Preschooler Emotion Regulation in the Context of Maternal Borderline Personality Disorder

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.

Study Overview

• Status: Completed
• Conditions: Borderline Personality Disorder; Emotional Problem
• Intervention / Treatment: Behavioral: Dialectical Behavior Therapy Skills

Detailed Description

Borderline personality disorder is a serious mental illness characterized by extreme emotions, chaotic interpersonal relationships, suicidal behaviors, and a poor sense of self. Offspring of mothers with Borderline Personality Disorder (BPD) are at an elevated risk for developing mental illness across the lifespan. Difficulty managing emotions are a hallmark feature of BPD, and yet the ability to do so is necessary for responding effectively to childrens' emotions. This process is called maternal emotion socialization, which has a major impact on how children develop their own emotion regulation (ER) skills. ER develops rapidly during preschool and deficits in preschool ER are recognized as underlying future mental disorders. This proposal will test a model examining the extent to which maternal ER and emotion socialization impact child ER, which may be a significant pathway by which mental health problems are transmitted to offspring of mothers with BPD. This proposal will leverage Dialectical Behavior Therapy (DBT) Skills training, a robust and effective method for improving ER as a tool to change maternal ER in mothers with BPD. By completing multiple assessments of biobehavioral markers of child and mother ER, this study is poised to uncover a potentially modifiable pathway by which these offspring are at risk. Specifically, the investigators propose to conduct a stratified randomized controlled trial of DBT Skills for mothers with BPD who have preschoolers. A total of 300 dyads (initial child age: 36-54 months) will be collected in Eugene, Oregon and Pittsburgh Pennsylvania, with 100 pairs in each of three groups: children who have mothers with BPD who receive DBT Skills, children who have mothers with BPD who receive Family Services as Usual, and children who have non-disordered mothers, matched on income, with this final group only participating in assessments (as to quantify normative ER growth). All children will be assessed 4 times every 2-months, with the first assessment occurring prior to treatment assignment. Investigators will use a biobehavioral laboratory battery to measure child ER, assessing emotion understanding, strategy use, attention regulation and inhibitory control, and parasympathetic regulation. In mothers, a similar multi-method approach to assess emotion acceptance, strategy use, recognition, and parasympathetic regulation will be employed. Finally, during each laboratory assessment, there will be observations of mother's ability to effectively respond to children in the context of child negative emotions. Growth curve modeling will chart child ER trajectories for all 3 groups so that investigators can compare child ER growth as a function of: group status (DBT Skills vs. Family Services as Usual vs. income matched, non-disordered controls), changes in maternal ER, and changes in maternal emotion socialization. Findings from this proposal will identify a modifiable pathway by which offspring of mothers with BPD are at risk, determine the extent to which child ER can be restored by treating mothers, and will be the first DBT Skills trial to measure outcomes in offspring.

• Study Type: Interventional
• Enrollment (Actual): 93
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dialectical Behavior Therapy Skills; Dialectical Behavior Therapy SKills; 2.5 hour group session/week; 1 year	Behavioral: Dialectical Behavior Therapy Skills; DBT Skills Training will follow the DBT Skills Training Manual Second Edition and the DBT Skills Training Handouts and Worksheets Second Edition.
No Intervention: Family Services as Usual; Mothers will continue with services they are receiving in the community

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal Emotion Dysregulation	Difficulties with Emotion Regulation Scale; Minimum score = 36, Maximum score = 180; higher scores indicate great difficulties with emotion regulation	1 year

Collaborators and Investigators

• Sponsor: University of Oregon
• Collaborators: University of Pittsburgh
• Investigators: Principal Investigator: Maureen Zalewski, Ph.D., University of Oregon; Principal Investigator: Stephanie Stepp, Ph.D., University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2017
• Primary Completion (Actual): May 4, 2022
• Study Completion (Actual): May 4, 2022

Study Registration Dates

• First Submitted: February 17, 2017
• First Submitted That Met QC Criteria: February 17, 2017
• First Posted (Actual): February 23, 2017

Study Record Updates

• Last Update Posted (Actual): January 12, 2024
• Last Update Submitted That Met QC Criteria: January 11, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Personality Disorders; Borderline Personality Disorder
• Other Study ID Numbers: R01MH111758 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: NIMH NDA
• IPD Sharing Time Frame: See NIMH NDA
• IPD Sharing Access Criteria: See NIMH NDA
• IPD Sharing Supporting Information Type: ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No