Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04169048
Recruitment Status : Recruiting
First Posted : November 19, 2019
Last Update Posted : February 5, 2020
Sponsor:
Collaborators:
Ruhr University of Bochum
University of Bremen
Information provided by (Responsible Party):
Babette Renneberg, Freie Universität Berlin

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.


Condition or disease Intervention/treatment Phase
Borderline Personality Disorder Mothers Behavioral: Group training for mothers with Borderline Personality Disorder Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized controlled trial with intervention group and waiting group (treatment as usual)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Preventing Maltreatment and Promoting Mental Health in Children of Mothers With Borderline Personality Disorder - ProChild
Actual Study Start Date : February 4, 2020
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. Change in dysfunctional discipline practices [ Time Frame: day 0 (before treatment), week 12 (after treatment), month 9 (6 months after second assessment) ]
    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.

  2. Change in positive and dysfunctional parenting strategies [ Time Frame: day 0 (before treatment), week 12 (after treatment), month 9 (6 months after second assessment) ]
    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

  3. Change in child rearing competence [ Time Frame: day 0 (before treatment), week 12 (after treatment), month 9 (6 months after second assessment) ]
    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.

  4. Change in parental stress [ Time Frame: day 0 (before treatment), week 12 (after treatment), month 9 (6 months after second assessment) ]
    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.

  5. Change in physical and psychological aggression towards child [ Time Frame: day 0 (before treatment), week 12 (after treatment), month 9 (6 months after second assessment) ]
    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

  6. Change in physical abuse potential [ Time Frame: day 0 (before treatment), week 12 (after treatment), month 9 (6 months after second assessment) ]
    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.

  7. Change in child 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. ]
    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 :
  1. Change in emotion regulation [ Time Frame: day 0 (before treatment), week 12 (after treatment), month 9 (6 months after second assessment) ]
    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.

  2. Change in mental distress [ Time Frame: day 0 (before treatment), week 12 (after treatment), month 9 (6 months after second assessment) ]
    Brief Symptom Inventory (BSI, Derogatis, 1975; German: Franke, 2000). The BSI measures mental distress. Results are displayed via t-values.

  3. Change in borderline specific thoughts and feelings [ Time Frame: day 0 (before treatment), week 12 (after treatment), month 9 (6 months after second assessment) ]
    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.


Other Outcome Measures:
  1. Negative intervention outcomes [ Time Frame: week 12 (after treatment) (intervention group only) ]
    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.

  2. client satisfaction [ Time Frame: week 12 (after treatment) (intervention group only) ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04169048


Contacts
Layout table for location contacts
Contact: Charlotte Rosenbach, Dr. 00493083851258 c.rosenbach@fu-berlin.de

Locations
Layout table for location information
Germany
Freie Universität Berlin Recruiting
Berlin, Germany
Contact: Anne Trösken         
Sponsors and Collaborators
Freie Universität Berlin
Ruhr University of Bochum
University of Bremen
Investigators
Layout table for investigator information
Principal Investigator: Babette Renneberg, Prof. Freie Universität Berlin

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

Layout table for additonal information
Responsible Party: Babette Renneberg, Professor of Clinical Psychology, Freie Universität Berlin
ClinicalTrials.gov Identifier: NCT04169048    
Other Study ID Numbers: RenRos02
First Posted: November 19, 2019    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Personality Disorders
Borderline Personality Disorder
Mental Disorders