Parenting Skills for Mothers With Borderline Personality Disorder (BPD)

NCT ID: NCT04169048

Last Updated: 2020-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-04

Study Completion Date

2023-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The first disorder-specific parenting training program for mothers with Borderline Personality Disorder (M-BPD) is evaluated in a randomized controlled trial.

The training program is expected to have positive effects on parenting behavior, decrease the risk of maltreatment of the child, and improve emotion regulation in mothers at post treatment and at 6-month follow-up compared to a control group (treatment as usual; TAU).

Additionally, disorder-specific aspects of dysfunctional parenting behavior as well as BPD-specific aspects of child maltreatment are compared to a clinical control group (mothers with anxiety and/or depression, M-AD/D) and a healthy control group (M-CON).

To assess the differential development of parenting, the risk of maltreatment and emotion dysregulation in untreated M-BPD are compared to M-CON. The investigators expect the difference to increase over time, indicating a worsening in BPD parenting.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Borderline Personality Disorder Mothers

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized controlled trial with intervention group and waiting group (treatment as usual)
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention group (BPD)

Participants (N=60) receive the weekly conducted intervention (group training for mothers with BPD) over the period of 12 weeks (12 sessions). Assessments of each participant: T0 (pre-intervention), T1 (post-intervention) and follow-up (6 months after T1).

Group Type EXPERIMENTAL

Group training for mothers with Borderline Personality Disorder

Intervention Type BEHAVIORAL

The group programme is designed to teach mothers with BPD parenting skills and to reduce dysfunctional parenting attitudes and strategies. The components are: childrens basics needs, mindfulness, stress and stress reduction, dealing with conflicts, dealing with emotions, dysfunctional attitudes, physical contact, parenting rules, self care.

waiting control group (BPD)

Members of this group (N=60) receive no intervention but treatment as usual (TAU). After completing all assessment points (T0, T1, T2), they can receive the intervention of the intervention group (group training).

Group Type NO_INTERVENTION

No interventions assigned to this group

clinical control group (AD/MDD)

Mothers with anxiety and/or depression (N=60) receive no intervention. Assessment point only T0.

Group Type NO_INTERVENTION

No interventions assigned to this group

healthy control group

Mothers with no actual mental disorder (N=60) receive no intervention.# Assessment points T0, T1, T2.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Group training for mothers with Borderline Personality Disorder

The group programme is designed to teach mothers with BPD parenting skills and to reduce dysfunctional parenting attitudes and strategies. The components are: childrens basics needs, mindfulness, stress and stress reduction, dealing with conflicts, dealing with emotions, dysfunctional attitudes, physical contact, parenting rules, self care.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. diagnosed with BPD (assessed via SCID-PD)
2. running or completed therapy for BPD symptoms
3. child between 6 months and 6 years
4. living with child or regular (weekly) contact


1. diagnosed with acute affective or anxiety disorder (assessed via SCID-CV)
2. child between 6 months and 6 years
3. living with child or regular (weekly) contact


1. child between 6 months and 6 years
2. living with child or regular (weekly) contact

Exclusion Criteria

1. Acute child endangerment
2. maternal acute suicidality
3. maternal psychotic symptoms (assessed via SCID-CV)
4. maternal acute alcohol or drug dependency (assessed via SCID-CV)
5. maternal diagnosed intellectual disability.


1. Acute child endangerment
2. maternal acute suicidality
3. maternal psychotic symptoms (assessed via SCID-CV)
4. maternal acute alcohol or drug dependency (assessed via SCID-CV)
5. maternal diagnosed intellectual disability
6. lifetime diagnosis of BPD (assessed via SCID-PD)


1. Acute child endangerment
2. maternal acute suicidality
3. maternal psychotic symptoms (assessed via SCID-CV)
4. maternal acute alcohol or drug dependency (assessed via SCID-CV)
5. maternal diagnosed intellectual disability.
6. lifetime diagnosis of BPD (assessed via SCID-PD)
7. any acute mental disorder (assessed via SCID-CV)
8. current psychotherapy
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ruhr University of Bochum

OTHER

Sponsor Role collaborator

University of Bremen

OTHER

Sponsor Role collaborator

Freie Universität Berlin

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Babette Renneberg

Professor of Clinical Psychology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Babette Renneberg, Prof.

Role: PRINCIPAL_INVESTIGATOR

Freie Universität Berlin

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Freie Universität Berlin

Berlin, , Germany

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Germany

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Charlotte Rosenbach, Dr.

Role: CONTACT

00493083851258

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Anne Trösken

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

Buck-Hostkotte, S., Renneberg, B. & Rosenbach, C. (2015). Mütter mit Borderline-Persönlichkeitsstörung. Das Trainingsmanual "Borderline und Mutter sein". Weinheim: Beltz.

Reference Type BACKGROUND

Rosenbach C, Heinrichs N, Kumsta R, Schneider S, Renneberg B. Study protocol for a multi-center RCT testing a group-based parenting intervention tailored to mothers with borderline personality disorder against a waiting control group (ProChild*-SP1). Trials. 2022 Jul 23;23(1):589. doi: 10.1186/s13063-022-06531-2.

Reference Type DERIVED
PMID: 35870944 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RenRos02

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.