Condition category
Mental and Behavioural Disorders
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
18/11/2009
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 Edmund Sonuga-Barke

ORCID ID

Contact details

University of Southampton
Dept of Psychology
Murray Building
Salisbury Road
Southampton
SO9 4NH
United Kingdom
ejb3@soton.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

C/40/93/Sonuga; National Research Register ID: N0467011916

Study information

Scientific title

Acronym

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Attention-deficit hyperactivity disorder (ADHD)

Intervention

1. Parent training
2. Parent counselling and support
3. Waiting list (no treatment group)

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/10/1994

Overall trial end date

28/09/1997

Reason abandoned

Eligibility

Participant inclusion criteria

Three-year-old children displaying a preschool equivalent of attention-deficit/hyperactivity disorder (ADHD)

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

Added 18/11/09: 78 children

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/10/1994

Recruitment end date

28/09/1997

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Southampton
Southampton
SO9 4NH
United Kingdom

Sponsor information

Organisation

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

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Executive South West (UK)

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

2001 results in http://www.ncbi.nlm.nih.gov/pubmed/11314565

Publication citations

  1. Results

    Sonuga-Barke EJ, Daley D, Thompson M, Laver-Bradbury C, Weeks A, Parent-based therapies for preschool attention-deficit/hyperactivity disorder: a randomized, controlled trial with a community sample., J Am Acad Child Adolesc Psychiatry, 2001, 40, 4, 402-408, doi: 10.1097/00004583-200104000-00008.

Additional files

Editorial Notes