- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04740138
Development of DBT/Parent Training Group Intervention
This treatment development study is aimed at developing and pilot testing a 24-week remotely delivered group intervention that integrates three evidence-based treatments: 1) Dialectical Behavior Therapy (DBT) Skills - targeting adult emotion dysregulation, 2) Parent Management Training (PMT) - targeting parenting behaviors linked to child behavioral dysregulation, and 3) Emotion Coaching (EC) - targeting parental emotion socialization practices linked to child emotion dysregulation.
The aims of the study are to:
- Evaluate the feasibility of the intervention, specifically with respect to its acceptability and its implementation with 4 families in which a parent has elevated levels of emotion dysregulation and their child has elevated levels of emotion or behavioral dysregulation.
- Examine change patterns in parent and child mental health and parenting quality using a Single Case Experimental Design (SCED) to evaluate both pre-post and weekly changes in these outcomes.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Oregon
-
Eugene, Oregon, United States, 97403
- University of Oregon
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- parent must be 18+ years of age
- parent must have at least partial custody of a 3-6 year old child
- neither parent nor child may have any known developmental disability
- parent must be proficient in English
- parent must endorse elevated emotion dysregulation and report their child meets a cutoff for emotional and/or behavioral difficulties.
- parent must have access to the internet and Zoom software
Exclusion Criteria:
- parent with developmental disability
- psychotic disorder
- actively suicidal with an active plan
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: DBT Skills + Parent Training
|
The DBT/Parent training group intervention is a novel integration of three evidence-based treatments (i.e. DBT Skills, Parent Management Training (PMT), and Emotion Coaching (EC)). The DBT Skills portion of each session follows the DBT Skills Training Manual Second Edition and DBT Skills Training Handouts and Worksheets Second Edition. DBT Skills portions cover the four modules of traditional DBT Skills: mindfulness, distress tolerance, emotion regulation and interpersonal effectiveness. PMT portions of the intervention cover: praise, positive interactions and parental attention, reward systems, effective commands, use of consequences, and problem solving. EC portions of the intervention cover: psychoeducation on children's emotional development, teaching children to identify and label emotions, validation of children's emotions, handling children's negative emotions, fostering children's positive emotions and parental modeling of emotion regulation and expression. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in parental emotion dysregulation
Time Frame: Baseline up to 24 weeks
|
Difficulties with Emotion Regulation Scale (DERS).
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 24 weeks
|
|
Change in child behavior
Time Frame: Baseline up to 24 weeks
|
Strengths and Difficulties Questionnaire (SDQ).
A 25-item parent-report measure in which parents rate (on a Likert scale of 0-2) how characteristic of their child are emotional and behavioral strengths and difficulties.
The measure yields a total difficulties score as well as subscales for emotional symptoms, conduct problems, hyperactivity, peer problems and prosocial behavior.
Internalizing and Externalizing sub scales can also be generated.
Higher scores indicate greater difficulties.
|
Baseline up to 24 weeks
|
|
Change in parenting Quality
Time Frame: Baseline up to 24 weeks
|
Parenting Scale (PS).
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.
The measure yields three subscales: laxness, over-reactivity and hostile parenting.
Higher scores indicate more dysfunctional parenting behaviors.
|
Baseline up to 24 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 11192019.028
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Parenting
-
Johns Hopkins UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development...Recruiting
-
Tampere University HospitalTampere UniversityCompletedParenting Satisfaction | Parenting Self-efficacyFinland
-
Johns Hopkins UniversityThe Rita and Alex Hillman Foundation; Abell Foundation; Richman Foundation; Sherman... and other collaboratorsRecruitingParenting | Parenting InterventionUnited States
-
University of TurkuRecruiting
-
University of MinnesotaArizona State UniversityCompleted
-
WestatMakerere UniversityCompleted
-
Central Hospital, Nancy, FranceCompleted
-
Yale UniversityCompleted
-
Ministry of Health, KuwaitActive, not recruitingChild Development | Child Mental Health | Parenting Intervention | Parenting BehaviorKuwait
Clinical Trials on Dialectical Behavioral Therapy Skills + Parent Training
-
Duke UniversityCompleted
-
Duke UniversityNational Cancer Institute (NCI)CompletedCancer Metastatic to LungUnited States
-
Fundació Institut de Recerca de l'Hospital de la...EMDR EuropeRecruiting
-
Medical University of South CarolinaNational Cancer Institute (NCI); National Institutes of Health (NIH)Not yet recruiting
-
Rutgers, The State University of New JerseyCompletedEmotional Regulation | AffectUnited States
-
University of Massachusetts, AmherstNational Institute of Mental Health (NIMH); University of ToledoCompletedBorderline Personality DisorderUnited States
-
Medical University of South CarolinaAmerican Cancer Society, Inc.Not yet recruitingSurvivorship
-
Centre for Addiction and Mental HealthUniversity of Missouri, St. LouisCompletedSubstance Use Disorders | Alcohol Use DisorderCanada
-
University of Maryland, BaltimoreRecruitingSuicide | PsychosisUnited States
-
Emory UniversityCompleted