Clinical trial NCT04169048: Parenting Skills for Mothers With Borderline Personality Disorder (BPD)
Official title: Preventing Maltreatment and Promoting Mental Health in Children of Mothers With Borderline Personality Disorder - ProChild
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Borderline Personality Disorder
Mothers
Lead sponsor: Freie Universität Berlin
Sponsor class: OTHER
Collaborators: name: Ruhr University of Bochum
name: University of Bremen
First posted: 2019-11-19
Enrollment: 240
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled trial with intervention group and waiting group (treatment as usual)
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion criteria for mothers with BPD:

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

Exclusion criteria for the mothers with BPD

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.

Inclusion criteria for mothers with depression and/or anxiety disorders:

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

Exclusion criteria for mothers with depression and/or anxiety disorders:

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)

Inclusion criteria for healthy control group:

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

Exclusion criteria for the healthy control group:

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

Primary outcomes:
measure: Change in dysfunctional discipline practices
timeFrame: day 0 (before treatment), week 12 (after treatment), month 9 (6 months after second assessment)
measure: Change in positive and dysfunctional parenting strategies
timeFrame: day 0 (before treatment), week 12 (after treatment), month 9 (6 months after second assessment)
measure: Change in child rearing competence
timeFrame: day 0 (before treatment), week 12 (after treatment), month 9 (6 months after second assessment)
measure: Change in parental stress
timeFrame: day 0 (before treatment), week 12 (after treatment), month 9 (6 months after second assessment)
measure: Change in physical and psychological aggression towards child
timeFrame: day 0 (before treatment), week 12 (after treatment), month 9 (6 months after second assessment)
measure: Change in physical abuse potential
timeFrame: day 0 (before treatment), week 12 (after treatment), month 9 (6 months after second assessment)
measure: Change in child neglect
timeFrame: 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:
measure: Change in emotion regulation
timeFrame: day 0 (before treatment), week 12 (after treatment), month 9 (6 months after second assessment)
measure: Change in mental distress
timeFrame: day 0 (before treatment), week 12 (after treatment), month 9 (6 months after second assessment)
measure: Change in borderline specific thoughts and feelings
timeFrame: day 0 (before treatment), week 12 (after treatment), month 9 (6 months after second assessment)
Other outcomes:
measure: Negative intervention outcomes
timeFrame: week 12 (after treatment) (intervention group only)
measure: client satisfaction
timeFrame: week 12 (after treatment) (intervention group only)
Locations:
city: Berlin
country: Germany
facility: Freie Universität Berlin
Study officials:
affiliation: Freie Universität Berlin
name: Babette Renneberg, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Buck-Hostkotte, S., Renneberg, B. & Rosenbach, C. (2015). Mütter mit Borderline-Persönlichkeitsstörung. Das Trainingsmanual "Borderline und Mutter sein". Weinheim: Beltz.
citation: 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.