The evaluation of the cognitive behavioural treatment of pre-school children referred with hyperactivity
| ISRCTN | ISRCTN05516741 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN05516741 |
| Protocol serial number | C/40/93/Sonuga; National Research Register ID: N0467011916 |
| Sponsor | NHS R&D Regional Programme Register - Department of Health (UK) |
| Funder | NHS Executive South West (UK) |
- 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
Scientific
University of Southampton
Dept of Psychology
Murray Building
Salisbury Road
Southampton
SO9 4NH
United Kingdom
| ejb3@soton.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Measures of child symptoms and mothers' well-being were taken before and after intervention and at 15 weeks follow-up. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 28/09/1997 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 3 Years |
| Upper age limit | 3 Years |
| Sex | All |
| Target sample size at registration | 78 |
| 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
- United Kingdom
- England
Study participating centre
University of Southampton
Southampton
SO9 4NH
United Kingdom
SO9 4NH
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 | 01/04/2001 | Yes | No |
