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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

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:

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

Sites / Locations

Freie Universität BerlinRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

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

NCT ID

NCT04169048

First Posted

October 24, 2019

Last Updated

February 4, 2020

Sponsor

Freie Universität Berlin

Collaborators

Ruhr University of Bochum, University of Bremen

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

Studies a U.S. FDA-regulated Device Product

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

Arm Title

waiting control group (BPD)

Arm Type

No Intervention

Arm Description

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

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

Time Frame

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

Title

Change in child rearing competence

Description

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

Time Frame

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

Title

Change in physical abuse potential

Description

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

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

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

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

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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