AzTrials
AzTrials

Borderline Personality DisorderNCT03060902

Preschooler Emotion Regulation in the Context of Maternal Borderline Personality Disorder

A study testing Dialectical Behavior Therapy Skills in people with Borderline Personality Disorder and Emotional Problem, run by University of Oregon at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years, women only
What is being tested?
Dialectical Behavior Therapy Skills
Could I receive a placebo?
No, everyone receives an active treatment
How many people
93 participants
Where
1 siteUnited States
Study dates
23 Oct 2017to 4 May 2022
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

Other trials in United States

About this study

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.

Read the 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.

Being tested
Dialectical Behavior Therapy Skills
Medical subject headings
Borderline Personality Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dialectical Behavior Therapy SkillsBehavioural

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

Study groups in NCT03060902
Study groupRoleWhat they receive
Dialectical Behavior Therapy SkillsExperimentalDialectical Behavior Therapy SKills; 2.5 hour group session/week; 1 year
Receives: Behavioral: Dialectical Behavior Therapy Skills
Family Services as UsualNo interventionMothers will continue with services they are receiving in the community

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maternal Emotion Dysregulation

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

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Feb 2017
  2. Study start23 Oct 2017
  3. Primary completion4 May 2022
  4. Study completion4 May 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
93 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03060902
Sponsor's protocol ID
R01MH111758
Status last verified
Jan 2024
First submitted
17 Feb 2017
Last updated
12 Jan 2024
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: NIMH NDA

Questions about this trial

What is this clinical trial studying?

A study testing Dialectical Behavior Therapy Skills in people with Borderline Personality Disorder and Emotional Problem, run by University of Oregon at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maternal Emotion Dysregulation (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2024.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in