Preschooler Emotion Regulation in the Context of Maternal Borderline Personality Disorder

NCT03060902 | Completed Results DMC

• 1 other identifier: R01MH111758
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

Brief Summary

Offspring of mothers with Borderline Personality Disorder (BPD) are at serious risk for developing mental illness at every stage of their life, and yet little is known about how this risk is transmitted. This study will leverage Dialectical Behavior Therapy Skills as an experimental intervention to determine if preschool emotion regulation develops more rapidly as a result of improvements in mothers' ability to regulate her own emotions. The knowledge from this study will identify a modifiable pathway by which maternal BPD places offspring at risk for later mental disorders and will quantify how much improvement in children's ability to regulate their emotions can be achieved by treating mothers alone.

Conditions

Borderline Personality Disorder; Emotional Problem

Outcome Measures

Primary Outcomes (1)

• Maternal Emotion Dysregulation

  Difficulties with Emotion Regulation Scale; Minimum score = 36, Maximum score = 180; higher scores indicate great difficulties with emotion regulation

  1 year

Study Arms (2)

Dialectical Behavior Therapy Skills

EXPERIMENTAL

Dialectical Behavior Therapy SKills; 2.5 hour group session/week; 1 year

Behavioral: Dialectical Behavior Therapy Skills

Family Services as Usual

NO INTERVENTION

Mothers will continue with services they are receiving in the community

Interventions

Dialectical Behavior Therapy Skills BEHAVIORAL

DBT Skills Training will follow the DBT Skills Training Manual Second Edition and the DBT Skills Training Handouts and Worksheets Second Edition.

Dialectical Behavior Therapy Skills

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: The study requires participants be mothers.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have a child who is 3 years old; have custody of child; endorse at least 3 symptom criteria of BPD in which one symptom must be affective instability and uncontrollable anger; have a verbal IQ of at least 70

You may not qualify if:

• Does not have custody of child; child has known developmental disabilities; mother is psychotic; mother has suicidal ideation + an active plan; mother has low verbal IQ

Sponsors & Collaborators

• University of Oregon: lead
• University of Pittsburgh: collaborator

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Borderline Personality Disorder

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders

Results Point of Contact

• Title: Maureen Zalewski
• Organization: University of Oregon

zalewski@uoregon.edu

541-346-7073

Study Officials

• Maureen Zalewski, Ph.D.

  University of Oregon

  PRINCIPAL INVESTIGATOR

• Stephanie Stepp, Ph.D.

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 17, 2017
• First Posted: February 23, 2017
• Study Start: October 23, 2017
• Primary Completion: May 4, 2022
• Study Completion: May 4, 2022
• Last Updated: January 12, 2024
• Results First Posted: January 12, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• Time Frame: See NIMH NDA
• Access Criteria: See NIMH NDA

Locations

US (1)