Condition category
Mental and Behavioural Disorders
Date applied
09/03/2016
Date assigned
10/03/2016
Last edited
31/10/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Autism is a lifelong condition that affects the way that a person communicates and relates to others. It is a spectrum condition, which means that the level of disability is spread across a wide range, from almost unnoticeable to completely debilitating. In general however, the difficulties sufferers experience tend to fall into social communication (speech and body language), social interaction (recognising and expressing emotions) and social imagination (being able to understand and predict other people’s behaviour). Children with autism often find it difficult to transfer skills learned in one setting to another. A previous study (the Preschool Autism Communication Trial, PACT) showed that in a clinical setting it was possible to help improve communication between parents and child however these improvements were less obvious in other settings. The aim of this study is to test ways to transfer the child’s communication gains into everyday home and education settings.

Who can participate?
Autistic children aged between 2 and 11 years.

What does the study involve?
This project is split into two phases. In the first phase, all participants receive the PACT-G therapy. This therapy involves coaching the parents in ways of interacting with their child. This takes place over a number of sessions, and is accompanied by sessions in educational settings (preschool or school) with educational staff. This part of the project is to find out whether schools are able take part and how easy it is to recruit participants for the study. In the second phase of the project, participants are randomly allocated to one of two groups. Those in the first group take part in the PACT-G therapy and those in the second group continue as usual, with no additional therapy. Children are assessed, and parents and teachers complete a number of questionnaires at the start, middle (7 months) and end (11 months) of the treatment.

What are the possible benefits and risks of participating?
Participants may benefit from improved communication abilities within different settings. There are no notable risks involved with taking part in this study.

Where is the study run from?
The study is run by University of Manchester and takes place in participants' homes and schools across Newcastle, Manchester and London (UK)

When is the study starting and how long is it expected to run for?
February 2016 to July 2019

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Dr Kathy Leadbitter

Trial website

http://www.pact-g.org/

Contact information

Type

Public

Primary contact

Dr Kathy Leadbitter

ORCID ID

Contact details

Room 3.316
Jean McFarlane Building
The University of Manchester
Oxford Road
Manchester
M13 9PT
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

20208

Study information

Scientific title

Paediatric Autism Communication Trial – Generalised (PACT-G)

Acronym

Study hypothesis

External pilot phase:
The aim of the external pilot phase is to:
1. Demonstrate schools’ willingness and ability to engage with the study
2. Demonstrate the ability to recruit and retain participants

Full randomised controlled trial:
The aim of this study is to test an intervention designed systematically to promote generalisation of previously demonstrated clinic-assessed treatment gains into home and school contexts.
Hypotheses:
1. The intervention will show the added efficacy and cost-effectiveness of preschool and school-age autism outcomes in home, school and research settings compared to treatment as usual
2. There will be an increase in the generalisation of acquired communication across contexts and persons, shown by mediation and the mechanistic study

Ethics approval

North West - Greater Manchester Central Research Ethics Committee, 28/01/2016, 15/NW/0912

Study design

External pilot phase: non-randomised feasibility study
Full randomised controlled trial: multi-centre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: Children, Mental Health; Subtopic: Children (all Diagnoses), Mental Health (Autism spectrum disorders); Disease: All Diseases, Autism spectrum disorders

Intervention

External pilot phase:
All participants receive the PACT-G therapy (see below)

Randomised controlled trial:
Participants are randomised to receive the PACT-G therapy (see below) or treatment as usual. Both groups will have a pre-randomisation baseline assessment, a mid-point (after approx 7 months) and end-point assessment (after approx 11 months).

Detail of the PACT-G intervention
PACT-G therapy is an enhancement of the original clinic-based PACT therapy. This is a ‘parent-mediated’ therapy in which caregivers are coached, using video-feedback, to interact with their child using evidence-based strategies that facilitate communication development in the child.

Parent sessions: Parents will receive 12 intervention sessions. Prior to starting the intervention, a home visit is conducted to introduce the intervention to the parents, explore the family context and set expectations. Where feasible the first two sessions are delivered in a clinic, allowing the parent to learn early strategies in a controlled environment with a set of toys specially selected to facilitate interaction. Subsequent sessions are a mix of home based sessions and Skype/telephone-delivered consultation. Each parent session begins with a discussion of progress made since the last session. The parent and therapist then watch a 5-minute video, either a video made by the therapist of the parent and child in play or a parent-made video of a home based routine, such as mealtime. The therapist facilitates the parent to identify actions that lead to child communication and to adopt PACT-G strategies in their interaction with the child. Parents are assisted to set goals for themselves, based on the interaction strategies discussed. They are asked to practice these daily, initially in a half hour ‘special time’, but eventually during naturalistic opportunities throughout the day.

