Skip to main content
OpenTrials
Completed

NCT Number: NCT01485510

Evaluation of the New Orleans Intervention for Infant Mental Health

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

6 month–60 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Glasgow

Glasgow, G3 8SJ, United Kingdom

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GIFT

Behavioral

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

Other names: New Orleans Intervention

FACS

Behavioral

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

Other names: Case Management (Lieberman, 2005).

Primary outcomes

  1. 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 outcomes

  1. 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

  2. The Disturbances of Attachment Interview (DAI)

    Time frame: Baseline and 1 year follow up

    A measure of attachment disorder.

  3. 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

  4. 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

  5. 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.

  6. 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.

  7. 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

  8. The Strange Situation Procedure (SSP)

    Time frame: 1 year follow up only

    This is the gold standard measure for infant/toddler attachment patterns.

Sponsors and collaborators

Lead sponsor

University of Glasgow

Other

Registry information

Official study title

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

Acronym: BEST?

Important dates

Study start
2011
Primary completion
2017
Study completion
2017
First posted
Dec 5, 2011
Registry last updated
Jun 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.