Maltreated InfantsBEST?NCT01485510
Evaluation of the New Orleans Intervention for Infant Mental Health
A study testing GIFT and FACS in people with Maltreated Infants, run by University of Glasgow at 1 site in United Kingdom.
Trial summary
Early intervention for maltreated infants can improve mental and physical health throughout life and benefit families and society as a whole. The New Orleans Model provides intensive assessment and treatment for families of maltreated preschool children in foster care, with recommendations to court about adoption, or… Read more about this study
- Who is it for?
- Ages 6 to 60 months
- Conditions the study is for
- Maltreated Infants
- What is being tested?
- GIFT and FACS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 227 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2011to 28 Aug 2017
- 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 6 to 60 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All maltreated children placed in foster care, aged between 6 and 60 months, whose parents give informed opt-in consent
Who cannot join
- Children with profound learning disability
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the New Orleans Intervention for Infant Mental Health in Glasgow
Early intervention for maltreated infants can improve mental and physical health throughout life and benefit families and society as a whole. The New Orleans Model provides intensive assessment and treatment for families of maltreated preschool children in foster care, with recommendations to court about adoption, or permanent return to birth families. The New Orleans Model appears to have led to better informed decisions about permanent placement and to better child mental health in Louisiana. The investigators propose an exploratory randomised controlled trial investigating the effectiveness of the New Orleans Model in the Scottish context, informing the development of an economic model to explore the potential cost-effectiveness. Families with a maltreated child under 5 years of age will be offered the New Orleans Model or "case management" i.e. quality assured services as usual, using random allocation. The investigators will measure outcome using well validated measures of parent-child interaction, cognition and attachment.
Read the detailed description
The first 5 months of this trial - from December 2011 to April 2012 - is an internal pilot or "implementation period". During this time we have fewer research staff, both services will just have started and we will only be collecting selected outcome measures. These will be the Principle Outcome Measure, the Infant-Toddler Social-Emotional Assessment (ITSEA), plus the Disturbance of Attachment Interview (DAI) and Parent-Infant Global Assessment of Functioning (PIR-GAS). We hope to include data from implementation period in our trial analysis, but if results are very different due to services "bedding in", we may not do so
- Conditions
- Maltreated Infants
- Being tested
- GIFT, FACS
- Keywords
- Maltreatment, Infant Mental Health, Infant mental health in maltreated children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GIFTBehavioural
Also called New Orleans Intervention
An attachment-based assessment, then a tailored intervention aimed at maximising the chances of a maltreated child returning to the birth family.
FACSBehavioural
Also called Case Management (Lieberman, 2005).
A social work assessment of family functioning that makes recommendations regarding future placement of a maltreated child.
| Study group | Role | What they receive |
|---|---|---|
| Glasgow Infant and Family Team (GIFT) | Experimental | A service developed by Charles Zeanah and colleagues in New Orleans, that aims to improve the mental health of maltreated infants. Receives: Behavioral: GIFT |
| Family Assessment & Contact Service | Active comparator | A social-work based service that aims to assess maltreated children and make recommendations about their future care. Receives: Behavioral: FACS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in score on the Infant-Toddler Social-emotional Assessment (ITSEA)
The ITSEA is a well validated parent/carer-completed questionnaire covering a wide range of social and emotional behaviours in infants and preschool children. It has been shown to be sensitive to change in previous intervention research with maltreated children with medium to large effect sizes and has good longitudinal stability.
Measured: Baseline and at 1 year follow-up
Secondary outcomes (8)
The Parent Evaluation of Development (PEDS)
A brief parent-report measure of infant language and other milestones
Measured: Baseline and 1 year follow up
The Disturbances of Attachment Interview (DAI)
A measure of attachment disorder.
Measured: Baseline and 1 year follow up
The Parent-Infant Global Assessment of Functioning (PIR-GAS)
A video-based assessment of global relationship functioning
Measured: Baseline and 1 year follow up
This is My Baby (TIMB)
A measure of the degree of committment to the child by the caregiver
Measured: Baseline and 1 year Follow up
The Development and Wellbeing Assessment (DAWBA)
A diagnostic intrument generating DSM and ICD psychiatric diagnoses.
Measured: Baseline and 1 year follow up for children over 2 years.
Cognitive assessment
This will be either the Bayley's or the WPPSI depending on the age of the child.
Measured: Baseline and 1 year follow up
The Use of Services Questionnaire
This carer-report questionnaire generates service use and costs data for health economic analysis
Measured: Baseline and 1 year follow up
The Strange Situation Procedure (SSP)
This is the gold standard measure for infant/toddler attachment patterns.
Measured: 1 year follow up only
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2011 (estimated)
- Study startDec 2011
- Primary completion28 Aug 2017
- Study completion28 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maltreated InfantsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 227 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Glasgow
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Helen Minnis, University of Glasgow
- Investigators
- Helen Minnis, MBChB, PhD, Principal investigator, University of GlasgowNiel Campbell, MBChB, PhD, Study chair, University of Aberdeen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01485510
- Sponsor's protocol ID
- CZH/4/629
- Acronym
- BEST?
- Status last verified
- Jun 2024
- First submitted
- 30 Nov 2011
- Last updated
- 4 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the New Orleans Intervention for Infant Mental Health in Glasgow
- ClinicalTrials.gov ID
- NCT01485510
- Acronym / sponsor ID
- BEST? / CZH/4/629
- Conditions
- Maltreated Infants
- Keywords
- Maltreatment, Infant Mental Health, Infant mental health in maltreated children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 227 participants (actual)
- Lead sponsor
- University of GlasgowUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- 28 Aug 2017 (actual)
- Study completion
- 28 Aug 2017 (actual)
- First posted
- 5 Dec 2011 (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.
Early intervention for maltreated infants can improve mental and physical health throughout life and benefit families and society as a whole. The New Orleans Model provides intensive assessment and treatment for families of maltreated preschool children in foster care, with recommendations to court about adoption, or permanent return to birth families. The New Orleans Model appears to have led to better informed decisions about permanent placement and to better child mental health in Louisiana. The investigators propose an exploratory randomised controlled trial investigating the effectiveness of the New Orleans Model in the Scottish context, informing the development of an economic model to explore the potential cost-effectiveness. Families with a maltreated child under 5 years of age will be offered the New Orleans Model or "case management" i.e. quality assured services as usual, using random allocation. The investigators will measure outcome using well validated measures of parent-child interaction, cognition and attachment.
Detailed description
The first 5 months of this trial - from December 2011 to April 2012 - is an internal pilot or "implementation period". During this time we have fewer research staff, both services will just have started and we will only be collecting selected outcome measures. These will be the Principle Outcome Measure, the Infant-Toddler Social-Emotional Assessment (ITSEA), plus the Disturbance of Attachment Interview (DAI) and Parent-Infant Global Assessment of Functioning (PIR-GAS). We hope to include data from implementation period in our trial analysis, but if results are very different due to services "bedding in", we may not do so
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glasgow Infant and Family Team (GIFT) | Experimental | Behavioral: GIFTA service developed by Charles Zeanah and colleagues in New Orleans, that aims to improve the mental health of maltreated infants. |
| Family Assessment & Contact Service | Active comparator | Behavioral: FACSA social-work based service that aims to assess maltreated children and make recommendations about their future care. |
Who may qualify
- Ages
- 6 to 60 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All maltreated children placed in foster care, aged between 6 and 60 months, whose parents give informed opt-in consent
Key exclusion criteria (1 listed)
- Children with profound learning disability
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 |
|---|---|---|
| GIFTAlso: New Orleans InterventionAn attachment-based assessment, then a tailored intervention aimed at maximising the chances of a maltreated child returning to the birth family. | Behavioural | Glasgow Infant and Family Team (GIFT) |
| FACSAlso: Case Management (Lieberman, 2005).A social work assessment of family functioning that makes recommendations regarding future placement of a maltreated child. | Behavioural | Family Assessment & Contact Service |
Primary outcome
Change in score on the Infant-Toddler Social-emotional Assessment (ITSEA)
Time frame: Baseline and at 1 year follow-up
The ITSEA is a well validated parent/carer-completed questionnaire covering a wide range of social and emotional behaviours in infants and preschool children. It has been shown to be sensitive to change in previous intervention research with maltreated children with medium to large effect sizes and has good longitudinal stability.
8 secondary outcomes
The Parent Evaluation of Development (PEDS)
Time frame: Baseline and 1 year follow up
The Disturbances of Attachment Interview (DAI)
Time frame: Baseline and 1 year follow up
The Parent-Infant Global Assessment of Functioning (PIR-GAS)
Time frame: Baseline and 1 year follow up
This is My Baby (TIMB)
Time frame: Baseline and 1 year Follow up
The Development and Wellbeing Assessment (DAWBA)
Time frame: Baseline and 1 year follow up for children over 2 years.
Cognitive assessment
Time frame: Baseline and 1 year follow up
The Use of Services Questionnaire
Time frame: Baseline and 1 year follow up
The Strange Situation Procedure (SSP)
Time frame: 1 year follow up only
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 4 Jun 2024.
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, MBChB, PhD principal investigator
University of Glasgow
Niel Campbell, MBChB, PhD study chair
University of Aberdeen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GIFT and FACS in people with Maltreated Infants, run by University of Glasgow at 1 site 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 4 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 1 site 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?
Change in score on the Infant-Toddler Social-emotional Assessment (ITSEA) (time frame: Baseline and at 1 year follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Jun 2024.