Evaluation of the New Orleans Intervention for Infant Mental Health

NCT01485510 | Completed

• 1 other identifier: CZH/4/629
• Study Type: interventional
• Target: 227
• Locations: 1 country
• Sites: 1

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.

Conditions

Maltreated Infants

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• The Parent Evaluation of Development (PEDS)

  Baseline and 1 year follow up

• The Disturbances of Attachment Interview (DAI)

  Baseline and 1 year follow up

• The Parent-Infant Global Assessment of Functioning (PIR-GAS)

  Baseline and 1 year follow up

• This is My Baby (TIMB)

  Baseline and 1 year Follow up

• The Development and Wellbeing Assessment (DAWBA)

  Baseline and 1 year follow up for children over 2 years.

Study Arms (2)

Glasgow Infant and Family Team (GIFT)

EXPERIMENTAL

A service developed by Charles Zeanah and colleagues in New Orleans, that aims to improve the mental health of maltreated infants.

Behavioral: GIFT

Family Assessment & Contact Service

ACTIVE COMPARATOR

A social-work based service that aims to assess maltreated children and make recommendations about their future care.

Behavioral: FACS

Interventions

GIFT BEHAVIORAL

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

Also known as: New Orleans Intervention

Glasgow Infant and Family Team (GIFT)

FACS BEHAVIORAL

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

Also known as: Case Management (Lieberman, 2005).

Family Assessment & Contact Service

Eligibility Criteria

• Age: 6 Months - 60 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• All maltreated children placed in foster care, aged between 6 and 60 months, whose parents give informed opt-in consent

You may not qualify if:

• Children with profound learning disability

Sponsors & Collaborators

• University of Glasgow: lead

Study Sites (1)

University of Glasgow

Glasgow, G3 8SJ, United Kingdom

Location

MeSH Terms

Interventions

Case Management

Intervention Hierarchy (Ancestors)

Patient Care Planning; Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• Helen Minnis, MBChB, PhD

  University of Glasgow

  PRINCIPAL INVESTIGATOR

• Niel Campbell, MBChB, PhD

  University of Aberdeen

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 30, 2011
• First Posted: December 5, 2011
• Study Start: December 1, 2011
• Primary Completion: August 28, 2017
• Study Completion: August 28, 2017
• Last Updated: June 4, 2024

Record last verified: 2024-06

Locations

GB (1)