The evaluation of the cognitive behavioural treatment of pre-school children referred with hyperactivity

ISRCTN	ISRCTN05516741
DOI	https://doi.org/10.1186/ISRCTN05516741
Secondary identifying numbers	C/40/93/Sonuga; National Research Register ID: N0467011916

Submission date: 23/01/2004
Registration date: 23/01/2004
Last edited: 18/11/2009

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

Prof Edmund Sonuga-Barke
Scientific

University of Southampton
Dept of Psychology
Murray Building
Salisbury Road
Southampton
SO9 4NH
United Kingdom

Email	ejb3@soton.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title
Study objectives	To establish the efficacy of a health visitor administered treatment package for pre-school hyperactive children - assess the generalisability of treatment effects across therapists, situations and over time - examine its effects on parents moods and perceptions of their relationships with their children - test the relationship between parental perceptions, mood and child behaviour. The study will provide a systematic examination of the therapeutic value of a relatively inexpensive primary care intervention strategy which has the potential to reduce the long term social and economic costs associated with the generally poor prognosis of the hyperactive pre-school child. It will make available the sort of information that allows consultants and managers to make judgements about the potential of this sort of approach in their own areas of responsibility. It will provide the basis for the establishment of a centre of clinical excellence for the treatment of pre-school hyperactivity.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Attention-deficit hyperactivity disorder (ADHD)
Intervention	1. Parent training 2. Parent counselling and support 3. Waiting list (no treatment group)
Intervention type	Other
Primary outcome measure	Measures of child symptoms and mothers' well-being were taken before and after intervention and at 15 weeks follow-up.
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/10/1994
Completion date	28/09/1997

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	3 Years
Upper age limit	3 Years
Sex	Both
Target number of participants	Added 18/11/09: 78 children
Key inclusion criteria	Three-year-old children displaying a preschool equivalent of attention-deficit/hyperactivity disorder (ADHD)
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/10/1994
Date of final enrolment	28/09/1997

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

University of Southampton

Southampton
SO9 4NH
United Kingdom

Sponsor information

NHS R&D Regional Programme Register - Department of Health (UK)
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone	+44 (0)20 7307 2622
Email	dhmail@doh.gsi.org.uk
Website	http://www.doh.gov.uk

Funders

Funder type

Government

NHS Executive South West (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	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	01/04/2001		Yes	No