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Preschooler Emotion Regulation in the Context of Maternal Borderline Personality Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03060902
Recruitment Status : Recruiting
First Posted : February 23, 2017
Last Update Posted : October 26, 2017
University of Pittsburgh
Information provided by (Responsible Party):
Maureen Zalewksi, University of Oregon

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.

Condition or disease Intervention/treatment Phase
Borderline Personality Disorder Emotional Problem Behavioral: Dialectical Behavior Therapy Skills Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Preschooler Emotion Regulation in the Context of Maternal Borderline Personality Disorder
Actual Study Start Date : October 23, 2017
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Maternal emotion dysregulation [ Time Frame: 1 year ]
    Difficulties with Emotion Regulation Scale

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   The study requires participants be mothers.
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03060902

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Contact: Maureen Zalewski, Ph.D. 5413467053

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United States, Pennsylvania
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Stephanie Stepp, Ph.D.         
Sponsors and Collaborators
University of Oregon
University of Pittsburgh
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Principal Investigator: Maureen Zalewski, Ph.D. University of Oregon
Principal Investigator: Stephanie Stepp, Ph.D. University of Pittsburgh

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Responsible Party: Maureen Zalewksi, Assistant Professor, University of Oregon Identifier: NCT03060902     History of Changes
Other Study ID Numbers: R01MH111758 ( U.S. NIH Grant/Contract )
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Personality Disorders
Borderline Personality Disorder
Pathologic Processes
Mental Disorders