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Evaluation of the New Orleans Intervention for Infant Mental Health (BEST?)
This study is currently recruiting participants.
Verified June 2014 by Helen Minnis, University of Glasgow
Sponsor:
University of Glasgow
Information provided by (Responsible Party):
Helen Minnis, University of Glasgow
ClinicalTrials.gov Identifier:
NCT01485510
First received: November 30, 2011
Last updated: June 10, 2014
Last verified: June 2014
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Purpose
Early intervention for maltreated infants can improve mental and physical health throughout life and benefit families and society as a whole. The New Orleans Model provides intensive assessment and treatment for families of maltreated preschool children in foster care, with recommendations to court about adoption, or permanent return to birth families. The New Orleans Model appears to have led to better informed decisions about permanent placement and to better child mental health in Louisiana. The investigators propose an exploratory randomised controlled trial investigating the effectiveness of the New Orleans Model in the Scottish context, informing the development of an economic model to explore the potential cost-effectiveness. Families with a maltreated child under 5 years of age will be offered the New Orleans Model or "case management" i.e. quality assured services as usual, using random allocation. The investigators will measure outcome using well validated measures of parent-child interaction, cognition and attachment.
| Condition | Intervention | Phase |
|---|---|---|
| Maltreated Infants. | Behavioral: GIFT Behavioral: FACS | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Evaluation of the New Orleans Intervention for Infant Mental Health in Glasgow |
Resource links provided by NLM:
Further study details as provided by Helen Minnis, University of Glasgow:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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.
| Estimated Enrollment: | 100 |
| Study Start Date: | December 2011 |
| Estimated Study Completion Date: | June 2020 |
| Estimated Primary Completion Date: | June 2020 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Behavioral: GIFT
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.
|
Behavioral: FACS
A social work assessment of family functioning that makes recommendations regarding future placement of a maltreated child.
Other Name: Case Management (Lieberman, 2005).
|
Detailed Description:
The first 5 months of this trial - from December 2011 to April 2012 - is an internal pilot or "implementation period". During this time we have fewer research staff, both services will just have started and we will only be collecting selected outcome measures. These will be the Principle Outcome Measure, the Infant-Toddler Social-Emotional Assessment (ITSEA), plus the Disturbance of Attachment Interview (DAI) and Parent-Infant Global Assessment of Functioning (PIR-GAS). We hope to include data from implementation period in our trial analysis, but if results are very different due to services "bedding in", we may not do so
Eligibility| Ages Eligible for Study: | 6 Months to 60 Months (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- All maltreated children placed in foster care, aged between 6 and 60 months, whose parents give informed opt-in consent
Exclusion Criteria:
- Children with profound learning disability
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01485510
Please refer to this study by its ClinicalTrials.gov identifier: NCT01485510
Contacts
| Contact: Helen Minnis, MBChB, PhD | +44 141 201 9239 | helen.minnis@glasgow.ac.uk | |
| Contact: Philip Wilson, MD, PhD | +44 141 201 9239 | philip.wilson@glasgow.ac.uk |
Locations
| United Kingdom | |
| 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 | |
Sponsors and Collaborators
University of Glasgow
Investigators
| Principal Investigator: | Helen Minnis, MBChB, PhD | University of Glasgow |
| Study Chair: | Niel Campbell, MBChB, PhD | University of Aberdeen |
More Information
| Responsible Party: | Helen Minnis, Principal Investigator, University of Glasgow |
| ClinicalTrials.gov Identifier: | NCT01485510 History of Changes |
| Other Study ID Numbers: |
CZH/4/629 |
| Study First Received: | November 30, 2011 |
| Last Updated: | June 10, 2014 |
Keywords provided by Helen Minnis, University of Glasgow:
|
Maltreatment Infant Mental Health Infant mental health in maltreated children |
ClinicalTrials.gov processed this record on July 28, 2017