Trial Outcomes & Findings for Preschooler Emotion Regulation in the Context of Maternal Borderline Personality Disorder (NCT NCT03060902)

NCT ID: NCT03060902

Last Updated: 2024-01-12

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 93 participants
• Primary outcome timeframe: 1 year
• Results posted on: 2024-01-12

Participant Flow

Participant milestones

Measure	Dialectical Behavior Therapy Skills Dialectical Behavior Therapy SKills; 2.5 hour group session/week; 1 year 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.	Family Services as Usual Mothers will continue with services they are receiving in the community
Overall Study STARTED	46	47
Overall Study COMPLETED	23	47
Overall Study NOT COMPLETED	23	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Preschooler Emotion Regulation in the Context of Maternal Borderline Personality Disorder

Baseline characteristics by cohort

Measure	Dialectical Behavior Therapy Skills n=46 Participants Dialectical Behavior Therapy SKills; 2.5 hour group session/week; 1 year 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.	Family Services as Usual n=47 Participants Mothers will continue with services they are receiving in the community	Total n=93 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	46 Participants n=5 Participants	47 Participants n=7 Participants	93 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	46 Participants n=5 Participants	47 Participants n=7 Participants	93 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants	12 Participants n=7 Participants	19 Participants n=5 Participants
Race (NIH/OMB) White	34 Participants n=5 Participants	28 Participants n=7 Participants	62 Participants n=5 Participants
Race (NIH/OMB) More than one race	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	46 participants n=5 Participants	47 participants n=7 Participants	93 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Population: 37 DBT randomized participants completed the final time point and 40 Family Services as Usual participants completed the final time point.

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

Outcome measures

Measure	Dialectical Behavior Therapy Skills n=37 Participants Dialectical Behavior Therapy SKills; 2.5 hour group session/week; 1 year 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.	Family Services as Usual n=40 Participants Mothers will continue with services they are receiving in the community
Maternal Emotion Dysregulation	82.35 score on a scale Standard Deviation 21.37	91.8 score on a scale Standard Deviation 25.45

Adverse Events

Dialectical Behavior Therapy Skills

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Family Services as Usual

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Maureen Zalewski

University of Oregon

Phone: 541-346-7073

Email: zalewski@uoregon.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place