NCT04169048

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 24, 2019

Completed
26 days until next milestone

First Posted

Study publicly available on registry

November 19, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

February 4, 2020

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

February 5, 2020

Status Verified

February 1, 2020

Enrollment Period

2.3 years

First QC Date

October 24, 2019

Last Update Submit

February 4, 2020

Conditions

Borderline Personality DisorderMothers

Outcome Measures

Primary Outcomes (7)

  • Change in dysfunctional discipline practices

    Parenting Scale (Arnold, O'Leary, Wolff \& Acker, 1993; german version: Erziehungsfragebogen-Kurzform, EFB-K; Miller, 2001). Questionniare measuring dysfunctional discipline practices in parents. Mean values range between 1-7 with higher values indicating more negative parenting strategies.

    day 0 (before treatment), week 12 (after treatment), month 9 (6 months after second assessment)

  • Change in positive and dysfunctional parenting strategies

    Alabama Parenting Questionnaire (Frick, 1991; German DEAPQ-EL-GS; Reichle \& Franiek, 2007). The questionnaire assesses several parenting strategies with 7 subscales (positive parenting, responsible parenting, parental Involvement, poor monitoring/supervision, inconsistent discipline, corporal punishment, powerful implementation). Range 6-30, with higher values indicating more of the respective parenting strategy

    day 0 (before treatment), week 12 (after treatment), month 9 (6 months after second assessment)

  • Change in child rearing competence

    Parenting Sense of Competence Scale (PSOC, Gibeau- Wallston \& Wandersman, 1978; German FKE; Miller, 2001). The PSOC measures how parents perceive their child rearing competence. Range 0-96 with higher values indicating higher sense of competence.

    day 0 (before treatment), week 12 (after treatment), month 9 (6 months after second assessment)

  • Change in parental stress

    Parental Stress Index (PSI, Abidin, 1995; German EBI; Tröster, 2010). The PSI is a dimensional rating of parental stress. Range 48 - 240 with higher values indicating higher stress.

    day 0 (before treatment), week 12 (after treatment), month 9 (6 months after second assessment)

  • Change in physical and psychological aggression towards child

    Conflict Tactic Scale - Parent Child (CTS-PC; Strauss, 1998). The CTSPC measures the extent to which a parent has carried out specific acts of physical and psychological aggression. Range 0-300 with higher values indicating higher annual frequency

    day 0 (before treatment), week 12 (after treatment), month 9 (6 months after second assessment)

  • Change in physical abuse potential

    Child Abuse Potential Inventory (CAPI, Milner, 1986, German EBSK; Deegener et al., 2009). The CAPI measures physical abuse potential with reference to the individual burden and three validity scales: a lie scale, a random response scale, and an inconsistency scale. t-values are calculated considering all scales.

    day 0 (before treatment), week 12 (after treatment), month 9 (6 months after second assessment)

  • Change in child neglect

    Child Neglect Index (CNI; Trocmé, 1996). The CNI measures child neglect, rated by the diagnostician. Range 0-80 with higher values indicating higher neglect.

    day 0 (before treatment), week 12 (after treatment), month 9 (6 months after second assessment) and for the intervention group after each session.

Secondary Outcomes (3)

  • Change in emotion regulation

    day 0 (before treatment), week 12 (after treatment), month 9 (6 months after second assessment)

  • Change in mental distress

    day 0 (before treatment), week 12 (after treatment), month 9 (6 months after second assessment)

  • Change in borderline specific thoughts and feelings

    day 0 (before treatment), week 12 (after treatment), month 9 (6 months after second assessment)

Other Outcomes (2)

  • Negative intervention outcomes

    week 12 (after treatment) (intervention group only)

  • client satisfaction

    week 12 (after treatment) (intervention group only)

Study Arms (4)

Intervention group (BPD)

EXPERIMENTAL

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).

Behavioral: Group training for mothers with Borderline Personality Disorder

waiting control group (BPD)

NO INTERVENTION

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).

clinical control group (AD/MDD)

NO INTERVENTION

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

healthy control group

NO INTERVENTION

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

Interventions

Group training for mothers with Borderline Personality DisorderBEHAVIORAL

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 group (BPD)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Acute child endangerment
  • maternal acute suicidality
  • maternal psychotic symptoms (assessed via SCID-CV)
  • maternal acute alcohol or drug dependency (assessed via SCID-CV)
  • maternal diagnosed intellectual disability.
  • diagnosed with acute affective or anxiety disorder (assessed via SCID-CV)
  • child between 6 months and 6 years
  • living with child or regular (weekly) contact
  • Acute child endangerment
  • maternal acute suicidality
  • maternal psychotic symptoms (assessed via SCID-CV)
  • maternal acute alcohol or drug dependency (assessed via SCID-CV)
  • maternal diagnosed intellectual disability
  • lifetime diagnosis of BPD (assessed via SCID-PD)
  • child between 6 months and 6 years
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Freie Universität Berlin

Berlin, Germany

RECRUITING

Related Publications (2)

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

    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.

    PMID: 35870944DERIVED

MeSH Terms

Conditions

Borderline Personality Disorder

Condition Hierarchy (Ancestors)

Personality DisordersMental Disorders

Study Officials

  • Babette Renneberg, Prof.

    Freie Universität Berlin

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Charlotte Rosenbach, Dr.

CONTACT

00493083851258c.rosenbach@fu-berlin.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomized controlled trial with intervention group and waiting group (treatment as usual)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Clinical Psychology

Study Record Dates

First Submitted

October 24, 2019

First Posted

November 19, 2019

Study Start

February 4, 2020

Primary Completion

June 1, 2022

Study Completion

March 1, 2023

Last Updated

February 5, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will share

Locations

DE(1)