Condition category
Mental and Behavioural Disorders
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
19/10/2009
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

Dr T Charman

ORCID ID

Contact details

c/o Research & Development Office
Institute of Child Health
30 Guilford Street
London
WC1N 1EH
United Kingdom

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

http://www.doh.gov.uk

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

  1. 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.

Additional files

Editorial Notes