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

H

Hôpital le Vinatier

Status

Unknown

Conditions

Autism Spectrum Disorder

Treatments

Other: Treatment As Usual (TAU)
Other: Preschool Autism Communication Therapy (PACT)

Study type

Interventional

Funder types

Other

Identifiers

NCT04244721
2018-A02516-49

Details and patient eligibility

About

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.

Full 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).

Enrollment

238 estimated patients

Sex

All

Ages

18 to 36 months old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

238 participants in 2 patient groups

a group of children receiving the usual therapy (TAU)
Sham Comparator group
Description:
Children will receive therapies available in the community as speech language therapist or occupational therapist.
Treatment:
Other: Treatment As Usual (TAU)
a group of children receiving TAU plus the PACT intervention.
Experimental group
Description:
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.
Treatment:
Other: Preschool Autism Communication Therapy (PACT)

Trial contacts and locations

1

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Central trial contact

Lydie SARTELET

Data sourced from clinicaltrials.gov

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