Trial Outcomes & Findings for Integration of DBT Skills and Parent Training for Parents With a History of Substance Use (NCT NCT05287178)

NCT ID: NCT05287178

Last Updated: 2024-07-11

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 12 participants
• Primary outcome timeframe: Baseline and post-intervention (22 week timepoint)
• Results posted on: 2024-07-11

Participant Flow

Parents were recruited via a variety of methods (e.g. university departmental database; social media; Craigslist; community mental health referrals; direct mailing through Early Head Start). Parents were recruited multiple times throughout the year to facilitate running three groups. Group 1 sessions ran from July until December 2021. Groups 2 and 3 ran from March 2022 until August 2022.

Of 17 participants who consented, 13 met eligibility criteria. One chose not to participate and 12 were enrolled in the DBT Skills + Parent Training intervention.

Participant milestones

Measure	DBT Skills + Parent Training The DBT Skills +PT group intervention integrates DBT Skills, Parent Management Training (PMT), and Emotion Coaching (EC).
Overall Study STARTED	12
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	DBT Skills + Parent Training The DBT Skills +PT group intervention integrates DBT Skills, Parent Management Training (PMT), and Emotion Coaching (EC).
Overall Study Lost to Follow-up	2

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	DBT Skills + Parent Training n=12 Participants The DBT Skills +PT group intervention integrates DBT Skills, Parent Management Training (PMT), and Emotion Coaching (EC).
Age, Continuous	33.75 years STANDARD_DEVIATION 6.08 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants
Race (NIH/OMB) More than one race	4 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants
Difficulties with Emotion Regulation Scale (DERS)	109.50 units on a scale STANDARD_DEVIATION 13.33 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline and post-intervention (22 week timepoint)

Population: 2 participants lost to post-intervention follow-up.

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.

Outcome measures

Measure	DBT Skills + Parent Training n=12 Participants The DBT Skills +PT group intervention integrates DBT Skills, Parent Management Training (PMT), and Emotion Coaching (EC).
Parental Emotion Dysregulation - The Difficulties With Emotion Regulation Scale (DERS) Baseline	109.50 units on a scale Standard Deviation 13.33
Parental Emotion Dysregulation - The Difficulties With Emotion Regulation Scale (DERS) Post-intervention	68.80 units on a scale Standard Deviation 28.88

PRIMARY outcome

Timeframe: Baseline and post-intervention (22 week timepoint)

Population: 2 participants lost to post-intervention follow-up

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.

Outcome measures

Measure	DBT Skills + Parent Training n=12 Participants The DBT Skills +PT group intervention integrates DBT Skills, Parent Management Training (PMT), and Emotion Coaching (EC).
Parenting Stress - Parenting Stress Index Short Form Baseline	68.92 percentile Standard Deviation 16.71
Parenting Stress - Parenting Stress Index Short Form Post-intervention	48.00 percentile Standard Deviation 24.33

PRIMARY outcome

Timeframe: Baseline and post-intervention (22 week timepoint)

Population: 2 participants lost to post-intervention follow up

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.

Outcome measures

Measure	DBT Skills + Parent Training n=12 Participants The DBT Skills +PT group intervention integrates DBT Skills, Parent Management Training (PMT), and Emotion Coaching (EC).
Parenting Quality (Total Dysfunctional Discipline) - The Parenting Scale Baseline	3.62 score on a scale Standard Deviation .51
Parenting Quality (Total Dysfunctional Discipline) - The Parenting Scale Post-intervention	2.75 score on a scale Standard Deviation .81

PRIMARY outcome

Timeframe: Baseline and post-intervention (22 week timepoint)

Population: 2 participants were lost to follow up/post-intervention assessment

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.

Outcome measures

Measure	DBT Skills + Parent Training n=12 Participants The DBT Skills +PT group intervention integrates DBT Skills, Parent Management Training (PMT), and Emotion Coaching (EC).
Parental Emotion Socialization (Non-supportive Parenting) - Coping With Children's Negative Emotions Scale (CCNES) Baseline	2.43 score on a scale Standard Deviation .62
Parental Emotion Socialization (Non-supportive Parenting) - Coping With Children's Negative Emotions Scale (CCNES) Post-intervention	2.16 score on a scale Standard Deviation .60

PRIMARY outcome

Timeframe: Post-intervention (22 week timepoint)

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.

Outcome measures

Measure	DBT Skills + Parent Training n=8 Participants The DBT Skills +PT group intervention integrates DBT Skills, Parent Management Training (PMT), and Emotion Coaching (EC).
Acceptability (Client Satisfaction) - Client Satisfaction Questionnaire (CSQ-8)	30.75 score on a scale Standard Deviation 2.82

PRIMARY outcome

Timeframe: Post-intervention (20 week timepoint)

Population: Treatment completers

Average number of sessions attended

Outcome measures

Measure	DBT Skills + Parent Training n=8 Participants The DBT Skills +PT group intervention integrates DBT Skills, Parent Management Training (PMT), and Emotion Coaching (EC).
Feasibility of Intervention (Attendance)	86.25 percentage of sessions attended Standard Deviation 15.75

PRIMARY outcome

Timeframe: Post-intervention (20 week timepoint)

