Contact information
Type
Scientific
Primary contact
Prof Jonathan Hill
ORCID ID
Contact details
HCD
School of Psychological Sciences
Humanities
Devas Street
Oxford Road
Manchester
M13 9PL
United Kingdom
+44 161 275 0723
Jonathan.Hill@manchester.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
16637
Study information
Scientific title
Pilot evaluation of a brief family domains intervention for parents of children referred with emotional and behavioural problems: The Manchester parent-child preparation study
Acronym
Study hypothesis
Mental health problems in children commonly persist or recur. Effective treatment is therefore crucial. Parent training is effective however it is demanding on parents time, and drop outs are common. We therefore propose to evaluate a brief, one session, intervention offered to parents in groups, between the time of referral and first appointment. This takes as its starting point that children with mental health problems have difficulties with emotions such as anxiety, sadness or anger, or problems in controlling behaviours. This presents a challenge to parents as to how to attend to their childrens emotional needs, and provide discipline, while preserving pleasurable times together. In the groups, these different activities of children with parents, known as domains, are explained and discussed. The aim is to provide parents with tools to evaluate their childrens behaviours, and to make choices about how they respond to promote emotional and behavioural regulation.
Ethics approval
North West - Greater Manchester West Research Ethics Committee, 28/01/2014, ref: 13/NW/0870
Study design
Randomised; Interventional; Design type: Treatment
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Topic: Children, Mental Health; Subtopic: All Diagnoses, Anxiety; Disease: Anxiety, All Diseases
Intervention
Following provision of informed consent, parents will be randomized in the ratio 2:1 (120 intervention) no more than 4 weeks prior to their first clinical appointment. Parents will either be invited to a group meeting to receive the domains-based parent training or will wait for their first appointment in the usual way.
Child adjustment and parental criticism of the child will be measured before and after the group in the intervention arm (and at two equivalent points in the control group), and after 3 months. Parents experience of the groups will be assessed and usage of NHS resources will be measured.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Parental criticism is assessed using the 5 minute speech sample at baseline, 4 and 12 weeks
Secondary outcome measures
1. Child behaviour checklist at baseline, 4 and 12 weeks
2. Strengths and difficulties questionnaire at baseline, 4 and 12 weeks
Overall trial start date
02/06/2014
Overall trial end date
31/05/2016
Reason abandoned
Eligibility
Participant inclusion criteria
Parents of children up to the age of 11 years referred to an innercity Child and Adolescent Mental Health Service (CAMHS)
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
Planned Sample Size: 180; UK Sample Size: 180
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
02/06/2014
Recruitment end date
31/05/2016
Locations
Countries of recruitment
United Kingdom
Trial participating centre
HCD
Manchester
M13 9PL
United Kingdom
Funders
Funder type
Government
Funder name
NIHR Research for Patient Benefit (RfPB); Grant Codes: PB-PG-0610-22260
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary