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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	19 February 2015
Main ID:	NCT02203708
Date of registration:	22/01/2013
Prospective Registration:	No
Primary sponsor:	University Hospital, Toulouse
Public title:	Supportive Program for Mother With BPD PAM-B
Scientific title:	Effect on Relationship of a Brief Preventive Program: Pragmatic Pilot Randomized Controlled Trial." - Supportive Program for Mother With BPD
Date of first enrolment:	July 2012
Target sample size:	10
Recruitment status:	Completed
URL:	http://clinicaltrials.gov/show/NCT02203708
Study type:	Interventional
Study design:	Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
Phase:	N/A

Countries of recruitment
France

Contacts

Name:	MULQUIN
Address:
Telephone:
Email:
Affiliation:	UTAMS PMI Rangueil

Name:	BLEY-RIBET
Address:
Telephone:
Email:
Affiliation:	UTAMS PMI Bonnefoy

Name:	CHEYNIER
Address:
Telephone:
Email:
Affiliation:	UTAMS PMI Empalot

Name:	LATOUR
Address:
Telephone:
Email:
Affiliation:	UTAMS PMI Reynerie

Name:	BERTIN
Address:
Telephone:
Email:
Affiliation:	UTAMS PMI Montauban

Name:	KOUBAA
Address:
Telephone:
Email:
Affiliation:	UTAMS PMI Cazères

Key inclusion & exclusion criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Borderline Personality Disorder

Parent-child Problem

Intervention(s)

Other: Supportive Program for Mother with BPD (SuPMother-B).

Primary Outcome(s)

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]

Secondary Outcome(s)

Data on care pathways [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)]

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)]

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)]

Brunet-Lezine Scale [Time Frame: Visit 2 (inclusion), 3 (6 months) and 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)]

Secondary ID(s)

11 199 08

Interregional PHRC 2011

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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