ISRCTN ISRCTN20501647
DOI https://doi.org/10.1186/ISRCTN20501647
Secondary identifying numbers 16637
Submission date
31/07/2014
Registration date
31/07/2014
Last edited
06/06/2018
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Jonathan Hill
Scientific

HCD
School of Psychological Sciences
Humanities
Devas Street, Oxford Road
Manchester
M13 9PL
United Kingdom

Phone +44 161 275 0723
Email Jonathan.Hill@manchester.ac.uk

Study information

Study designRandomised; Interventional; Design type: Treatment
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titlePilot evaluation of a brief family domains intervention for parents of children referred with emotional and behavioural problems: the Manchester parent-child preparation study
Study objectivesMental 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 children’s 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 children’s behaviours, and to make choices about how they respond to promote emotional and behavioural regulation.
Ethics approval(s)North West - Greater Manchester West Research Ethics Committee, 28/01/2014, ref: 13/NW/0870
Health condition(s) or problem(s) studiedTopic: Children, Mental Health; Subtopic: All Diagnoses, Anxiety; Disease: Anxiety, All Diseases
InterventionFollowing 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 typeOther
Primary outcome measureParental criticism is assessed using the 5 minute speech sample at baseline, 4 and 12 weeks
Secondary outcome measures1. Child behaviour checklist at baseline, 4 and 12 weeks
2. Strengths and difficulties questionnaire at baseline, 4 and 12 weeks
Overall study start date02/06/2014
Completion date31/05/2016

Eligibility

Participant type(s)Patient
Age groupChild
Upper age limit11 Years
SexBoth
Target number of participantsPlanned Sample Size: 180; UK Sample Size: 180
Key inclusion criteriaParents of children up to the age of 11 years referred to an innercity Child and Adolescent Mental Health Service (CAMHS)
Key exclusion criteriaNot provided at time of registration
Date of first enrolment02/06/2014
Date of final enrolment31/05/2016

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

HCD
Manchester
M13 9PL
United Kingdom

Sponsor information

University of Manchester (UK)
University/education

Oxford Road
Manchester
M13 9PL
England
United Kingdom

ROR logo "ROR" https://ror.org/027m9bs27

Funders

Funder type

Government

NIHR Research for Patient Benefit (RfPB); Grant Codes: PB-PG-0610-22260

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
HRA research summary 28/06/2023 No No

Editorial Notes

06/06/2018: No publications found, verifying study status with principal investigator.
07/03/2016: Verifying study status with principal investigator.