Effectiveness of a Parent-mediated Intervention with PACT on Children with ASD (IFPAD)

Hôpital le Vinatier

Status: Enrolling

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 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).

Enrollment: 212 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 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
• Already receiving PACT therapy or any other intensive intervention (e.g. Denver)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Parallel Assignment

Masking: Single Blind

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212 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)