Preschooler Emotion Regulation in the Context of Maternal Borderline Personality Disorder
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15213
- University of Pittsburgh Medical Center
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Dialectical Behavior Therapy Skills
Dialectical Behavior Therapy SKills; 2.5 hour group session/week; 1 year
|
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
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Maternal Emotion Dysregulation
Time Frame: 1 year
|
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
Sponsor
Collaborators
Collaborators
Investigators
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)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- R01MH111758 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- ICF
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.
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