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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05287178
• Other study ID #: 00000041
• Status: Completed
• Phase: N/A
• Start date: July 12, 2021
• Est. completion date: August 22, 2022

Study information

• Verified date: March 2022
• Source: University of Oregon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: August 22, 2022
• Est. primary completion date: August 22, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Emotional Regulation
• Parenting
• Substance-Related Disorders

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	University of Oregon	Eugene	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
University of Oregon

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in DBT skill use	DBT Ways of Coping Checklist (DBT-WCCL). A 38-item self-report questionnaire which measures the frequency of DBT Skills use.	Baseline up to 22 weeks
Primary	Change in Parental Emotion Regulation	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, with higher scores indicating higher levels of dysregulation. The measure is comprised of six subscales: lack of emotional awareness, lack of emotional clarity, limited emotion regulation strategies, difficulties with impulse control, difficulties engaging in goal-directed behavior, and nonacceptance of emotional responses	Baseline up to 22 weeks
Primary	Change in Parenting Stress	Parenting Stress Index (PSI-4 SF; Abidin, 1995). 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. Normative scores have been established and raw scores are converted to T-scores and percentiles for interpretation.	Baseline up to 22 weeks
Primary	Change in Parenting Quality	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. It yields three subscales: laxness, over-reactivity and hostile parenting.	Baseline up to 22 weeks
Primary	Change in Parental Emotion Socialization	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: distress reactions, punitive reactions, minimization, expressive encouragement, emotion-focused reactions and problem-focused reactions. The first three can then be summed into an Invalidating/Unsupportive composite and the latter three can be summed into a Validating/Supportive composite.	Baseline up to 22 weeks
Primary	Client Satisfaction	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.	Post-intervention (22 week timepoint)
Secondary	Child Internalizing and Externalizing Behaviors	The Child Behavior Checklist (CBCL; Achenbach & Rescorla, 2000) is a 99-item parent-report ratings scale for children's problem behaviors which provide subscales for both internalizing (e.g. anxious, sad) and externalizing (e.g. hyperactive, aggressive) behaviors. Higher scores indicate greater problem behaviors and symptoms of psychopathology.	Baseline and Post-intervention (22 week timepoint)
Secondary	Changes in Child Behavior	The Weekly Assessment of Child Behavior (WACB, Forte et al., 2012) is a brief 9-item parent-report measure in which parents rate (on a Likert scale of 1-7) how often their child engages in positive behaviors on a weekly basis. The measure is based on the positive opposites of behaviors measured by the Eyberg Child Behavior Inventory (ECBI) and yields two scales: Intensity and Need-to-Change. The measure has demonstrated strong convergent validity with other established measures of child behavior problems.	Baseline up to 22 weeks
Secondary	Changes in Child Emotion Regulation	The Emotion Regulation Checklist (ERC; Shields & Cicchetti, 1997) is a 24-item parent-report measure in which parents rate (on a Likert scale of 1-4) how characteristic of their child are statements which focus on mood lability, lack of flexibility, dysregulated negative emotion, empathy, emotional self-awareness and positive response to others. The measure produces two subscales (lability/negativity and emotion regulation) and a composite of the two.	Baseline and Post-intervention (22 week timepoint)
Secondary	Parent Mental Health Symptoms: Anxiety	The Hamilton Anxiety Scale (HAM-A; Hamilton, 1969) is a 14-item self-report measure that assesses physical symptoms of anxiety. Subjects rate the severity of symptoms ranging from 0 (Not present) to 4 (Very Severe). Scores are summed for a total score ranging from 0 to 56, with higher scores indicating higher levels of anxiety.	Baseline and Post-intervention (22 week timepoint)
Secondary	Parent Mental Health Symptoms: Depression	The Patient Health Questionnaire - depression module (PHQ-9; Kroenke, Spitzer, & Williams, 2001) is a 9-item self-report questionnaire in which participants rate how often depressive symptoms have bothered them in the past 2 weeks on a scale of 0 (Not at all) to 3 (Nearly every day). Scores are summed for a total score ranging from 0 to 27 with higher scores indicating higher levels of depressed mood.	Baseline and Post-intervention (22 week timepoint)
Secondary	Parent Mental Health Symptoms: Substance Craving	The Aggregated Drug Craving Scale (ADCS; Costello et al., 2020) is an adaptation of the Penn Alcohol Craving Scale (PACS; Flannery et al., 1999) aimed at measuring a broad range of substance craving. The measure includes five items that assesses intensity, frequency, and duration of craving along with ability to resist substance use if it was available, and it asks responders to give an average craving rating for the past week. The response ranges from 0 to 6 for each item and higher scores indicate greater cravings.	Baseline and Post-intervention (22 week timepoint)
Secondary	Parent Mental Health Symptoms: Sustained Recovery from from SUD	Structured Clinical Interview for DSM-5 (SCID-5; First, Spitzer, Gibbon & Williams, 2015). The SCID-5 will be used as the diagnostic measure during the intake and in the exit interview to assess parents' potential substance use disorders. Substance use disorder modules will assess for current (past 12 months) and past (past 5 years) of the following DSM 5 defined disorders: alcohol, cannabis, hallucinogenic, inhalant, opioid, sedative/hypnotic/anxiolytic, and stimulant.	Baseline and Post-intervention (22 week timepoint)