MaltreatmentBeST?-NCT02653716
Effectiveness and Cost-effectiveness of the New Orleans Intervention Model for Infant Mental Health
A study testing New Orleans Intervention Method and Case Management in people with Maltreatment and Mental Health, run by Helen Minnis at 2 sites in United Kingdom.
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) . Read more about this study
- Who is it for?
- Ages 0 to 60 months
- Conditions the study is for
- Maltreatment, Mental Health
- What is being tested?
- New Orleans Intervention Method and Case Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 384 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 29 Aug 2017to 8 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 60 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
University of Glasgow
Glasgow
Kings College London
London
About this study
Official title: 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) .
Read the detailed 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.
- Conditions
- Maltreatment, Mental Health
- Being tested
- New Orleans Intervention Method, Case Management
- Keywords
- New Orleans Intervention Model, Case Management, Maltreatment, Child
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New Orleans Intervention MethodBehavioural
An attachment based assessment, then a tailored intervention aimed at maximising the chances of the maltreated child being returned to the birth family
Case ManagementBehavioural
A social work assessment of family functioning that makes future recommendations regarding the future placement of a maltreated child.
| Study group | Role | What they receive |
|---|---|---|
| Case Management | Active comparator | CM Receives: Behavioral: Case Management |
| New Orleans Intervention Model | Experimental | NIM Receives: Behavioral: New Orleans Intervention Method |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)"
Measured: 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)
Measured: 30 months after the last participant has been recruited
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2016 (estimated)
- Study start29 Aug 2017
- Primary completion8 Dec 2023
- Study completion8 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MaltreatmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 384 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helen Minnis
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor-investigator, Helen Minnis, University of Glasgow
- Investigators
- Helen Minnis, Principal investigator, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02653716
- Sponsor's protocol ID
- GN14CO183
- Acronym
- BeST?-
- Status last verified
- May 2024
- First submitted
- 23 Dec 2015
- Last updated
- 3 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40312587Deidda 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.
PubMed 29540420
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BeST?- The Best Services Trial (BeST?): Effectiveness and Cost-effectiveness of the New Orleans Intervention Model for Infant Mental Health
- ClinicalTrials.gov ID
- NCT02653716
- Acronym / sponsor ID
- BeST?- / GN14CO183
- Conditions
- Maltreatment, Mental Health
- Keywords
- New Orleans Intervention Model, Case Management, Maltreatment, Child
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 384 participants (actual)
- Lead sponsor
- Helen MinnisUniversity, hospital or other
- 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
- Study start
- 29 Aug 2017 (actual)
- Primary completion
- 8 Dec 2023 (actual)
- Study completion
- 8 Dec 2023 (actual)
- First posted
- 12 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case Management | Active comparator | Behavioral: Case ManagementCM |
| New Orleans Intervention Model | Experimental | Behavioral: New Orleans Intervention MethodNIM |
Who may qualify
- Ages
- 0 to 60 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| New Orleans Intervention MethodAn attachment based assessment, then a tailored intervention aimed at maximising the chances of the maltreated child being returned to the birth family | Behavioural | New Orleans Intervention Model |
| Case ManagementA social work assessment of family functioning that makes future recommendations regarding the future placement of a maltreated child. | Behavioural | Case Management |
Primary outcome
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
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2024.
- Derived from this study: PubMed 40312587Crawford 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.
- Derived from this study: PubMed 29540420Deidda 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helen Minnis principal investigator
University of Glasgow
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing New Orleans Intervention Method and Case Management in people with Maltreatment and Mental Health, run by Helen Minnis at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02653716, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2024.