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
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
-
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.