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 designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study objectivesTo 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) studiedAttention-deficit hyperactivity disorder (ADHD)
Intervention1. Parent training
2. Parent counselling and support
3. Waiting list (no treatment group)
Intervention typeOther
Primary outcome measureMeasures of child symptoms and mothers' well-being were taken before and after intervention and at 15 weeks follow-up.
Secondary outcome measuresNot provided at time of registration
Overall study start date01/10/1994
Completion date28/09/1997

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit3 Years
Upper age limit3 Years
SexBoth
Target number of participantsAdded 18/11/09: 78 children
Key inclusion criteriaThree-year-old children displaying a preschool equivalent of attention-deficit/hyperactivity disorder (ADHD)
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/10/1994
Date of final enrolment28/09/1997

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 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?
Results article results 01/04/2001 Yes No