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

NCT05287178 | Completed Results

• 2 other identifiers: 00000041P50DA048756
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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. 1.Determine feasibility, acceptability and implementation.
2. 2.Evaluate pre-post changes in measures of parental emotion dysregulation, parenting quality and children's mental health.

Conditions

Parenting; Substance Abuse Relapse; Emotional Regulation

Outcome Measures

Primary Outcomes (8)

• Parental Emotion Dysregulation - The Difficulties With Emotion Regulation Scale (DERS)

  The Difficulties with Emotion Regulation Scale (DERS; Gratz \& Roemer, 2004) is a 36-item self-report measure used to assess adult emotion dysregulation. Items are rated on a scale of 1 to 5, and total scores range from 36 to 180, with higher scores indicating higher levels of dysregulation.

  Baseline and post-intervention (22 week timepoint)

• Parenting Stress - Parenting Stress Index Short Form

  The Parenting Stress Index Short Form (PSI-4 SF; Abidin, 1995) is a 36-item parent report measure of parental stress (rated on a five point Likert scale), and includes three subscales: Parental Distress, Parent-Child Dysfunctional Interaction, and Difficult Child. Raw Subscale scores are summed into a Total Stress score that ranges from 36 to 180, with higher scores indicating higher levels of parenting stress. Normative scores have been established and raw scores are then converted to percentiles for interpretation.

  Baseline and post-intervention (22 week timepoint)

• Parenting Quality (Total Dysfunctional Discipline) - The Parenting Scale

  The Parenting Scale (PS; Arnold et al., 1993) is a 30-item self-report questionnaire, in which parents are asked to describe (on a Likert scale of 1-7) how they respond to a variety of child misbehaviors. In addition to three sub scales (laxness, over-reactivity and hostile parenting), it yields a total dysfunctional discipline score, which is calculated by averaging responses on all items. Total scores can thus range from 1 to 7, with higher scores reflecting greater dysfunctional discipline.

  Baseline and post-intervention (22 week timepoint)

• Parental Emotion Socialization (Non-supportive Parenting) - Coping With Children's Negative Emotions Scale (CCNES)

  The Coping with Children's Negative Emotions Scale (CCNES; Fabes, Eisenberg \& Bernzweig, 1990) assesses parental self-report of emotion socialization practices. Parents are presented with 12 vignettes describing scenarios in which their children exhibit distress. Parents rate (on a Likert scale of 1-7) the likelihood they would engage in 6 potential parental responses to these situations, with each corresponding to 6 subscales which are each mean-scored: distress reactions, punitive reactions, minimization, expressive encouragement, emotion-focused reactions and problem-focused reactions. The first three can then be summed and mean-scored into an Invalidating/non-supportive composite and the latter three can be summed and mean-scored into a Validating/Supportive composite. Scores for the composites range from 1 to 7 with higher scores indicating higher levels of non-supportive or supportive parenting.

  Baseline and post-intervention (22 week timepoint)

• Acceptability (Client Satisfaction) - Client Satisfaction Questionnaire (CSQ-8)

  The Client Satisfaction Questionnaire (CSQ-8; Attkisson \& Zwick, 1982) will be used to assess acceptability of the intervention. It is a brief 8-item self-report measure in which clients are asked to rate (on a Likert scale of 1-4) their satisfaction with the intervention. Scores range from 8 to 32 with higher scores indicating greater satisfaction.

  Post-intervention (22 week timepoint)

• Feasibility of Intervention (Attendance)

  Average number of sessions attended

  Post-intervention (20 week timepoint)

• Feasibility of Intervention (Attrition)

  Attrition rate was measured as percentage of participants who discontinued treatment.

  Post-intervention (20 week timepoint)

• Implementation of Skills

  Weekly avg. number of DBT and parenting skills used daily

  Baseline up to 22 weeks

Secondary Outcomes (5)

• Child Externalizing Behaviors - Child Behavior Checklist (CBCL)

  Baseline and Post-intervention (22 week timepoint)

• Child Emotion Dysregulation - Emotion Regulation Checklist (Lability/Negativity Subscale)

  Baseline and Post-intervention (22 week timepoint)

• Parent Mental Health Symptoms: Anxiety - Hamilton Anxiety Scale (HAM-A)

  Baseline and Post-intervention (22 week timepoint)

• Parent Mental Health Symptoms: Depression - Patient Health Questionnaire Depression Module (PHQ-9)

  Baseline and Post-intervention (22 week timepoint)

• Parent Mental Health Symptoms: Substance Craving

  Baseline and Post-intervention (22 week timepoint)

Study Arms (1)

DBT Skills + Parent Training

EXPERIMENTAL

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.

Behavioral: DBT Skills + Parent Training

Interventions

DBT Skills + Parent Training 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.

DBT Skills + Parent Training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Oregon: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Oregon

Eugene, Oregon, 97403, United States

Location

MeSH Terms

Conditions

Emotional Regulation

Condition Hierarchy (Ancestors)

Self-Control; Social Behavior; Behavior

Results Point of Contact

• Title: Yoel Everett
• Organization: University of Oregon

yeverett@uoregon.edu

541-346-7054

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2022
• First Posted: March 18, 2022
• Study Start: July 12, 2021
• Primary Completion: August 22, 2022
• Study Completion: August 22, 2022
• Last Updated: July 11, 2024
• Results First Posted: July 11, 2024

Record last verified: 2022-03

Locations

US (1)