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

Primary Purpose

Borderline Personality Disorder, Mothers

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Group training for mothers with Borderline Personality Disorder
Sponsored by
Freie Universität Berlin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Borderline Personality Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Freie Universität BerlinRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

No Intervention

No Intervention

No Intervention

Arm Label

Intervention group (BPD)

waiting control group (BPD)

clinical control group (AD/MDD)

healthy control group

Arm Description

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).

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).

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

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

Outcomes

Primary Outcome Measures

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.
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
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.
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.
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
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.
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.

Secondary Outcome Measures

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.
Change in mental distress
Brief Symptom Inventory (BSI, Derogatis, 1975; German: Franke, 2000). The BSI measures mental distress. Results are displayed via t-values.
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.

Full Information

First Posted
October 24, 2019
Last Updated
February 4, 2020
Sponsor
Freie Universität Berlin
Collaborators
Ruhr University of Bochum, University of Bremen
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1. Study Identification

Unique Protocol Identification Number
NCT04169048
Brief Title
Parenting Skills for Mothers With Borderline Personality Disorder (BPD)
Acronym
ProChild
Official Title
Preventing Maltreatment and Promoting Mental Health in Children of Mothers With Borderline Personality Disorder - ProChild
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 4, 2020 (Actual)
Primary Completion Date
June 2022 (Anticipated)
Study Completion Date
March 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Freie Universität Berlin
Collaborators
Ruhr University of Bochum, University of Bremen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Borderline Personality Disorder, Mothers

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized controlled trial with intervention group and waiting group (treatment as usual)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group (BPD)
Arm Type
Experimental
Arm Description
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).
Arm Title
waiting control group (BPD)
Arm Type
No Intervention
Arm Description
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).
Arm Title
clinical control group (AD/MDD)
Arm Type
No Intervention
Arm Description
Mothers with anxiety and/or depression (N=60) receive no intervention. Assessment point only T0.
Arm Title
healthy control group
Arm Type
No Intervention
Arm Description
Mothers with no actual mental disorder (N=60) receive no intervention.# Assessment points T0, T1, T2.
Intervention Type
Behavioral
Intervention Name(s)
Group training for mothers with Borderline Personality Disorder
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in dysfunctional discipline practices
Description
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.
Time Frame
day 0 (before treatment), week 12 (after treatment), month 9 (6 months after second assessment)
Title
Change in positive and dysfunctional parenting strategies
Description
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
Time Frame
day 0 (before treatment), week 12 (after treatment), month 9 (6 months after second assessment)
Title
Change in child rearing competence
Description
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.
Time Frame
day 0 (before treatment), week 12 (after treatment), month 9 (6 months after second assessment)
Title
Change in parental stress
Description
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.
Time Frame
day 0 (before treatment), week 12 (after treatment), month 9 (6 months after second assessment)
Title
Change in physical and psychological aggression towards child
Description
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
Time Frame
day 0 (before treatment), week 12 (after treatment), month 9 (6 months after second assessment)
Title
Change in physical abuse potential
Description
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.
Time Frame
day 0 (before treatment), week 12 (after treatment), month 9 (6 months after second assessment)
Title
Change in child neglect
Description
Child Neglect Index (CNI; Trocmé, 1996). The CNI measures child neglect, rated by the diagnostician. Range 0-80 with higher values indicating higher neglect.
Time Frame
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 Measure Information:
Title
Change in emotion regulation
Description
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.
Time Frame
day 0 (before treatment), week 12 (after treatment), month 9 (6 months after second assessment)
Title
Change in mental distress
Description
Brief Symptom Inventory (BSI, Derogatis, 1975; German: Franke, 2000). The BSI measures mental distress. Results are displayed via t-values.
Time Frame
day 0 (before treatment), week 12 (after treatment), month 9 (6 months after second assessment)
Title
Change in borderline specific thoughts and feelings
Description
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.
Time Frame
day 0 (before treatment), week 12 (after treatment), month 9 (6 months after second assessment)
Other Pre-specified Outcome Measures:
Title
Negative intervention outcomes
Description
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.
Time Frame
week 12 (after treatment) (intervention group only)
Title
client satisfaction
Description
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.
Time Frame
week 12 (after treatment) (intervention group only)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria for mothers with BPD: 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 Exclusion criteria for the mothers with BPD 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. Inclusion criteria for mothers with depression and/or anxiety disorders: 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 Exclusion criteria for mothers with depression and/or anxiety disorders: 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) Inclusion criteria for healthy control group: child between 6 months and 6 years living with child or regular (weekly) contact Exclusion criteria for the healthy control group: 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) any acute mental disorder (assessed via SCID-CV) current psychotherapy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Charlotte Rosenbach, Dr.
Phone
00493083851258
Email
c.rosenbach@fu-berlin.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Babette Renneberg, Prof.
Organizational Affiliation
Freie Universität Berlin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Freie Universität Berlin
City
Berlin
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne Trösken

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
Citation
Buck-Hostkotte, S., Renneberg, B. & Rosenbach, C. (2015). Mütter mit Borderline-Persönlichkeitsstörung. Das Trainingsmanual "Borderline und Mutter sein". Weinheim: Beltz.
Results Reference
background
PubMed Identifier
35870944
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.
Results Reference
derived

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Parenting Skills for Mothers With Borderline Personality Disorder (BPD)

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