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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04169048
Other study ID # RenRos02
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 4, 2020
Est. completion date March 2023

Study information

Verified date February 2020
Source Freie Universität Berlin
Contact Charlotte Rosenbach, Dr.
Phone 00493083851258
Email c.rosenbach@fu-berlin.de
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 240
Est. completion date March 2023
Est. primary completion date June 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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 Design


Intervention

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.

Locations

Country Name City State
Germany Freie Universität Berlin Berlin

Sponsors (3)

Lead Sponsor Collaborator
Freie Universität Berlin Ruhr University of Bochum, University of Bremen

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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

Outcome

Type Measure Description Time frame Safety issue
Other 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)
Other 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)
Primary 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)
Primary 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)
Primary 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)
Primary 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)
Primary 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)
Primary 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)
Primary 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 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)
Secondary 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)
Secondary 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)
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