We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Effectiveness and Cost-effectiveness of the New Orleans Intervention Model 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.
ClinicalTrials.gov Identifier: NCT02653716
Recruitment Status : Not yet recruiting
First Posted : January 12, 2016
Last Update Posted : November 4, 2016
Information provided by (Responsible Party):

Study Description
Brief Summary:
To evaluate the clinical and cost-effectiveness of the New Orleans Intervention Method (NIM) in relation to an enhanced services as usual model, Case Management (CM), for the management of maltreated infants and young children entering care in the United Kingdom (UK) .

Condition or disease Intervention/treatment Phase
Maltreatment Mental Health Behavioral: New Orleans Intervention Method Behavioral: Case Management Phase 3

Detailed Description:

Children who have experienced abuse and neglect are at increased risk of mental and physical health problems throughout life. This places an enormous burden on individuals, families and society. Regardless of the severity of this abuse and neglect, these negative effects can largely be reversed if children are placed in secure, loving homes early enough in life. Placing children in nurturing foster placements can help them recover rapidly, but it is not known whether it is better for children's long term development to place them with substitute (foster or adoptive) families or return them to birth or extended families. Efforts to improve the mental health of maltreated children in birth families or foster placements have had mixed success and researchers have recommended that far more intensive approaches are required.

The investigators have carried out careful exploratory research, in Glasgow, on an intensive approach, which was developed in the United States. This is was investigators have called this the New Orleans Intervention Model (NIM). NIM offers families who have a child who enters care due to abuse or neglect a structured assessment of family relationships followed by an intensive treatment that aims to improve family functioning and child mental health. If adequate change is achieved a recommendation is made for the child to return home but, if not, the recommendation is for adoption. Preliminary research from the US suggests that NIM might reduce future maltreatment of the child and other children in the family, and improve mental health in middle childhood.

The investigators are currently conducting a study in which, since December 2011, has recruited around two-thirds of all maltreated children aged 6 months to 5 years coming into an episode of care in Glasgow. Half of the families who are taking part receive NIM, which is delivered by a multidisciplinary team comprising health and social care professionals. The remaining half of families will receive usual services, which is delivered by social workers. Preliminary findings suggest that NIM is acceptable to parents, foster carers, social workers and legal professionals. Investigators are currently conducting detailed exploratory work in two potential additional sites, South London and Fife/Tayside, as there is a need to test whether NIM is effective, in terms of both clinical outcomes and cost, in the different legal systems across England and Scotland. The plan is to launch NIM teams at these sites in 2016.

The Investigators, therefore, propose a study of NIM involving a continuation of our current Glasgow work and including 1-2 additional sites. This will involve approximately 500 children (462 families) in total across the sites, including those recruited in our current Glasgow internal pilot study. This will determine whether or not NIM is effective in the UK and to follow up Glasgow children for five years to examine longer term effects on mental health.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 462 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Health Services Research
Official Title: BeST?- The Best Services Trial (BeST?): Effectiveness and Cost-effectiveness of the New Orleans Intervention Model for Infant Mental Health
Study Start Date : November 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Health
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Case Management
Behavioral: Case Management
A social work assessment of family functioning that makes future recommendations regarding the future placement of a maltreated child.
Experimental: New Orleans Intervention Model
Behavioral: New Orleans Intervention Method
An attachment based assessment, then a tailored intervention aimed at maximising the chances of the maltreated child being returned to the birth family

Outcome Measures

Primary Outcome Measures :
  1. Child mental health measured by the Total Difficulties scale of the strengths and difficulties questionnaire to establish if NIM in relation to CM is effective in improving child mental health as evidenced by reduced scores. [ Time Frame: 30 months after the last participant has been recruited ]

Secondary Outcome Measures :
  1. Improvement in the relationship between the primary caregiver and the maltreated child as evidenced by increased scores on the Parent-Infant Global Assessment Scale (PIR-GAS)" [ Time Frame: 30 months after the last participant has been recruited ]
  2. Quality of life by reviewing the PedsQL - a measure of child quality of life to look at Quality Adjusted Life Years (QALYs) [ Time Frame: 30 months after the last participant has been recruited ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   up to 60 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Family with a child aged 0-60 months who enters care in the recruiting sites for reasons associated with maltreatment during the study recruitment period.

Exclusion Criteria:

  • Families will be excluded from the trial if the parent(s) is unavailable to take part in intervention (e.g. because of death, unknown whereabouts or long term imprisonment).
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT02653716

Contact: Lynn Mcmahon 0141 201 9239 ext 9239 lynn.mcmahon@glasgow.ac.uk
Contact: Paul Dearie 0141-232-1810 ext 1810 paul.dearie@ggc.scot.nhs.uk

Sponsors and Collaborators
Helen Minnis
University of Glasgow
National Institute for Health Research, United Kingdom
King's College London
Glasgow City Council Social Work
National Society for the Prevention of Cruelty to Children
NHS Greater Glasgow and Clyde
University of Aberdeen
Principal Investigator: Helen Minnis University of Glasgow
More Information

Responsible Party: Helen Minnis, Professor of Child and Adolescent Psychiatry, University of Glasgow
ClinicalTrials.gov Identifier: NCT02653716     History of Changes
Other Study ID Numbers: GN14CO183
First Posted: January 12, 2016    Key Record Dates
Last Update Posted: November 4, 2016
Last Verified: November 2016

Keywords provided by Helen Minnis, University of Glasgow:
New Orleans Intervention Model
Case Management