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Evaluation of the New Orleans Intervention for Infant Mental Health

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01485510
Acronym
BEST?
Enrollment
227
Registered
2011-12-05
Start date
2011-12-31
Completion date
2017-08-28
Last updated
2024-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Maltreated Infants

Keywords

Maltreatment, Infant Mental Health, Infant mental health in maltreated children

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

Interventions

BEHAVIORALGIFT

An attachment-based assessment, then a tailored intervention aimed at maximising the chances of a maltreated child returning to the birth family.

BEHAVIORALFACS

A social work assessment of family functioning that makes recommendations regarding future placement of a maltreated child.

Sponsors

University of Glasgow
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
6 Months to 60 Months
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in score on the Infant-Toddler Social-emotional Assessment (ITSEA)Baseline and at 1 year follow-upThe 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

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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026