NCT04169048|UnknownDMC
Parenting Skills for Mothers With Borderline Personality Disorder (BPD)
ProChild
Preventing Maltreatment and Promoting Mental Health in Children of Mothers With Borderline Personality Disorder - ProChild
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ProChild
Preventing Maltreatment and Promoting Mental Health in Children of Mothers With Borderline Personality Disorder - ProChild
Sponsor study identifier
interventional
240
1 country
1
Study Start
February 4, 2020
Actual (reported)Primary Completion
June 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 24, 2019
Actual (reported)November 19, 2019
Actual (reported)February 4, 2020
Actual (reported)June 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
March 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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)
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)
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)
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 emotion regulation
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)
Change in borderline specific thoughts and feelings
day 0 (before treatment), week 12 (after treatment), month 9 (6 months after second assessment)
Negative intervention outcomes
week 12 (after treatment) (intervention group only)
client satisfaction
week 12 (after treatment) (intervention group only)
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Freie Universität Berlin
Berlin, Germany
Buck-Hostkotte, S., Renneberg, B. & Rosenbach, C. (2015). Mütter mit Borderline-Persönlichkeitsstörung. Das Trainingsmanual "Borderline und Mutter sein". Weinheim: Beltz.
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.
Babette Renneberg, Prof.
Freie Universität Berlin
First Submitted
October 24, 2019
First Posted
November 19, 2019
Study Start
February 4, 2020
Actual (reported)Primary Completion
Training of Neural Responding in BPD
day 0 (before treatment), week 12 (after treatment), month 9 (6 months after second assessment)
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)
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)
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.
Mothers with no actual mental disorder (N=60) receive no intervention.# Assessment points T0, T1, T2.
Contact the study team to confirm eligibility.
June 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
February 5, 2020
Record last verified: 2020-02
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Source: ClinicalTrials.gov.
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