Condition category
Mental and Behavioural Disorders
Date applied
20/02/2006
Date assigned
03/04/2006
Last edited
31/10/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.medicine.manchester.ac.uk/pact/

Contact information

Type

Scientific

Primary contact

Prof Jonathan Green

ORCID ID

Contact details

Academic Department of Child and Adolescent Psychiatry
Booth Hall Children's Hospital
University of Manchester
Manchester
M9 7AA
United Kingdom
+44 161 306 7941
jonathan.green@manchester.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

G0401546

Study information

Scientific title

Preschool Autism Communication Trial

Acronym

PACT

Study hypothesis

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

Central Manchester Research Ethics Committee, 09/03/2006, ref: 05/Q1407/311

Study design

Three-site two-arm single (rater) blinded randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Study information for participants in http://www.medicine.manchester.ac.uk/pact/participants/

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

13/02/2006

Overall trial end date

12/10/2009

Reason abandoned

Eligibility

Participant 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).

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

144; 72 in each treatment arm

Participant 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

Recruitment start date

13/02/2006

Recruitment end date

12/10/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Booth Hall Children's Hospital
Manchester
M9 7AA
United Kingdom

Sponsor information

Organisation

University of Manchester (UK)

Sponsor details

University of Manchester
Manchester
M9 7AA
United Kingdom

Sponsor type

University/education

Website

http://www.manchester.ac.uk/

Funders

Funder type

Government

Funder name

Medical Research Council (MRC) (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Funder name

Department for Education and Skills (DFES) (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Department of Health (DoH) (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

2010 results in: http://www.ncbi.nlm.nih.gov/pubmed/20494434
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26691535
2016 long-term follow-up results in: http://www.ncbi.nlm.nih.gov/pubmed/27793431

Publication citations

  1. Results

    Green J, Charman T, McConachie H, Aldred C, Slonims V, Howlin P, Le Couteur A, Leadbitter K, Hudry K, Byford S, Barrett B, Temple K, Macdonald W, Pickles A, , Parent-mediated communication-focused treatment in children with autism (PACT): a randomised controlled trial., Lancet, 2010, 375, 9732, 2152-2160, doi: 10.1016/S0140-6736(10)60587-9.

Additional files

Editorial Notes

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