Parent-child ProblemPAM-BNCT02203708
Supportive Program for Mother With BPD
A study testing Supportive Program for Mother with BPD (SuPMother-B). in people with Parent-child Problem and Borderline Personality Disorder, run by University Hospital, Toulouse at 1 site in France.
Trial summary
Borderline Personality Disorder (BPD) is characterized by a pervasive pattern of instability of interpersonal relationships, self-image and emotions as well as marked impulsivity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parent-child Problem, Borderline Personality Disorder
- What is being tested?
- Supportive Program for Mother with BPD (SuPMother-B).
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2012to Jul 2014
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mother:
- Women with children and at least one child aged 2 months to 2 years, Borderline Personality Disorder with SIDP (Structured Interview for DSM Personality Disorders)
- age above 18 years
- written consent
- Child:
- ages between 2 months and 2 years,
- parental consent for research participation.
Who cannot join
- Mother:
- chronic psychotic disorder, major depressive disorder, current mania or hypomania,
- legal protection,
- if no child can be included, the mother cannot be included.
- Child :
- •major psychomotor development disorder or psychiatric disorder according to the investigator.
Trial locations and contacts
1 site in 1 country.
France1 site
Service de psychiatrie de l'enfant et de l'adolescent - Hôpital La Grave - centre Hospitalier de Toulouse
Toulouse, 31059
About this study
Official title: Effect on Relationship of a Brief Preventive Program: Pragmatic Pilot Randomized Controlled Trial." - Supportive Program for Mother With BPD
Borderline Personality Disorder (BPD) is characterized by a pervasive pattern of instability of interpersonal relationships, self-image and emotions as well as marked impulsivity. When patients have children, they are at high risk of severe emotional and relational disturbances (withdrawal, low self-esteem, depression, suicidal thoughts). In addition, studies support the effectiveness of parental guidance group to reduce emotional and behavioral difficulties of children. To our knowledge there are no programs directed to mothers with BPD who received a controlled evaluation.
From experience with parental guidance, data from the observation of children of patients with BPD and psychosocial programs directed to patients BPD, we have built for preventive intervention. The Supportive Program for Mothers with BPD (SuPMother-B) consists of 10 group sessions providing information (education, childcare, care specific to BPD) and promotes mother-child interactions (observation, games).
Read more
Purpose: Compare the effect of a program (SuPMother-B) group, of 10 sessions, offered to mothers with a BPD in addition to a minimal intervention (diagnostic announcement and provision of health care resources) on behavior withdrawal of children at 6 months compared to a group of mothers receiving only minimal intervention.
Primary outcome: Difference at 6 months between the experimental and control groups on scores on the assessment scale withdrawal (Alarm Distress Baby (ADBB)).
- Being tested
- Supportive Program for Mother with BPD (SuPMother-B).
- Keywords
- BPD (Borderline Personality Disorder), Mother/child
- 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.
Supportive Program for Mother with BPD (SuPMother-B).Other
The development of the program is based on several principles: group process, groupware, mentalization, parental values, behavioral strategies and information on the child's needs, knowledge of the BPD and the strategies of get better. The program will last 10 sessions of group of about 2h.
Minimal intervention. All study participants receive an individual interview about 45 minutes with a psychiatrist for three objectives: information on the diagnosis of BPD, information on resources for health care and educational aids.
| Study group | Role | What they receive |
|---|---|---|
| BPD prevention | Active comparator | Supportive Program for Mother with BPD (SuPMother-B) : BPD mothers participate to prevention program in groups or/and house calls. Receives: Other: Supportive Program for Mother with BPD (SuPMother-B). |
| Usual care of BPD mothers | No intervention | BPD mothers don't participate to Supportive Program (SuPMother-B). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between the experimental and control groups on scores on the assessment scale withdrawal (Alarm Distress Baby (ADBB)).
Measured: Visit 3 at 6 months
Secondary outcomes (8)
Brunet-Lezine Scale
This scale permits to assess the psychomotor development of the child.
Measured: Visit 2 (inclusion), 3 (6 months) and 4 (1 year)
Borderline Personality Disorder Severity Index (BPDSI)
Borderline Personality Disorder Severity Index (BPDSI) is a semi-structured interview assessing the frequency and severity of manifestations of borderline personality disorders of the mother during an agreed period (3 months to 1 year).
Measured: Visit 2 (inclusion), 3 (6 months) and 4 (1 year)
Global Assessment Scale
This scale corresponds to the 5th axis of the Diagnostic and Statistical Manual of Mental Disorders (DSM) and permits to assess the overall functioning of the mother.
Measured: Visit 2 (inclusion), Visit 3 (6 months), Visit 4 (1 Year)
Difference between the experimental and control groups on scores on the assessment scale withdrawal (Alarm Distress Baby (ADBB)).
Measured: Visit 2 (inclusion) and visit 4 (1 Year)
M.I.N.I. 5.0.0 French version
Structured interview to assess 17 disorders such as actual or passed depression, mania, abuse...
Measured: Visit 2 (inclusion), Visit 3 (6 months), Visit 4 (1 year)
Parenting Sense of Competence Scale (P.S.O.C)
This scale assess the perceived competence of the parent's role as educator.
Measured: Visit 2 (inclusion), Visit 3 (6 months), Visit 4 (1 year)
social and demographic data
marital status, profession, socio-economic level, number of children
Measured: Visit 2 (inclusion), Visit 3 (6 months), Visit 4 (1 year)
Data on care pathways
Questionnaire established by the research team to evaluate the use of care services by the mothers and children.
