Effectiveness and Cost-effectiveness of the New Orleans Intervention Model for Infant Mental Health

NCT ID: NCT02653716

Last Updated: 2024-06-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

384 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-29

Study Completion Date

2023-12-08

Brief Summary

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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

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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.

Conditions

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Maltreatment Mental Health

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Investigators

Study Groups

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Case Management

CM

Group Type ACTIVE_COMPARATOR

Case Management

Intervention Type BEHAVIORAL

A social work assessment of family functioning that makes future recommendations regarding the future placement of a maltreated child.

New Orleans Intervention Model

NIM

Group Type EXPERIMENTAL

New Orleans Intervention Method

Intervention Type BEHAVIORAL

An attachment based assessment, then a tailored intervention aimed at maximising the chances of the maltreated child being returned to the birth family

Interventions

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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

Intervention Type BEHAVIORAL

Case Management

A social work assessment of family functioning that makes future recommendations regarding the future placement of a maltreated child.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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).
Minimum Eligible Age

0 Months

Maximum Eligible Age

60 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Glasgow

OTHER

Sponsor Role collaborator

National Institute for Health Research, United Kingdom

OTHER_GOV

Sponsor Role collaborator

King's College London

OTHER

Sponsor Role collaborator

Glasgow City Council Social Work

UNKNOWN

Sponsor Role collaborator

National Society for the Prevention of Cruelty to Children

OTHER

Sponsor Role collaborator

NHS Greater Glasgow and Clyde

OTHER

Sponsor Role collaborator

University of Aberdeen

OTHER

Sponsor Role collaborator

Helen Minnis

OTHER

Sponsor Role lead

Responsible Party

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Helen Minnis

Professor of Child and Adolescent Psychiatry

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Helen Minnis

Role: PRINCIPAL_INVESTIGATOR

University of Glasgow

Locations

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University of Glasgow

Glasgow, , United Kingdom

Site Status

Kings College London

London, , United Kingdom

Site Status

Countries

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United Kingdom

References

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Crawford K, Young R, Wilson P, Deidda M, Forde M, Millar S, McConnachie A, Boyd K, McIntosh E, Ougrin D, Henderson M, Gillberg C, Kainth G, Turner F, Sonuga-Barke EJS, Fitzpatrick B, Minnis H. Infant mental health services for birth and foster families of maltreated pre-school children in foster care (BeST?): a cluster-randomized phase 3 clinical effectiveness trial. Nat Med. 2025 May;31(5):1617-1625. doi: 10.1038/s41591-025-03534-9. Epub 2025 May 1.

Reference Type DERIVED
PMID: 40312587 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29540420 (View on PubMed)

Other Identifiers

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GN14CO183

Identifier Type: -

Identifier Source: org_study_id

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