Integration of DBT Skills and Parent Training for Parents With a History of Substance Use
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Parental Emotion Dysregulation - The Difficulties With Emotion Regulation Scale (DERS)
研究概览
简要总结
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:
- Determine feasibility, acceptability and implementation.
- Evaluate pre-post changes in measures of parental emotion dysregulation, parenting quality and children's mental health.
详细描述
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:
- 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.
- 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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
- •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.
结局指标
主要结局
Parental Emotion Dysregulation - The Difficulties With Emotion Regulation Scale (DERS)
时间窗: Baseline and post-intervention (22 week timepoint)
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.
Parenting Stress - Parenting Stress Index Short Form
时间窗: Baseline and post-intervention (22 week timepoint)
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.
Parenting Quality (Total Dysfunctional Discipline) - The Parenting Scale
时间窗: Baseline and post-intervention (22 week timepoint)
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.
Implementation of Skills
时间窗: Baseline up to 22 weeks
Weekly avg. number of DBT and parenting skills used daily
Acceptability (Client Satisfaction) - Client Satisfaction Questionnaire (CSQ-8)
时间窗: 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.
Feasibility of Intervention (Attendance)
时间窗: Post-intervention (20 week timepoint)
Average number of sessions attended
Parental Emotion Socialization (Non-supportive Parenting) - Coping With Children's Negative Emotions Scale (CCNES)
时间窗: Baseline and post-intervention (22 week timepoint)
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.
Feasibility of Intervention (Attrition)
时间窗: Post-intervention (20 week timepoint)
Attrition rate was measured as percentage of participants who discontinued treatment.
次要结局
- 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: Substance Craving(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))