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Clinical Trials/NCT04169048
NCT04169048
Unknown
Not Applicable

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

Freie Universität Berlin1 site in 1 country240 target enrollmentFebruary 4, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Borderline Personality Disorder
Sponsor
Freie Universität Berlin
Enrollment
240
Locations
1
Primary Endpoint
Change in dysfunctional discipline practices
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 4, 2020
End Date
March 2023
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Babette Renneberg

Professor of Clinical Psychology

Freie Universität Berlin

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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.

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

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

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.

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.

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.

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 Outcomes

  • Change in emotion regulation(day 0 (before treatment), week 12 (after treatment), month 9 (6 months after second assessment))
  • Change in borderline specific thoughts and feelings(day 0 (before treatment), week 12 (after treatment), month 9 (6 months after second assessment))
  • Change in mental distress(day 0 (before treatment), week 12 (after treatment), month 9 (6 months after second assessment))

Study Sites (1)

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