT and EC components such as: praise, use of parental attention to reward positive behavior, reward systems, effective commands and consequences, psychoeducation on children's emotional development, teaching children to label emotions, validating children's emotions, and handling children's negative emotions, and fostering positive emotions.

Interventions

DBT Skills + Parent Training

The DBT Skills +PT group intervention integrates DBT Skills, Parent Management Training (PMT), and Emotion Coaching (EC). Each session includes a mindfulness practice, homework review to discuss use of skills previously learned, didactics to learn a new set of DBT and PT skills, and assignment of homework. The DBT Skills portions cover the four modules of traditional DBT Skills: Mindfulness, Emotion Regulation, Distress Tolerance (including skills specifically focused on managing difficulties with addiction), and Interpersonal Effectiveness. PT skills include both PMT and EC components such as: praise, use of parental attention to reward positive behavior, reward systems, effective commands and consequences, psychoeducation on children's emotional development, teaching children to label emotions, validating children's emotions, and handling children's negative emotions, and fostering positive emotions.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

Participants must reside in Oregon.

Participants must have at least partial custody of a preschool-aged child (3-6 years)

Participants must present elevated levels of emotion dysregulation on the Difficulties with Emotion Regulation Scale (DERS) (a score of >88, equivalent to +.5 SD above a normative score) on the online screener.

Participants must endorse 2 or more positive answers on adapted version of the CAGE-AID screener for drug and alcohol problems, which asks about substance use in the past 5 years.

Participants must meet diagnostic criteria for a past (past 5 years) but not current (past 12 months) substance use disorder (SUD) from the following DSM 5 defined disorders: alcohol, cannabis, hallucinogenic, inhalant, opioid, sedative/hypnotic/anxiolytic, and stimulant.

Participants must be proficient in English.

Participants must have the internet access needed to participate in an online remote telehealth intervention.

Exclusion Criteria

Participants will be excluded if they or their child have a known developmental disability or if during the clinical intake parents are determined to have a low IQ score (IQ<70) on the PPVT-V.

Participants will be excluded if they are psychotic as determined by the SCID 5.

Participants will be excluded if they are actively manic or psychotic as determined by clinical observation.

Participants will be excluded if they are actively suicidal with an active plan as determined by the SCID 5 and/or Patient Health Questionnaire 9 (PHQ-9).

Participants will be excluded if they are determined by clinical judgment to be at high risk of violence towards others.

Participants may be excluded if clinical judgment suggests they requires a higher level or different form of care.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

University of Oregon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Oregon

Eugene, Oregon, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

P50DA048756

Identifier Type: NIH

Identifier Source: secondary_id

View Link

00000041

Identifier Type: -

Identifier Source: org_study_id