Parenting Skills for Mothers With Borderline Personality Disorder (BPD) (ProChild)

Preventing Maltreatment and Promoting Mental Health in Children of Mothers With Borderline Personality Disorder - ProChild

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.

Study Overview

• Status: Recruiting
• Conditions: Borderline Personality Disorder; Mothers
• Intervention / Treatment: Behavioral: Group training for mothers with Borderline Personality Disorder

• Study Type: Interventional
• Enrollment (Anticipated): 240
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Charlotte Rosenbach, Dr.; Phone Number: 00493083851258; Email: c.rosenbach@fu-berlin.de

Study Locations

• Germany
  • Berlin, Germany
    • Recruiting
    • Freie Universität Berlin
    • Contact: Anne Trösken

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Behavioral: 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.
No Intervention: 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).
No Intervention: clinical control group (AD/MDD); Mothers with anxiety and/or depression (N=60) receive no intervention. Assessment point only T0.
No Intervention: healthy control group; Mothers with no actual mental disorder (N=60) receive no intervention.# Assessment points T0, T1, T2.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in emotion regulation	Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2004). Difficulties in emotion regulation are measured with a) awareness and understanding of emotions; (b) acceptance of emotions; (c) the ability to engage in goal-directed behavior, and refrain from impulsive behavior, when experiencing negative emotions; and (d) access to emotion regulation strategies perceived as effective. Range 36 - 180 with higher values indicating more problems in emotion regulation.	day 0 (before treatment), week 12 (after treatment), month 9 (6 months after second assessment)
Change in mental distress	Brief Symptom Inventory (BSI, Derogatis, 1975; German: Franke, 2000). The BSI measures mental distress. Results are displayed via t-values.	day 0 (before treatment), week 12 (after treatment), month 9 (6 months after second assessment)
Change in borderline specific thoughts and feelings	Questionnaire of Thoughts and Feelings (QTF, Renneberg et al., 2010). The QTF measures borderline specific thoughts and feelings. Range 1-5 with higher values indicating more BPD-specific thoughts and feelings.	day 0 (before treatment), week 12 (after treatment), month 9 (6 months after second assessment)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Negative intervention outcomes	Questionniare assessing negative intervention outcomes (INEP, Ladwig, Rief, & Nestoriouc, 2014).The INEP measures negative effects of psychotherapy in different areas of life (intrapersonal change, relationships, friendships, family, malpractice, and stigmatization). Range from -3 to +3. Higher values indicating better therapeutic course.	week 12 (after treatment) (intervention group only)
client satisfaction	Client Satisfaction Questionnaire (CSQ-8, Attkisson & Zwick, 1982; German ZUF-8; Schmidt, Lamprecht & Wittmann, 1989). CSQ-8 measures client satisfaction with intervention. Range 8-32 with higher values indicating greater satisfaction.	week 12 (after treatment) (intervention group only)

Collaborators and Investigators

• Sponsor: Freie Universität Berlin
• Collaborators: Ruhr University of Bochum; University of Bremen
• Investigators: Principal Investigator: Babette Renneberg, Prof., Freie Universität Berlin

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (Actual): February 4, 2020
• Primary Completion (Anticipated): June 1, 2022
• Study Completion (Anticipated): March 1, 2023

Study Registration Dates

• First Submitted: October 24, 2019
• First Submitted That Met QC Criteria: November 18, 2019
• First Posted (Actual): November 19, 2019

Study Record Updates

• Last Update Posted (Actual): February 5, 2020
• Last Update Submitted That Met QC Criteria: February 4, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Personality Disorders; Borderline Personality Disorder
• Other Study ID Numbers: RenRos02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No