Effectiveness of PACT Intervention, Delivered by Parents, Guided by Videoconference, on the Autism of Their Children With ASD
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Autism Spectrum Disorder
- Sponsor
- Hôpital le Vinatier
- Enrollment
- 212
- Locations
- 1
- Primary Endpoint
- Autism severity
- Status
- Recruiting
- Last Updated
- 9 months ago
Overview
Brief Summary
Autism Spectrum Disorder (ASD) is a neuro-developmental disorders. There are different types of interventions. Among these interventions Early Start Denver Model (ESDM) and Preschool Autism Communication Therapy (PACT) have proved efficacy at short and long term. PACT is the therapy with the highest evidences when Parents delivered the intervention themselves.
Detailed Description
In PACT, parents are guided, generally in face to face, by a professional to improve the synchrony and communication with their children with ASD. Then, it is recommended to the parents to practice the therapy daily at home. In France, this type of early intervention is poorly developed and is only accessible in specialized centers located in large urban centers. Guiding parents by videoconferencing could make this intervention accessible to families in undeserved areas. The objective of this study is to evaluate the effectiveness of a PACT intervention delivered by parents and guided by videoconferencing, on the autism in their children with ASD, aged 18 to 36 months at the inclusion. This is a mixed (quantitative and qualitative), multicenter, controlled, randomized, open-label study, comparing a group of children receiving usual care and one of whose parents is trained and accompanied by videoconferencing to developmental techniques as described in the PACT, to a group of children benefiting only from the usual care provided by the community. The primary endpoint was the severity of autism measured with the ADOS-2 (2012 Autism Diagnostic Observation Schedule) severity score (CSS) at 12 months. A total of 212 children will be included in the study (106 / group).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Child with autism Spectrum disorder
- •Symptoms in autism with a severity superior to 4 as measure by ADOS-2
- •Positive ADI (Autism Diagnostic Interview)
- •Diagnostic done by a multidisciplinary team
- •Nonverbal IQ above 12 months Having health assurance
Exclusion Criteria
- •For the child
- •Child with a twin brother or sister with ASD or having a brother or sister already included in this study
- •Epilepsy requiring medication
- •Severe hearing or visual impairment
- •Identification of a genetic anomaly causes participation in the intervention or validity of the data (determined by the principal investigator on a case-by-case basis)
- •For the parents
- •Severe hearing or visual impairment
- •Severe psychiatric disorder
- •Unstable somatic disorders preventing intervention
- •Lack of Internet access
Outcomes
Primary Outcomes
Autism severity
Time Frame: 12 months
Change between baseline and 12 months in the overall raw score at ADOS-2 (Autism Diagnostic Observation Schedule version 2), Module 1
Secondary Outcomes
- Social Interactions of the child(6 and 12 months)
- Parent-child synchrony and initiative in communication(6 and 12 months)
- Number of words produced by the child(12 months)
- Adaptative behavior(12 months)
- Autism Family Experience(12 months)
- Characteristics of the parents(12 months)