Preschool Autism Communication Trial

ISRCTN	ISRCTN58133827
DOI	https://doi.org/10.1186/ISRCTN58133827
Secondary identifying numbers	G0401546

Submission date: 20/02/2006
Registration date: 03/04/2006
Last edited: 31/10/2016

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

Study website

Contact information

Prof Jonathan Green
Scientific

Academic Department of Child and Adolescent Psychiatry
Booth Hall Children's Hospital
University of Manchester
Manchester
M9 7AA
United Kingdom

Phone	+44 161 306 7941
Email	jonathan.green@manchester.ac.uk

Study information

Study design	Three-site two-arm single (rater) blinded randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Participant information sheet	Study information for participants in http://www.medicine.manchester.ac.uk/pact/participants/
Scientific title	Preschool Autism Communication Trial
Study acronym	PACT
Study objectives	The main hypothesis is that the addition of a systematic, theory-based preschool family intervention, targeted on known core social communication impairments in autism, will result in significant improvement in autism-specific symptoms compared to Treatment As Usual (TAU). Secondary hypotheses are that: 1. This improvement will be mediated by changes in specific aspects of parent-child communication targeted by the treatment 2. General language development will be accelerated 3. Teacher-observed child adaptation will be improved
Ethics approval(s)	Central Manchester Research Ethics Committee, 09/03/2006, ref: 05/Q1407/311
Health condition(s) or problem(s) studied	Autism
Intervention	Treatment versus treatment as usual, evaluated on standard autism and behavioural instruments and including health economic analysis. Trial treatment: the PACT intervention targets core social interactive and language/communication impairments in autism, which have been identified in developmental research. The treatment is manualised and staged to reflect the developmental progression of pre-linguistic skills and video feedback is used throughout the treatment. Following the 6-month primary intervention, there is a second 6-month period in which there are monthly booster sessions. These focus on the consolidation and generalisation of treatment gains into everyday routines. TAU: families in both arms of the trial will continue with TAU provided by their services. All aspects of TAU will be measured as part of the economic data collection, which will allow us to evaluate its nature and intensity.
Intervention type	Other
Primary outcome measure	Primary outcome measures amended as of 01/08/2007: Endpoint is 13 months after start of treatment. The primary outcome will be the total score on the ADOS-G, a structured play-based assessment between researcher and child, videotaped for independent coding within domains of reciprocal social interaction, language, communication and autism specific behaviours. It will be rated blind to case status. The ADOS-G is the gold standard observational measure of autism specific symptoms. There will also be economic analysis including cost effectiveness. Primary outcome measures provided at time of registration: Endpoint is 12 months after start of treatment. The primary outcome will be the total score on the ADOS-G, a structured play-based assessment between researcher and child, videotaped for independent coding within domains of reciprocal social interaction, language, communication and autism specific behaviours. It will be rated blind to case status. The ADOS-G is the gold standard observational measure of autism specific symptoms. There will also be economic analysis including cost effectiveness.
Secondary outcome measures	Added as of 31/07/2007: Parent-Child Interaction measure (PCI): MacArthur Communication Development Inventory (MCDI), Preschool Language Scales (PLS) and the Teacher Vineland Adaptive Behaviour Schedule (TVABS)
Overall study start date	13/02/2006
Completion date	12/10/2009

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	2 Years
Upper age limit	4 Years
Sex	Both
Target number of participants	144; 72 in each treatment arm
Key inclusion criteria	Children between the ages of 2 and 4 years 11 months, fulfilling diagnostic criteria for core autistic disorder on both social and communication domains of the Autism Diagnostic Observation Schedule-Generic (ADOS-G) - the primary outcome measure, and on two out of the three functional domains of the Autism Diagnostic Interview-Revised (ADI-R).
Key exclusion criteria	1. Cases where primary language at home is not English 2. Significant hearing or visual impairment in child or adult 3. Clinically severe psychiatric illness in parents We judge that the above features could make a treatment based on dyadic communication unreliable to administer. 4. Children below a threshold of 11-month non-verbal developmental age assessed on the Mullen scales of early learning will also be excluded Additional exclusion criteria added as of 01/08/2007: 5. Twins 6. Epilepsy requiring regular medication
Date of first enrolment	13/02/2006
Date of final enrolment	12/10/2009

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Booth Hall Children's Hospital

Manchester
M9 7AA
United Kingdom

Sponsor information

University of Manchester (UK)
University/education

University of Manchester
Manchester
M9 7AA
England
United Kingdom

Website	http://www.manchester.ac.uk/
"ROR"	https://ror.org/027m9bs27

Funders

Funder type

Government

Medical Research Council (MRC) (UK)
Government organisation / National government

Alternative name(s): Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location: United Kingdom

Department for Education and Skills (DFES) (UK)

No information available

Department of Health (DoH) (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Results article	results	19/06/2010	Yes	No
Results article	results	21/12/2015	Yes	No
Results article	long-term follow-up results	19/11/2016	Yes	No

Editorial Notes

31/10/2016: Publication reference added.
23/12/2015: Publication reference added.