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

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

Recruiting
18-36 years
All
Phase N/A

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Overview

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).

Eligibility

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 Live more than 40 min from a Center for resources in autism -Parents speaking French 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
  • Parent not available for regular follow-up
  • Opposition of one parent to the child's participation in a study

Study details
    Autism Spectrum Disorder

NCT04244721

Hôpital le Vinatier

26 January 2024

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