Borderline Personality DisorderNCT02935218
Parenting Skills for Mothers With Borderline Personality Disorder: A Newly Developed Group Training Program
A study testing Parenting Skills for Mothers with BPD in people with Borderline Personality Disorder, run by Freie Universität Berlin.
Trial summary
N=15 mothers with Borderline Personality Disorder who had young children (aged 0-6 years) participated in a 12-week training program. To estimate the participants' impairment, parental stress and psychological distress were assessed before the training. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Borderline Personality Disorder
- What is being tested?
- Parenting Skills for Mothers with BPD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Oct 2015
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Borderline diagnosis in mothers
- Infants between 6 months and 6 years
- Mothers and their children must be in regular contact with each other
Who cannot join
- Acute child endangerment
- Maternal acute suicidality
About this study
N=15 mothers with Borderline Personality Disorder who had young children (aged 0-6 years) participated in a 12-week training program. To estimate the participants' impairment, parental stress and psychological distress were assessed before the training. After the training, participants and trainers were asked to provide feedback regarding the valuation of and the changes due to the training.
- Conditions
- Borderline Personality Disorder
- Being tested
- Parenting Skills for Mothers with BPD
- 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.
Parenting Skills for Mothers with BPDBehavioural
The cognitive-behavioral Group Training for mothers with BPD consists of 12 weekly sessions promoting parenting skills including primary needs of children, stress and stress management, dealing with conflicts, mindfulness, emotion regulation, routine and flexibility, the role of the body in parenting, basic assumptions about parenting, and self-care.
| Study group | Role | What they receive |
|---|---|---|
| Parenting Skills for Mothers with BPD | Other | single-arm study Receives: Behavioral: Parenting Skills for Mothers with BPD |
What is being measured
The primary outcome is the main question the study is designed to answer.
written feedback
the participants provide written feedback regarding the changes due to the parental skills training
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2016 (estimated)
- Study startJan 2015
- Primary completionApr 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Freie Universität Berlin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Charlotte Rosenbach, Freie Universität Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02935218
- Sponsor's protocol ID
- RenRos01
- Status last verified
- Sep 2016
- First submitted
- 30 Aug 2016
- Last updated
- 17 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: qualitative data not suitable for sharing
Publications
Renneberg B, Rosenbach C. "There is not much help for mothers like me": Parenting Skills for Mothers with Borderline Personality Disorder - a newly developed group training program. Borderline Personal Disord Emot Dysregul. 2016 Dec 1;3:16. doi: 10.1186/s40479-016-0050-4. eCollection 2016.
PubMed 27980787
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parenting Skills for Mothers With Borderline Personality Disorder: A Newly Developed Group Training Program
- ClinicalTrials.gov ID
- NCT02935218
- Acronym / sponsor ID
- RenRos01
- Conditions
- Borderline Personality Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Freie Universität BerlinUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Apr 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 17 Oct 2016 (estimated)
- 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.
N=15 mothers with Borderline Personality Disorder who had young children (aged 0-6 years) participated in a 12-week training program. To estimate the participants' impairment, parental stress and psychological distress were assessed before the training. After the training, participants and trainers were asked to provide feedback regarding the valuation of and the changes due to the training.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parenting Skills for Mothers with BPD | Other | Behavioral: Parenting Skills for Mothers with BPDsingle-arm study |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Borderline diagnosis in mothers
- Infants between 6 months and 6 years
- Mothers and their children must be in regular contact with each other
Key exclusion criteria (2 listed)
- Acute child endangerment
- Maternal acute suicidality
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 |
|---|---|---|
| Parenting Skills for Mothers with BPDThe cognitive-behavioral Group Training for mothers with BPD consists of 12 weekly sessions promoting parenting skills including primary needs of children, stress and stress management, dealing with conflicts, mindfulness, emotion regulation, routine and flexibility, the role of the body in parenting, basic assumptions about parenting, and self-care. | Behavioural | Parenting Skills for Mothers with BPD |
Primary outcome
written feedback
Time frame: 12 weeks
the participants provide written feedback regarding the changes due to the parental skills training
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2016.
- Derived from this study: PubMed 27980787Renneberg B, Rosenbach C. "There is not much help for mothers like me": Parenting Skills for Mothers with Borderline Personality Disorder - a newly developed group training program. Borderline Personal Disord Emot Dysregul. 2016 Dec 1;3:16. doi: 10.1186/s40479-016-0050-4. eCollection 2016.
- Individual participant dataSharing planned: No. qualitative data not suitable for sharing
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Parenting Skills for Mothers with BPD in people with Borderline Personality Disorder, run by Freie Universität Berlin.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 17 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
written feedback (time frame: 12 weeks). 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 NCT02935218, which also lists 1 linked publication.
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 17 Oct 2016.