Early intervention for at-risk children: three-year follow up

ISRCTN	ISRCTN63835525
DOI	https://doi.org/10.1186/ISRCTN63835525
Protocol serial number	N/A
Sponsor	Northern and Yorkshire Research and Development Directorate (UK)
Funder	Northern and Yorkshire Research and Development Directorate (UK)

Submission date: 28/06/2008
Registration date: 29/08/2008
Last edited: 08/08/2011

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

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Paul McArdle
Scientific

Fleming Nuffield Unit
Burdon Terrace
Newcastle upon Tyne
NE3 4EX
United Kingdom

Phone	+44 (0)7775 925 838
Email	mcardlep@btinternet.com

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	School-based indicated prevention: two and three year follow up of a randomised trial of group therapy
Study objectives	The hypothesis was that drama group intervention would reduce symptoms of mental disorder among children teacher-identified children meeting a number of criteria. These were: 1. Scholastic under-performance 2. Known major family problems 3. Ill-nourished or poorly cared for appearance 4. Impaired peer relationships 5. Behavioural or emotional difficulties
Ethics approval(s)	Ethics approval received from the Newcastle upon Tyne Ethics Committee in 1995.
Health condition(s) or problem(s) studied	Mental disorder in children and young people
Intervention	Interventions comprised drama group therapy (DGT), comprising reflective discussion and role play conducted by a drama therapy trained teacher. The role play was central to the drama therapy and involved mini-plays using themes suggested by the children themselves such as disciplinary episodes involving teachers or police, family difficulties and peer issues, seeking for alternative practicable routes to more satisfactory solutions from the participants' perspectives. The control curriculum studies (CS) comparison involved teaching mathematics and English also delivered in the children's school. The CS group was encouraged in the formation of a positive peer group that focused on developing skills in mathematics and English. During the sessions no attempt was made to investigate any emotional/behavioural issues, but the pedagogy was strongly inclusive and supportive, with clear expectations for conduct. The group leader used focused praise for achievement of task outcome and collaborative behaviours shown by the group. The two groups each ran for an hour a week over a 12 week period and were conducted during school hours. The follow up took place over three years. Please note that the sponsor and funder of this trial, Northern and Yorkshire Research and Development Directorate (UK), does not exist any more due to restructuring in the NHS.
Intervention type	Other
Primary outcome measure(s)	Scores on behaviour parent- teacher- and self-report mental health questionnaires: 1. The Child Behaviour Checklist 2. Teacher Report Form 3. Youth Self Report Data were gathered three months pre-intervention and at the start of intervention (waiting list control), at the end of intervention (+three months), six months, one year, two years and three years post-intervention.
Key secondary outcome measure(s)	No secondary outcome measures.
Completion date	15/04/2001

Eligibility

Participant type(s)	Patient
Age group	Child
Sex	All
Target sample size at registration	122
Key inclusion criteria	1. Children of either sex 2. Scholastic under-performance 3. Known major family problems 4. Ill-nourished or poorly cared for appearance 5. Impaired peer relationships 6. Behavioural or emotional difficulties
Key exclusion criteria	Not at school.
Date of first enrolment	15/09/1996
Date of final enrolment	15/04/2001

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Fleming Nuffield Unit

Newcastle upon Tyne
NE3 4EX
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/09/2002		Yes	No