NCT02653716

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) .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
384

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 23, 2015

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 12, 2016

Completed
1.6 years until next milestone

Study Start

First participant enrolled

August 29, 2017

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 8, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 8, 2023

Completed
Last Updated

June 3, 2024

Status Verified

May 1, 2024

Enrollment Period

6.3 years

First QC Date

December 23, 2015

Last Update Submit

May 31, 2024

Conditions

MaltreatmentMental Health

Keywords

New Orleans Intervention ModelCase ManagementMaltreatmentChild

Outcome Measures

Primary Outcomes (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.

    A brief behavioural screening questionnaire for 2-17 year-olds completed by the primary caregiver with 25 items in 5 subscales: emotional symptoms; conduct problems; hyperactivity/inattention; peer relationship problems and prosocial behaviour

    30 months after the last participant has been recruited

Secondary Outcomes (2)

  • 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)"

    30 months after the last participant has been recruited

  • Quality of life by reviewing the PedsQL - a measure of child quality of life to look at Quality Adjusted Life Years (QALYs)

    30 months after the last participant has been recruited

Study Arms (2)

Case Management

ACTIVE COMPARATOR

CM

Behavioral: Case Management

New Orleans Intervention Model

EXPERIMENTAL

NIM

Behavioral: New Orleans Intervention Method

Interventions

New Orleans Intervention MethodBEHAVIORAL

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

New Orleans Intervention Model
Case ManagementBEHAVIORAL

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

Case Management

Eligibility Criteria

Age0 Months - 60 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Glasgow

Glasgow, United Kingdom

Location

Kings College London

London, United Kingdom

Location

Related Publications (2)

  • 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.

    PMID: 40312587DERIVED

  • 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.

    PMID: 29540420DERIVED

MeSH Terms

Conditions

Psychological Well-Being

Interventions

Case Management

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Intervention Hierarchy (Ancestors)

Patient Care PlanningComprehensive Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Helen Minnis

    University of Glasgow

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Child and Adolescent Psychiatry

Study Record Dates

First Submitted

December 23, 2015

First Posted

January 12, 2016

Study Start

August 29, 2017

Primary Completion

December 8, 2023

Study Completion

December 8, 2023

Last Updated

June 3, 2024

Record last verified: 2024-05

Locations

GB(2)