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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01485510
Recruitment Status : Recruiting
First Posted : December 5, 2011
Last Update Posted : June 11, 2014
Information provided by (Responsible Party):
Helen Minnis, University of Glasgow

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.

Condition or disease Intervention/treatment Phase
Maltreated Infants. Behavioral: GIFT Behavioral: FACS Phase 2

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Evaluation of the New Orleans Intervention for Infant Mental Health in Glasgow
Study Start Date : December 2011
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Health

Arm Intervention/treatment
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).

Primary Outcome Measures :
  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 Outcome Measures :
  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.

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 60 Months   (Child)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01485510

Contact: Helen Minnis, MBChB, PhD +44 141 201 9239
Contact: Philip Wilson, MD, PhD +44 141 201 9239

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
Principal Investigator: Helen Minnis, MBChB, PhD University of Glasgow
Study Chair: Niel Campbell, MBChB, PhD University of Aberdeen

Responsible Party: Helen Minnis, Principal Investigator, University of Glasgow Identifier: NCT01485510     History of Changes
Other Study ID Numbers: CZH/4/629
First Posted: December 5, 2011    Key Record Dates
Last Update Posted: June 11, 2014
Last Verified: June 2014

Keywords provided by Helen Minnis, University of Glasgow:
Infant Mental Health
Infant mental health in maltreated children