Measured: Visit 2 (inclusion), Visit 3 (6 months), Visit 4 (1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2014 (estimated)
- Study startJul 2012
- Primary completionMay 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parent-child ProblemStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- CHEYNIER, Principal investigator, UTAMS PMI EmpalotLATOUR, Principal investigator, UTAMS PMI ReynerieBLEY-RIBET, Principal investigator, UTAMS PMI BonnefoyMULQUIN, Principal investigator, UTAMS PMI RangueilKOUBAA, Principal investigator, UTAMS PMI CazèresBERTIN, Principal investigator, UTAMS PMI Montauban
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02203708
- Sponsor's protocol ID
- 11 199 08
- Other IDs
- Interregional PHRC 2011
- Acronym
- PAM-B
- Status last verified
- Jul 2014
- First submitted
- 22 Jan 2013
- Last updated
- 30 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect on Relationship of a Brief Preventive Program: Pragmatic Pilot Randomized Controlled Trial." - Supportive Program for Mother With BPD
- ClinicalTrials.gov ID
- NCT02203708
- Acronym / sponsor ID
- PAM-B / 11 199 08
- Keywords
- BPD (Borderline Personality Disorder), Mother/child
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- May 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 30 Jul 2014 (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.
Borderline Personality Disorder (BPD) is characterized by a pervasive pattern of instability of interpersonal relationships, self-image and emotions as well as marked impulsivity. When patients have children, they are at high risk of severe emotional and relational disturbances (withdrawal, low self-esteem, depression, suicidal thoughts). In addition, studies support the effectiveness of parental guidance group to reduce emotional and behavioral difficulties of children. To our knowledge there are no programs directed to mothers with BPD who received a controlled evaluation.
From experience with parental guidance, data from the observation of children of patients with BPD and psychosocial programs directed to patients BPD, we have built for preventive intervention. The Supportive Program for Mothers with BPD (SuPMother-B) consists of 10 group sessions providing information (education, childcare, care specific to BPD) and promotes mother-child interactions (observation, games).
Purpose: Compare the effect of a program (SuPMother-B) group, of 10 sessions, offered to mothers with a BPD in addition to a minimal intervention (diagnostic announcement and provision of health care resources) on behavior withdrawal of children at 6 months compared to a group of mothers receiving only minimal intervention.
Primary outcome: Difference at 6 months between the experimental and control groups on scores on the assessment scale withdrawal (Alarm Distress Baby (ADBB)).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BPD prevention | Active comparator | Other: Supportive Program for Mother with BPD (SuPMother-B).Supportive Program for Mother with BPD (SuPMother-B) : BPD mothers participate to prevention program in groups or/and house calls. |
| Usual care of BPD mothers | No intervention | –BPD mothers don't participate to Supportive Program (SuPMother-B). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Women with children and at least one child aged 2 months to 2 years, Borderline Personality Disorder with SIDP (Structured Interview for DSM Personality Disorders)
- age above 18 years
- written consent
- ages between 2 months and 2 years,
- parental consent for research participation.
Key exclusion criteria (6 listed)
- chronic psychotic disorder, major depressive disorder, current mania or hypomania,
- legal protection,
- if no child can be included, the mother cannot be included.
- •major psychomotor development disorder or psychiatric disorder according to the investigator.
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 |
|---|---|---|
| Supportive Program for Mother with BPD (SuPMother-B).The development of the program is based on several principles: group process, groupware, mentalization, parental values, behavioral strategies and information on the child's needs, knowledge of the BPD and the strategies of get better. The program will last 10 sessions of group of about 2h. Minimal intervention. All study participants receive an individual interview about 45 minutes with a psychiatrist for three objectives: information on the diagnosis of BPD, information on resources for health care and educational aids. | Other | BPD prevention |
Primary outcome
Difference between the experimental and control groups on scores on the assessment scale withdrawal (Alarm Distress Baby (ADBB)).
Time frame: Visit 3 at 6 months
8 secondary outcomes
Brunet-Lezine Scale
Time frame: Visit 2 (inclusion), 3 (6 months) and 4 (1 year)
Borderline Personality Disorder Severity Index (BPDSI)
Time frame: Visit 2 (inclusion), 3 (6 months) and 4 (1 year)
Global Assessment Scale
Time frame: Visit 2 (inclusion), Visit 3 (6 months), Visit 4 (1 Year)
Difference between the experimental and control groups on scores on the assessment scale withdrawal (Alarm Distress Baby (ADBB)).
Time frame: Visit 2 (inclusion) and visit 4 (1 Year)
M.I.N.I. 5.0.0 French version
Time frame: Visit 2 (inclusion), Visit 3 (6 months), Visit 4 (1 year)
Parenting Sense of Competence Scale (P.S.O.C)
Time frame: Visit 2 (inclusion), Visit 3 (6 months), Visit 4 (1 year)
social and demographic data
Time frame: Visit 2 (inclusion), Visit 3 (6 months), Visit 4 (1 year)
Data on care pathways
Time frame: Visit 2 (inclusion), Visit 3 (6 months), Visit 4 (1 year)
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 30 Jul 2014.
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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.
CHEYNIER principal investigator
UTAMS PMI Empalot
LATOUR principal investigator
UTAMS PMI Reynerie
BLEY-RIBET principal investigator
UTAMS PMI Bonnefoy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supportive Program for Mother with BPD (SuPMother-B). in people with Parent-child Problem and Borderline Personality Disorder, run by University Hospital, Toulouse at 1 site in France.
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 7 inclusion and 6 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 30 Jul 2014. 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 France. 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?
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?
Difference between the experimental and control groups on scores on the assessment scale withdrawal (Alarm Distress Baby (ADBB)). (time frame: Visit 3 at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jul 2014.