NCT04244721

Effectiveness of a Parent-mediated Intervention With PACT on Children With ASD

Effectiveness of PACT Intervention, Delivered by Parents, Guided by Videoconference, on the Autism of Their Children With ASD

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 212 (estimated)
• Sponsor: Hôpital le Vinatier · Academic / Other
• Sex: All
• Age: 18 Months – 36 Months
• Healthy volunteers: Not accepted

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).

Conditions

• Autism Spectrum Disorder

Interventions

Type	Name	Description
OTHER	Preschool Autism Communication Therapy (PACT)	Professionals guide parents in the PACT therapy by videoconference. Sessions between parent and professionals are every 15 days for 6 months. Each session lasts one hour. At the end of the 12 sessions, additional booster sessions (one session per month over 6 months) will allow parents to maintain their skills. Parents will use therapy with their children in daily home practice. The aims of PACT therapy is to improve synchrony in the communication between the child and the parents. Improvement of the synchrony will mediate the decrease of autism symptoms of the child.
OTHER	Treatment As Usual (TAU)	Children will receive therapies available in the community as speech language therapist or occupational therapist.

Timeline

• Start date: 2020-06-30
• Primary completion: 2026-06-01
• Completion: 2026-08-01
• First posted: 2020-01-28
• Last updated: 2025-07-28

Locations

1 site across 1 country: France