ParentingNCT05287178
Integration of DBT Skills and Parent Training for Parents With a History of Substance Use
A study testing DBT Skills + Parent Training in people with Parenting and Substance Abuse Relapse, run by University of Oregon at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parenting, Substance Abuse Relapse, Emotional Regulation
- What is being tested?
- DBT Skills + Parent Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jul 2021to 22 Aug 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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:
- 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).
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.
- Conditions
- Parenting, Substance Abuse Relapse, Emotional Regulation
- Being tested
- DBT Skills + Parent Training
- Medical subject headings
- Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DBT Skills + Parent TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: DBT Skills + Parent Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Post-intervention (22 week timepoint)
Feasibility of Intervention (Attendance)
Average number of sessions attended
Measured: Post-intervention (20 week timepoint)
Feasibility of Intervention (Attrition)
Attrition rate was measured as percentage of participants who discontinued treatment.
Measured: Post-intervention (20 week timepoint)
Implementation of Skills
Weekly avg. number of DBT and parenting skills used daily
Measured: Baseline up to 22 weeks
Secondary outcomes (5)
Child Externalizing Behaviors - Child Behavior Checklist (CBCL)
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.
Measured: Baseline and Post-intervention (22 week timepoint)
Child Emotion Dysregulation - Emotion Regulation Checklist (Lability/Negativity Subscale)
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.
Measured: Baseline and Post-intervention (22 week timepoint)
Parent Mental Health Symptoms: Anxiety - Hamilton Anxiety Scale (HAM-A)
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.
Measured: Baseline and Post-intervention (22 week timepoint)
Parent Mental Health Symptoms: Depression - Patient Health Questionnaire Depression Module (PHQ-9)
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.
Measured: Baseline and Post-intervention (22 week timepoint)
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 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.
Measured: Baseline and Post-intervention (22 week timepoint)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2022
- Study start12 Jul 2021
- Primary completion22 Aug 2022
- Study completion22 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ParentingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oregon
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05287178
- Sponsor's protocol ID
- 00000041
- Other IDs
- P50DA048756
- Status last verified
- Mar 2022
- First submitted
- 9 Mar 2022
- Last updated
- 11 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integration of DBT Skills and Parent Training for Parents With a History of Substance Use
- ClinicalTrials.gov ID
- NCT05287178
- Acronym / sponsor ID
- 00000041
- Conditions
- Parenting, Substance Abuse Relapse, Emotional Regulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of OregonUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 12 Jul 2021 (actual)
- Primary completion
- 22 Aug 2022 (actual)
- Study completion
- 22 Aug 2022 (actual)
- First posted
- 18 Mar 2022 (actual)
- Results
- Posted 11 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DBT Skills + Parent Training | Experimental | Behavioral: DBT Skills + Parent TrainingThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DBT Skills + Parent TrainingThe 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. | Behavioural | DBT Skills + Parent Training |
Primary outcome
Parental Emotion Dysregulation - The Difficulties With Emotion Regulation Scale (DERS)
Time frame: 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
Time frame: 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
Time frame: 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.
Parental Emotion Socialization (Non-supportive Parenting) - Coping With Children's Negative Emotions Scale (CCNES)
Time frame: 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.
Acceptability (Client Satisfaction) - Client Satisfaction Questionnaire (CSQ-8)
Time frame: 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)
Time frame: Post-intervention (20 week timepoint)
Average number of sessions attended
Feasibility of Intervention (Attrition)
Time frame: Post-intervention (20 week timepoint)
Attrition rate was measured as percentage of participants who discontinued treatment.
Implementation of Skills
Time frame: Baseline up to 22 weeks
Weekly avg. number of DBT and parenting skills used daily
5 secondary outcomes
Child Externalizing Behaviors - Child Behavior Checklist (CBCL)
Time frame: Baseline and Post-intervention (22 week timepoint)
Child Emotion Dysregulation - Emotion Regulation Checklist (Lability/Negativity Subscale)
Time frame: Baseline and Post-intervention (22 week timepoint)
Parent Mental Health Symptoms: Anxiety - Hamilton Anxiety Scale (HAM-A)
Time frame: Baseline and Post-intervention (22 week timepoint)
Parent Mental Health Symptoms: Depression - Patient Health Questionnaire Depression Module (PHQ-9)
Time frame: Baseline and Post-intervention (22 week timepoint)
Parent Mental Health Symptoms: Substance Craving
Time frame: Baseline and Post-intervention (22 week timepoint)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DBT Skills + Parent Training in people with Parenting and Substance Abuse Relapse, run by University of Oregon at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parental Emotion Dysregulation - The Difficulties With Emotion Regulation Scale (DERS) (time frame: Baseline and post-intervention (22 week timepoint)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2024.