Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02653716 |
| Other study ID # |
GN14CO183 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 29, 2017 |
| Est. completion date |
December 8, 2023 |
Study information
| Verified date |
May 2024 |
| Source |
University of Glasgow |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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) .
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.
