Clinical trial NCT01485510: Evaluation of the New Orleans Intervention for Infant Mental Health
Official title: Evaluation of the New Orleans Intervention for Infant Mental Health in Glasgow
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Maltreated Infants
Keywords: Maltreatment
Infant Mental Health
Infant mental health in maltreated children
Lead sponsor: University of Glasgow
Sponsor class: OTHER
First posted: 2011-12-05
Enrollment: 227
Sex: ALL
Minimum age (years): 6
Maximum age (years): 60
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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 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

Primary outcomes:
measure: Change in score on the Infant-Toddler Social-emotional Assessment (ITSEA)
timeFrame: Baseline and at 1 year follow-up
Secondary outcomes:
measure: The Parent Evaluation of Development (PEDS)
timeFrame: Baseline and 1 year follow up
measure: The Disturbances of Attachment Interview (DAI)
timeFrame: Baseline and 1 year follow up
measure: The Parent-Infant Global Assessment of Functioning (PIR-GAS)
timeFrame: Baseline and 1 year follow up
measure: This is My Baby (TIMB)
timeFrame: Baseline and 1 year Follow up
measure: The Development and Wellbeing Assessment (DAWBA)
timeFrame: Baseline and 1 year follow up for children over 2 years.
measure: Cognitive assessment
timeFrame: Baseline and 1 year follow up
measure: The Use of Services Questionnaire
timeFrame: Baseline and 1 year follow up
measure: The Strange Situation Procedure (SSP)
timeFrame: 1 year follow up only
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: University of Glasgow
Study officials:
affiliation: University of Glasgow
name: Helen Minnis, MBChB, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Aberdeen
name: Niel Campbell, MBChB, PhD
role: STUDY_CHAIR
References: