Hearts and minds
Research type
Research Study
Full title
A pilot study of the follow-up of 7-10 year old children previously randomised to the Best Services Trial (BeST?) to eventually (in a separate larger study) assess why some maltreated children develop mental (and physical) health problems and others do not.
IRAS ID
200032
Contact name
Helen Minnis
Contact email
Sponsor organisation
NHS Greater Glasgow & Clyde
Clinicaltrials.gov Identifier
NCT02653716, Clinicial Trials.gov identifier for BeST Services Trial
Duration of Study in the UK
0 years, 11 months, 28 days
Research summary
Children who have experienced abuse or neglect are at increased risk of mental and physical health problems throughout life, placing a burden on families and society. This study is a feasibility study in which children aged 7-10 years who have already participated in the BeST? Services Trial (an ongoing randomized controlled trial examining an infant mental health intervention for children coming into an episode of care for maltreatment in Glasgow) will be recruited. We will attempt to consent these children for interventions designed to understand which children are at risk of mental and physical problems throughout their lives. The tests include:
Stress hormones (through a hair sample)
Stress responsivity (through testing autonomic functioning via an established protocol)
Pain threshold (through an established protocol linked to the autonomic responsivity protocol)
Emotional dysregulation (through questionnaires/observations)
Facial emotion recognition (through observation)
Immune functioning (through blood samples)
Epigenetics (through blood samples)
Microbiome (through cheek swabs)
These tests will be performed across a maximum of two separate research visits to the West Glasgow Ambulatory Care Hospital and the Queen Elizabeth University Hospital.
MRI Scanning - to investigate the Salience Network. This will be conducted at the Queen Elizabeth University Hospital.
Approximately 20 eligible families will be recruited from those already consented to participate in the BeST? Services Trial. 20 comparison children, matched on age and gender, will be recruited from the general population "Ready to Learn" cohort. This feasibility study will be used to establish whether it is possible to consent children to a future larger study involving the above measures, and to inform the sample size required for that future larger study.
We also have obtained funding from the CSO catalyst grant) to conduct qualitative interviews and focus groups with children and their parents to ensure that assessments are acceptable and to suggest any modifications needed. This will be subject to a future application.REC name
West of Scotland REC 5
REC reference
18/WS/0069
Date of REC Opinion
7 Sep 2018
REC opinion
Further Information Favourable Opinion