Condition category
Mental and Behavioural Disorders
Date applied
31/07/2014
Date assigned
31/07/2014
Last edited
07/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 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

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

Sponsor information

Organisation

University of Manchester (UK)

Sponsor details

Oxford Road
Manchester
M13 9PL
United Kingdom

Sponsor type

University/education

Website

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

Publication citations

Additional files

Editorial Notes

07/03/2016: Verifying study status with principal investigator.