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Evaluation of the New Orleans Intervention for Infant Mental Health (BEST?)

This study is currently recruiting participants.
Verified March 2012 by University of Glasgow
Sponsor:
Information provided by (Responsible Party):
Helen Minnis, University of Glasgow
ClinicalTrials.gov Identifier:
NCT01485510
First received: November 30, 2011
Last updated: March 9, 2012
Last verified: March 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Maltreated Infants.
 Behavioral: GIFT
Behavioral: FACS
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Evaluation of the New Orleans Intervention for Infant Mental Health in Glasgow

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Glasgow:

Primary Outcome Measures:
  • Change in score on the Infant-Toddler Social-emotional Assessment (ITSEA) [ Time Frame: Baseline and at 1 year follow-up ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • The Parent Evaluation of Development (PEDS) [ Time Frame: Baseline and 1 year follow up ] [ Designated as safety issue: No ]
    A brief parent-report measure of infant language and other milestones

  • The Disturbances of Attachment Interview (DAI) [ Time Frame: Baseline and 1 year follow up ] [ Designated as safety issue: No ]
    A measure of attachment disorder.

  • The Parent-Infant Global Assessment of Functioning (PIR-GAS) [ Time Frame: Baseline and 1 year follow up ] [ Designated as safety issue: No ]
    A video-based assessment of global relationship functioning

  • This is My Baby (TIMB) [ Time Frame: Baseline and 1 year Follow up ] [ Designated as safety issue: No ]
    A measure of the degree of committment to the child by the caregiver

  • The Development and Wellbeing Assessment (DAWBA) [ Time Frame: Baseline and 1 year follow up for children over 2 years. ] [ Designated as safety issue: No ]
    A diagnostic intrument generating DSM and ICD psychiatric diagnoses.

  • Cognitive assessment [ Time Frame: Baseline and 1 year follow up ] [ Designated as safety issue: No ]
    This will be either the Bayley's or the WPPSI depending on the age of the child.

  • The Use of Services Questionnaire [ Time Frame: Baseline and 1 year follow up ] [ Designated as safety issue: No ]
    This carer-report questionnaire generates service use and costs data for health economic analysis

  • The Strange Situation Procedure (SSP) [ Time Frame: 1 year follow up only ] [ Designated as safety issue: No ]
    This is the gold standard measure for infant/toddler attachment patterns.


Estimated Enrollment: 100
Study Start Date: December 2011
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Glasgow Infant and Family Team (GIFT)
A service developed by Charles Zeanah and colleagues in New Orleans, that aims to improve the mental health of maltreated infants.
 Behavioral: GIFT
An attachment-based assessment, then a tailored intervention aimed at maximising the chances of a maltreated child returning to the birth family.
Other Name: New Orleans Intervention
Active Comparator: Family Assessment & Contact Service
A social-work based service that aims to assess maltreated children and make recommendations about their future care.
 Behavioral: FACS
A social work assessment of family functioning that makes recommendations regarding future placement of a maltreated child.
Other Name: Case Management (Lieberman, 2005).

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

Ages Eligible for Study:   6 Months to 60 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01485510

Contacts
Contact: Helen Minnis, MBChB, PhD +44 141 201 9239 helen.minnis@glasgow.ac.uk
Contact: Philip Wilson, MD, PhD +44 141 201 9239 philip.wilson@glasgow.ac.uk

Locations
United Kingdom
University of Glasgow Recruiting
Glasgow, United Kingdom, G3 8SJ
Principal Investigator: Helen Minnis            
Sub-Investigator: Philip Wilson            
Sub-Investigator: John Norrie            
Sub-Investigator: Charles Zeanah            
Sub-Investigator: Julie Larrieu            
Sub-Investigator: Graham Bryce            
Sub-Investigator: Julia Donaldson            
Sub-Investigator: Claudia-Martina Messow            
Sub-Investigator: Kathleen Boyd            
Sub-Investigator: Julie Taylor            
Sub-Investigator: Nicholas Watson            
Sponsors and Collaborators
University of Glasgow
Investigators
Principal Investigator: Helen Minnis, MBChB, PhD University of Glasgow
Study Chair: Niel Campbell, MBChB, PhD University of Aberdeen
  More Information

No publications provided

Responsible Party: Helen Minnis, Principal Investigator, University of Glasgow
ClinicalTrials.gov Identifier: NCT01485510     History of Changes
Other Study ID Numbers: CZH/4/629
Study First Received: November 30, 2011
Last Updated: March 9, 2012
Health Authority: United Kingdom: National Health Service

Keywords provided by University of Glasgow:
Maltreatment
Infant Mental Health
Infant mental health in maltreated children

ClinicalTrials.gov processed this record on May 23, 2013