Topic: Children, Mental Health
Conditions
Interventions
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.
Sponsors
Central Manchester & Manchester Children's University Hospitals NHS Trust & University of Manchester
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Not provided at time of registration | — |
Countries
England, United Kingdom
Contacts
Public ContactKathy Leadbitter
Outcome results
None listed