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

Outcome measures

Measure	DBT Skills + Parent Training n=12 Participants The DBT Skills +PT group intervention integrates DBT Skills, Parent Management Training (PMT), and Emotion Coaching (EC).
Feasibility of Intervention (Attrition)	4 Participants

PRIMARY outcome

Timeframe: Baseline up to 22 weeks

Population: Treatment completers who completed weekly daily diaries on skill use

Weekly avg. number of DBT and parenting skills used daily

Outcome measures

Measure	DBT Skills + Parent Training n=7 Participants The DBT Skills +PT group intervention integrates DBT Skills, Parent Management Training (PMT), and Emotion Coaching (EC).
Implementation of Skills DBT Skills in non-parenting contexts	2.56 number of skills used daily Standard Deviation 2.32
Implementation of Skills DBT Skills in parenting contexts	1.53 number of skills used daily Standard Deviation 1.85
Implementation of Skills Parent Training skills	4.03 number of skills used daily Standard Deviation 3.65

SECONDARY outcome

Timeframe: Baseline and Post-intervention (22 week timepoint)

The Child Behavior Checklist (CBCL; Achenbach & Rescorla, 2000) is a 99-item parent-report ratings scale (items are rated from 0-2) for children's problem behaviors. The scale provide subscales for both internalizing (e.g. anxious, sad) and externalizing (e.g. hyperactive, aggressive) behaviors. Normative scores have been established and total summed raw scores are converted to T-scores and percentiles for interpretation. T-scores range from 28 to 100, with a population mean of 50 and a standard deviation of 10. Higher T-scores indicate greater problem behaviors and symptoms of psychopathology.

Outcome measures

Measure	DBT Skills + Parent Training n=10 Participants The DBT Skills +PT group intervention integrates DBT Skills, Parent Management Training (PMT), and Emotion Coaching (EC).
Child Externalizing Behaviors - Child Behavior Checklist (CBCL) Baseline	53.00 T-score Standard Deviation 9.87
Child Externalizing Behaviors - Child Behavior Checklist (CBCL) Post-intervention	44.90 T-score Standard Deviation 10.71

SECONDARY outcome

Timeframe: Baseline and Post-intervention (22 week timepoint)

Population: 2 participants lost to follow up/post-intervention assessment

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. Items are summed to produce produce two subscales (lability/negativity and emotion regulation). The negativity/lability subscale ranges from 15 to 60 with higher scores indicating higher levels of emotional lability/negativity.

Outcome measures

Measure	DBT Skills + Parent Training n=12 Participants The DBT Skills +PT group intervention integrates DBT Skills, Parent Management Training (PMT), and Emotion Coaching (EC).
Child Emotion Dysregulation - Emotion Regulation Checklist (Lability/Negativity Subscale) Baseline	25.33 score on a scale Standard Deviation 3.96
Child Emotion Dysregulation - Emotion Regulation Checklist (Lability/Negativity Subscale) Post-intervention	22.20 score on a scale Standard Deviation 4.98

SECONDARY outcome

Timeframe: Baseline and Post-intervention (22 week timepoint)

Population: 2 participants lost to follow up/post intervention assessment

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.

Outcome measures

Measure	DBT Skills + Parent Training n=12 Participants The DBT Skills +PT group intervention integrates DBT Skills, Parent Management Training (PMT), and Emotion Coaching (EC).
Parent Mental Health Symptoms: Anxiety - Hamilton Anxiety Scale (HAM-A) Baseline	19.33 score on a scale Standard Deviation 11.29
Parent Mental Health Symptoms: Anxiety - Hamilton Anxiety Scale (HAM-A) Post-intervention	10.90 score on a scale Standard Deviation 5.78

SECONDARY outcome

Timeframe: Baseline and Post-intervention (22 week timepoint)

Population: 2 participants lost to follow up/post-intervention assessment

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.

Outcome measures

Measure	DBT Skills + Parent Training n=12 Participants The DBT Skills +PT group intervention integrates DBT Skills, Parent Management Training (PMT), and Emotion Coaching (EC).
Parent Mental Health Symptoms: Depression - Patient Health Questionnaire Depression Module (PHQ-9) Baseline	10.42 score on a scale Standard Deviation 6.58
Parent Mental Health Symptoms: Depression - Patient Health Questionnaire Depression Module (PHQ-9) Post-intervention	4.70 score on a scale Standard Deviation 2.58

SECONDARY outcome

Timeframe: Baseline and Post-intervention (22 week timepoint)

Population: 2 participants lost to follow up/post-intervention assessment

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 assess 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. Responses are summed to provide a total score ranging from 0 to 30, and higher scores indicate greater cravings.

Outcome measures

Measure	DBT Skills + Parent Training n=12 Participants The DBT Skills +PT group intervention integrates DBT Skills, Parent Management Training (PMT), and Emotion Coaching (EC).
Parent Mental Health Symptoms: Substance Craving Baseline	9.42 score on a scale Standard Deviation 6.17
Parent Mental Health Symptoms: Substance Craving Post-intervention	7.40 score on a scale Standard Deviation 6.69

Adverse Events

DBT Skills + Parent Training

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Yoel Everett

University of Oregon

Phone: 541-346-7054

Email: yeverett@uoregon.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place