Evaluation of the New Orleans Intervention for Infant Mental Health (BEST?)
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|ClinicalTrials.gov Identifier: NCT01485510|
Recruitment Status : Recruiting
First Posted : December 5, 2011
Last Update Posted : June 11, 2014
|Condition or disease||Intervention/treatment||Phase|
|Maltreated Infants.||Behavioral: GIFT Behavioral: FACS||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Evaluation of the New Orleans Intervention for Infant Mental Health in Glasgow|
|Study Start Date :||December 2011|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||June 2020|
Experimental: Glasgow Infant and Family Team (GIFT)
A service developed by Charles Zeanah and colleagues in New Orleans, that aims to improve the mental health of maltreated infants.
An attachment-based assessment, then a tailored intervention aimed at maximising the chances of a maltreated child returning to the birth family.
Other Name: New Orleans Intervention
Active Comparator: Family Assessment & Contact Service
A social-work based service that aims to assess maltreated children and make recommendations about their future care.
A social work assessment of family functioning that makes recommendations regarding future placement of a maltreated child.
Other Name: Case Management (Lieberman, 2005).
- Change in score on the Infant-Toddler Social-emotional Assessment (ITSEA) [ Time Frame: Baseline and at 1 year follow-up ]The ITSEA is a well validated parent/carer-completed questionnaire covering a wide range of social and emotional behaviours in infants and preschool children. It has been shown to be sensitive to change in previous intervention research with maltreated children with medium to large effect sizes and has good longitudinal stability.
- The Parent Evaluation of Development (PEDS) [ Time Frame: Baseline and 1 year follow up ]A brief parent-report measure of infant language and other milestones
- The Disturbances of Attachment Interview (DAI) [ Time Frame: Baseline and 1 year follow up ]A measure of attachment disorder.
- The Parent-Infant Global Assessment of Functioning (PIR-GAS) [ Time Frame: Baseline and 1 year follow up ]A video-based assessment of global relationship functioning
- This is My Baby (TIMB) [ Time Frame: Baseline and 1 year Follow up ]A measure of the degree of committment to the child by the caregiver
- The Development and Wellbeing Assessment (DAWBA) [ Time Frame: Baseline and 1 year follow up for children over 2 years. ]A diagnostic intrument generating DSM and ICD psychiatric diagnoses.
- Cognitive assessment [ Time Frame: Baseline and 1 year follow up ]This will be either the Bayley's or the WPPSI depending on the age of the child.
- The Use of Services Questionnaire [ Time Frame: Baseline and 1 year follow up ]This carer-report questionnaire generates service use and costs data for health economic analysis
- The Strange Situation Procedure (SSP) [ Time Frame: 1 year follow up only ]This is the gold standard measure for infant/toddler attachment patterns.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01485510
|Contact: Helen Minnis, MBChB, PhD||+44 141 201 firstname.lastname@example.org|
|Contact: Philip Wilson, MD, PhD||+44 141 201 email@example.com|
|University of Glasgow||Recruiting|
|Glasgow, United Kingdom, G3 8SJ|
|Principal Investigator: Helen Minnis|
|Sub-Investigator: Philip Wilson|
|Sub-Investigator: John Norrie|
|Sub-Investigator: Charles Zeanah|
|Sub-Investigator: Julie Larrieu|
|Sub-Investigator: Graham Bryce|
|Sub-Investigator: Julia Donaldson|
|Sub-Investigator: Claudia-Martina Messow|
|Sub-Investigator: Kathleen Boyd|
|Sub-Investigator: Julie Taylor|
|Sub-Investigator: Nicholas Watson|
|Principal Investigator:||Helen Minnis, MBChB, PhD||University of Glasgow|
|Study Chair:||Niel Campbell, MBChB, PhD||University of Aberdeen|