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Effectiveness and Cost-effectiveness of the New Orleans Intervention Model for Infant Mental Health (BeST?-)

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ClinicalTrials.gov Identifier: NCT02653716
Recruitment Status : Not yet recruiting
First Posted : January 12, 2016
Last Update Posted : November 4, 2016
Sponsor:
Collaborators:
University of Glasgow
National Institute for Health Research, United Kingdom
King's College London
Glasgow City Council Social Work
National Society for the Prevention of Cruelty to Children
NHS Greater Glasgow and Clyde
University of Aberdeen
Information provided by (Responsible Party):
Helen Minnis, University of Glasgow

December 23, 2015
January 12, 2016
November 4, 2016
November 2016
December 2019   (Final data collection date for primary outcome 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. [ Time Frame: 30 months after the last participant has been recruited ]
Same as current
Complete list of historical versions of study NCT02653716 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
  • To establish if NIM in relation to CM is effective in improving 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 ]
  • To establish if NIM in relation to CM is cost effective in improving 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 ]
Not Provided
Not Provided
 
Effectiveness and Cost-effectiveness of the New Orleans Intervention Model for Infant Mental Health
BeST?- The Best Services Trial (BeST?): 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) .

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 6 months 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 are currently conducting detailed exploratory work in two potential additional sites, South London and Fife/Tayside, 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 (462 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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Health Services Research
  • Maltreatment
  • Mental Health
  • Behavioral: 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
  • Behavioral: Case Management
    A social work assessment of family functioning that makes future recommendations regarding the future placement of a maltreated child.
  • Active Comparator: Case Management
    CM
    Intervention: Behavioral: Case Management
  • Experimental: New Orleans Intervention Model
    NIM
    Intervention: Behavioral: New Orleans Intervention Method
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
462
Same as current
December 2020
December 2019   (Final data collection date for primary outcome measure)

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).
Sexes Eligible for Study: All
up to 60 Months   (Child)
No
Contact: Lynn Mcmahon 0141 201 9239 ext 9239 lynn.mcmahon@glasgow.ac.uk
Contact: Paul Dearie 0141-232-1810 ext 1810 paul.dearie@ggc.scot.nhs.uk
Not Provided
 
 
NCT02653716
GN14CO183
Yes
Not Provided
Not Provided
Helen Minnis, University of Glasgow
Helen Minnis
  • University of Glasgow
  • National Institute for Health Research, United Kingdom
  • King's College London
  • Glasgow City Council Social Work
  • National Society for the Prevention of Cruelty to Children
  • NHS Greater Glasgow and Clyde
  • University of Aberdeen
Principal Investigator: Helen Minnis University of Glasgow
University of Glasgow
November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP