Development of DBT/Parent Training Group Intervention

September 14, 2021 updated by: University of Oregon

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:

  1. 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.
  2. 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

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Oregon
      • Eugene, Oregon, United States, 97403
        • University of Oregon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 24, 2020

Primary Completion (Actual)

February 24, 2021

Study Completion (Actual)

February 24, 2021

Study Registration Dates

First Submitted

January 7, 2021

First Submitted That Met QC Criteria

February 1, 2021

First Posted (Actual)

February 5, 2021

Study Record Updates

Last Update Posted (Actual)

September 16, 2021

Last Update Submitted That Met QC Criteria

September 14, 2021

Last Verified

September 1, 2021

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)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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