Clinical trial NCT02653716: Effectiveness and Cost-effectiveness of the New Orleans Intervention Model for Infant Mental Health
Official title: BeST?- The Best Services Trial (BeST?): Effectiveness and Cost-effectiveness of the New Orleans Intervention Model for Infant Mental Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Maltreatment
Mental Health
Keywords: New Orleans Intervention Model
Case Management
Maltreatment
Child
Lead sponsor: University of Glasgow
Sponsor class: OTHER
Collaborators: name: University of Glasgow
name: National Institute for Health Research, United Kingdom
name: King's College London
name: Glasgow City Council Social Work
name: National Society for the Prevention of Cruelty to Children
name: NHS Greater Glasgow and Clyde
name: University of Aberdeen
First posted: 2016-01-12
Enrollment: 384
Sex: ALL
Minimum age (years): 0
Maximum age (years): 60
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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) .

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 0 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 added an additional site, London, 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 (396 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.

Eligibility criteria: 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).

Primary outcomes:
measure: 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.
timeFrame: 30 months after the last participant has been recruited
Secondary outcomes:
measure: 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)"
timeFrame: 30 months after the last participant has been recruited
measure: Quality of life by reviewing the PedsQL - a measure of child quality of life to look at Quality Adjusted Life Years (QALYs)
timeFrame: 30 months after the last participant has been recruited
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: University of Glasgow
city: London
country: United Kingdom
facility: Kings College London
Study officials:
affiliation: University of Glasgow
name: Helen Minnis
role: PRINCIPAL_INVESTIGATOR
References:
citation: Deidda M, Boyd KA, Minnis H, Donaldson J, Brown K, Boyer NRS, McIntosh E; BeST study team. Protocol for the economic evaluation of a complex intervention to improve the mental health of maltreated infants and children in foster care in the UK (The BeST? services trial). BMJ Open. 2018 Mar 14;8(3):e020066. doi: 10.1136/bmjopen-2017-020066.