Education setting sessions: Therapy in the educational setting begins 1 - 2 months after the parent has commenced therapy, with a start time integrating into the school term schedule. In the education setting PACT-G sessions will be delivered to trained learning support assistants (LSA), who are additional staff with a specific remit to attend to the child’s special needs and thus with dedicated individual time in the classroom or nursery. LSAs and other education staff receive an initial training session to introduce them to PACT-G therapy. The education-based intervention then consists of therapist-LSA sessions that mirror the therapist-parent sessions in the home. Videos are made of the LSA and the child and are used to coach the LSA in the use of appropriate PACT-G strategies. The LSA then implements these with the child daily in class time. There are 12 therapist-LSA sessions over 6 months, alternating in-school visits and skype/telephone consultation. PACT-G strategies will also be integrated in a complementary way with other communication strategies that may already be in use in the school.

Collaboration between parent and educational staff: Importantly, the separate therapeutic work with parents and LSAs described above will be supplemented with a schedule of joint parent-LSA meetings to support the work and ensure consistent use of strategies across home and education settings. The meetings will use the manualised technique of ‘Structured Conversation with Parents’ (SCP). Meetings are structured around ‘explore’, ‘focus’, ‘plan’ and ‘review’ stages, which allow the LSA and parent to share experiences and maximize intervention consistency.

Intervention type

Other

Phase

Drug names

Primary outcome measures

External pilot phase:
1. School engagement rate is determined by the total number of schools which have signed up to participate at the end of pilot phase, i.e. 6 months
2. Family recruitment rate is determined by the total number of families which have consented up to participate at the end of pilot phase, i.e. 6 months

Main randomised controlled trial:
Efficacy of the PACT-G therapy, which is assessed at mid-point (approx 6 - 8 months) and end-point (approx 11 months), with exact assessment tools to be determined during the external pilot phase.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/02/2016

Overall trial end date

30/07/2019

Reason abandoned

Eligibility

Participant inclusion criteria

Current inclusion criteria as of 18/10/2017:
1. Child over 2 years 0 months and under 11 years 0 months
2. Child has confirmed diagnosis of autism spectrum disorder
3. Child meets criteria for core autism on the Autism Diagnostic Observation Schedule (ADOS-2) and the Social Communication Questionnaire
4. Children who are aged 5 years and over are between P3 and P8 for the English curriculum
5. Parent has spoken English which is adequate to participate in this communication based intervention and speaks English to their child at least some of the time

Previous inclusion criteria:
1. Child between 2 and 11 years (in primary school) with a diagnosis of autism
2. Family will have spoken English at home which is adequate to allow them potentially to participate in this communication based intervention

­Pre-school cohort:
1. Aged 2 years to 4 years 11 months
2. Meeting criteria for core autism on 2 from 3 modules of Autism Diagnostic Observation Schedule (ADOS­2) the Autism Diagnostic Interview ­Revised (ADI­R)
3. Parents using spoken English at home
4. Above 12 months equivalent level in general (non language) development.

­School age cohort:
1. Aged 5 to 11 years
2. In primary school for length of participation in study
3. Meeting criteria for ASD on the Autism Diagnostic Observation Schedule (ADOS­2) and Social Communication Questionnaire (SCQ)
4. Developmentally from the beginning of intentional language to the beginning of fluent speech

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

Planned Sample Size: 24 in External pilot phase and 244 in main RCT; UK Sample Size: 24 and 244

Participant exclusion criteria

Current exclusion criteria as of 18/10/2017:
1. Having a sibling with ASD already in the trial
2. Participation in PACT pilot phase
3. Child has <= 12 months nonverbal age equivalent
4. Long-term severe hearing or visual impairment in child or parent
5. Epilepsy that is uncontrolled by medication
6. Severe learning disability in the parent or current clinically severe psychiatric illness in parent
7. Current safeguarding concerns or other family situation that would affect child / family participation in the trial
8. No agreement to participate from child’s education setting

Previous exclusion criteria:
1. Having a sibling with autism already in the trial
2. Only one child with autism per family can be included
3. Seizures uncontrolled by medication
4. Neither child or parent will have long term severe hearing or visual impairment that would limit participation in the intervention
5. Current clinically severe psychiatric illness in parents

Recruitment start date

01/07/2016

Recruitment end date

31/03/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Manchester
Room 3.316, Jean McFarlane Building Oxford Road
Manchester
M13 9PT
United Kingdom

Sponsor information

Organisation

Central Manchester & Manchester Children's University Hospitals NHS Trust & University of Manchester

Sponsor details

5th Floor (Research)
St Mary's Hospital
Oxford Road
Manchester
M13 9WL
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

The study protocol is currently available at http://www.pact-g.org. The trialists are planning to submit the protocol and analysis plan for publication within the next few months. Planned publication of the study results in a high-impact peer reviewed journal in 2020.

IPD sharing statement:
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

30/07/2020

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

31/10/2017: Internal review. 18/10/2017: The following changes were made to the trial record: 1. The recruitment end date was changed from 31/12/2016 to 31/03/2018. 2. Publication and dissemination plan added. 18/03/2016: The recruitment start and end date provided refers only to the external pilot phase of the study. The recruitment dates for the main randomised controlled trial are 01/01/2017 - 31/05/2018 (treatment and assessments run to 31/01/2019).