Clinical trial NCT05287178: Integration of DBT Skills and Parent Training for Parents With a History of Substance Use
Official title: Integration of DBT Skills and Parent Training for Parents With a History of Substance Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parenting
Substance Abuse Relapse
Emotional Regulation
Lead sponsor: University of Oregon
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2022-03-18
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Parental Emotion Dysregulation - The Difficulties With Emotion Regulation Scale (DERS)
timeFrame: Baseline and post-intervention (22 week timepoint)
measure: Parenting Stress - Parenting Stress Index Short Form
timeFrame: Baseline and post-intervention (22 week timepoint)
measure: Parenting Quality (Total Dysfunctional Discipline) - The Parenting Scale
timeFrame: Baseline and post-intervention (22 week timepoint)
measure: Parental Emotion Socialization (Non-supportive Parenting) - Coping With Children's Negative Emotions Scale (CCNES)
timeFrame: Baseline and post-intervention (22 week timepoint)
measure: Acceptability (Client Satisfaction) - Client Satisfaction Questionnaire (CSQ-8)
timeFrame: Post-intervention (22 week timepoint)
measure: Feasibility of Intervention (Attendance)
timeFrame: Post-intervention (20 week timepoint)
measure: Feasibility of Intervention (Attrition)
timeFrame: Post-intervention (20 week timepoint)
measure: Implementation of Skills
timeFrame: Baseline up to 22 weeks
Secondary outcomes:
measure: Child Externalizing Behaviors - Child Behavior Checklist (CBCL)
timeFrame: Baseline and Post-intervention (22 week timepoint)
measure: Child Emotion Dysregulation - Emotion Regulation Checklist (Lability/Negativity Subscale)
timeFrame: Baseline and Post-intervention (22 week timepoint)
measure: Parent Mental Health Symptoms: Anxiety - Hamilton Anxiety Scale (HAM-A)
timeFrame: Baseline and Post-intervention (22 week timepoint)
measure: Parent Mental Health Symptoms: Depression - Patient Health Questionnaire Depression Module (PHQ-9)
timeFrame: Baseline and Post-intervention (22 week timepoint)
measure: Parent Mental Health Symptoms: Substance Craving
timeFrame: Baseline and Post-intervention (22 week timepoint)
Other outcomes:
Locations:
city: Eugene
country: United States
facility: University of Oregon
state: Oregon
Study officials:
References: