Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0012108171
Study information
Scientific title
Acronym
Study hypothesis
12 Children with autism (mean age 24 months) prospectively identified by use of a screening tool received a novel parent-training intervention for 18 months. A randomised control group received local services only, and a third (referred) group received an intensive ABA intervention. An interim follow-up conducted 12 months later revealed that the parent training group had made greater gains in language than the two other groups. We propose to look at outcome at age 5 years.
Added 19/10/09:
The final results were reported as an outcome study (see pubmed link below).
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Other
Trial setting
Other
Trial type
Treatment
Patient information sheet
Condition
Autism
Intervention
Randomised controlled trial. Random allocation to
1. Novel parent training
2. No training
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/09/2001
Overall trial end date
11/09/2003
Reason abandoned
Eligibility
Participant inclusion criteria
12 Children with autism (mean age 24 months) prospectively identified by use of a screening tool
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
12
Participant exclusion criteria
Does not match inclusion criteria
Recruitment start date
01/09/2001
Recruitment end date
11/09/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
c/o Research & Development Office
London
WC1N 1EH
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Great Ormond Street Hospital for Children NHS Trust / Institute of Child Health (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
2007 results in http://www.ncbi.nlm.nih.gov/pubmed/15845130
Publication citations
-
Results
Charman T, Taylor E, Drew A, Cockerill H, Brown JA, Baird G, Outcome at 7 years of children diagnosed with autism at age 2: predictive validity of assessments conducted at 2 and 3 years of age and pattern of symptom change over time., J Child Psychol Psychiatry, 2005, 46, 5, 500-513, doi: 10.1111/j.1469-7610.2004.00377.x.