Effectiveness of a Parent-mediated Intervention With PACT on Children With ASD
-
- STATUS
- Recruiting
-
- participants needed
- 238
-
- sponsor
- Hôpital le Vinatier
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.
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 study is a multicenter (5 centers), two-parallel-group, randomised controlled trial. It will compare a group of children receiving the usual therapy (TAU) and a group receiving TAU plus the PACT intervention. The primary outcome is the autism symptoms measured with the ADOS-2 (Autism Diagnostic Observation Schedule) at 12 months. A total of 238 children will be included in the study (119 per group).
Details
| Condition | Pervasive developmental disorder |
|---|---|
| Age | 1years - 1years |
| Treatment | Treatment as usual (TAU), Preschool Autism Communication Therapy (PACT) |
| Clinical Study Identifier | NCT04244721 |
| Sponsor | Hôpital le Vinatier |
| Last Modified on | 19 February 2024 |
How to participate?
Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
Learn moreSimilar trials to consider
Browse trials for
Not finding what you're looking for?
Sign up as a volunteer to stay informed
Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.
Sign up as volunteerStudy Definition
WikipediaAdd a private note
- Select a piece of text.
- Add notes visible only to you.
- Send it to people through a passcode protected link.