Evaluation of the New Orleans Intervention for Infant Mental Health

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Evaluation of the New Orleans Intervention for Infant Mental Health in Glasgow

Conditions
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Maltreated Infants

Intervention / Treatment
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* Behavioral: GIFT
* Behavioral: FACS


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 60 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Glasgow Infant and Family Team (GIFT)<br>A service developed by Charles Zeanah and colleagues in New Orleans, that aims to improve the mental health of maltreated infants. | Behavioral: GIFT<br>* An attachment-based assessment, then a tailored intervention aimed at maximising the chances of a maltreated child returning to the birth family.<br>* Other names: New Orleans Intervention;|
| Active Comparator: Family Assessment & Contact Service<br>A social-work based service that aims to assess maltreated children and make recommendations about their future care. | Behavioral: FACS<br>* A social work assessment of family functioning that makes recommendations regarding future placement of a maltreated child.<br>* Other names: Case Management (Lieberman, 2005).;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in score on the Infant-Toddler Social-emotional Assessment (ITSEA) | 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. | Baseline and at 1 year follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Parent Evaluation of Development (PEDS) | A brief parent-report measure of infant language and other milestones | Baseline and 1 year follow up | 
| The Disturbances of Attachment Interview (DAI) | A measure of attachment disorder. | Baseline and 1 year follow up | 
| The Parent-Infant Global Assessment of Functioning (PIR-GAS) | A video-based assessment of global relationship functioning | Baseline and 1 year follow up | 
| This is My Baby (TIMB) | A measure of the degree of committment to the child by the caregiver | Baseline and 1 year Follow up | 
| The Development and Wellbeing Assessment (DAWBA) | A diagnostic intrument generating DSM and ICD psychiatric diagnoses. | Baseline and 1 year follow up for children over 2 years. | 
| Cognitive assessment | This will be either the Bayley's or the WPPSI depending on the age of the child. | Baseline and 1 year follow up | 
| The Use of Services Questionnaire | This carer-report questionnaire generates service use and costs data for health economic analysis | Baseline and 1 year follow up | 
| The Strange Situation Procedure (SSP) | This is the gold standard measure for infant/toddler attachment patterns. | 1 year follow up only | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Maltreatment, Infant Mental Health, Infant mental health in maltreated children