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Completed

NCT Number: NCT02653716

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

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) .

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Key information

Age range

0 month–60 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Glasgow, Glasgow, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

New Orleans Intervention Method

Behavioral

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

Case Management

Behavioral

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

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.

    Time frame: 30 months after the last participant has been recruited

    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

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Helen Minnis

Other

Collaborators

  • Glasgow City Council Social Work
  • King's College London
  • NHS Greater Glasgow and Clyde
  • National Institute for Health Research, United Kingdom
  • National Society for the Prevention of Cruelty to Children
  • University of Aberdeen
  • University of Glasgow

Registry information

Official study title

BeST?- The Best Services Trial (BeST?): Effectiveness and Cost-effectiveness of the New Orleans Intervention Model for Infant Mental Health

Acronym: BeST?-

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
Jan 12, 2016
Registry last updated
Jun 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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