Borderline Personality DisorderProChildNCT04169048
Parenting Skills for Mothers With Borderline Personality Disorder (BPD)
A study testing Group training for mothers with Borderline Personality Disorder in people with Borderline Personality Disorder and Mothers, run by Freie Universität Berlin at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Borderline Personality Disorder, Mothers
- What is being tested?
- Group training for mothers with Borderline Personality Disorder
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteGermany
- Study dates
- 4 Feb 2020to Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
- child between 6 months and 6 years
- living with child or regular (weekly) contact
Who cannot join
- 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:
Show all 24Show fewer
- 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)
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Freie Universität Berlin
Berlin
Anne Trösken
About this study
Official title: Preventing Maltreatment and Promoting Mental Health in Children of Mothers With Borderline Personality Disorder - ProChild
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).
Read more
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.
- Conditions
- Borderline Personality Disorder, Mothers
- Being tested
- Group training for mothers with Borderline Personality Disorder
- Medical subject headings
- Borderline Personality Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group training for mothers with Borderline Personality DisorderBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group (BPD) | Experimental | 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). Receives: Behavioral: Group training for mothers with Borderline Personality Disorder |
| waiting control group (BPD) | No intervention | 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). |
| clinical control group (AD/MDD) | No intervention | Mothers with anxiety and/or depression (N=60) receive no intervention. Assessment point only T0. |
| healthy control group | No intervention | Mothers with no actual mental disorder (N=60) receive no intervention.# Assessment points T0, T1, T2. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: day 0 (before treatment), week 12 (after treatment), month 9 (6 months after second assessment) and for the intervention group after each session.
Secondary outcomes (3)
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.
Measured: day 0 (before treatment), week 12 (after treatment), month 9 (6 months after second assessment)
Change in mental distress
Brief Symptom Inventory (BSI, Derogatis, 1975; German: Franke, 2000). The BSI measures mental distress. Results are displayed via t-values.
Measured: day 0 (before treatment), week 12 (after treatment), month 9 (6 months after second assessment)
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.
Measured: day 0 (before treatment), week 12 (after treatment), month 9 (6 months after second assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2019
- Study start4 Feb 2020
- Primary completionJun 2022 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Borderline Personality DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled trial with intervention group and waiting group (treatment as usual)
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Freie Universität Berlin
- Sponsor type
- University, hospital or other
- Collaborators
- Ruhr University of Bochum, University of Bremen
- Responsible party
- Principal investigator, Babette Renneberg, Freie Universität Berlin
- Investigators
- Babette Renneberg, Prof., Principal investigator, Freie Universität Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04169048
- Sponsor's protocol ID
- RenRos02
- Acronym
- ProChild
- Status last verified
- Feb 2020
- First submitted
- 24 Oct 2019
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 35870944
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Maltreatment and Promoting Mental Health in Children of Mothers With Borderline Personality Disorder - ProChild
- ClinicalTrials.gov ID
- NCT04169048
- Acronym / sponsor ID
- ProChild / RenRos02
- Conditions
- Borderline Personality Disorder, Mothers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Freie Universität BerlinUniversity, hospital or other
- Collaborators
- Ruhr University of Bochum, University of Bremen
- Study start
- 4 Feb 2020 (actual)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 19 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- randomized controlled trial with intervention group and waiting group (treatment as usual)
| Arm | Type | Receives |
|---|---|---|
| Intervention group (BPD) | Experimental | Behavioral: Group training for mothers with Borderline Personality DisorderParticipants (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). |
| waiting control group (BPD) | No intervention | –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). |
| clinical control group (AD/MDD) | No intervention | –Mothers with anxiety and/or depression (N=60) receive no intervention. Assessment point only T0. |
| healthy control group | No intervention | –Mothers with no actual mental disorder (N=60) receive no intervention.# Assessment points T0, T1, T2. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
- child between 6 months and 6 years
Key exclusion criteria (24 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group training for mothers with Borderline Personality DisorderThe 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. | Behavioural | Intervention group (BPD) |
Primary outcome
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 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 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 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.
3 secondary outcomes
Change in emotion regulation
Time frame: day 0 (before treatment), week 12 (after treatment), month 9 (6 months after second assessment)
Change in mental distress
Time frame: day 0 (before treatment), week 12 (after treatment), month 9 (6 months after second assessment)
Change in borderline specific thoughts and feelings
Time frame: day 0 (before treatment), week 12 (after treatment), month 9 (6 months after second assessment)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- BackgroundBuck-Hostkotte, S., Renneberg, B. & Rosenbach, C. (2015). Mütter mit Borderline-Persönlichkeitsstörung. Das Trainingsmanual "Borderline und Mutter sein". Weinheim: Beltz.
- Derived from this study: PubMed 35870944Rosenbach 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Babette Renneberg, Prof. principal investigator
Freie Universität Berlin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group training for mothers with Borderline Personality Disorder in people with Borderline Personality Disorder and Mothers, run by Freie Universität Berlin at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Charlotte Rosenbach, Dr. (00493083851258, c.rosenbach@fu-berlin.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in dysfunctional discipline practices (time frame: day 0 (before treatment), week 12 (after treatment), month 9 (6 months after second assessment)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04169048, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020.