Clinical trial NCT04244721: Effectiveness of a Parent-mediated Intervention with PACT on Children with ASD
Official title: Effectiveness of PACT Intervention, Delivered by Parents, Guided by Videoconference, on the Autism of Their Children with ASD
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: interventions Early Start Denver Model (ESDM)
Preschool Autism Communication Therapy (PACT)
Lead sponsor: Hôpital le Vinatier
Sponsor class: OTHER
First posted: 2020-01-28
Enrollment: 212
Sex: ALL
Minimum age (years): 18
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: PARALLEL
Intervention model description: To make the comparison between the two groups on autism symptoms outcome measured with ADOS-2, with a power of 80% and an improvement of 0.6 points, we need 198 children (99 per group). After taking into account of a 20% consensual withdrawals and poor compliance with PACT, 238 children (119 per group) will be required. Each center will therefore have to include 50 children during the inclusion period.
Primary purpose: TREATMENT

Brief 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).

Eligibility criteria: 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)

Primary outcomes:
measure: Autism severity
timeFrame: 12 months
Secondary outcomes:
measure: Social Interactions of the child
timeFrame: 6 and 12 months
measure: Parent-child synchrony and initiative in communication
timeFrame: 6 and 12 months
measure: Number of words produced by the child
timeFrame: 12 months
measure: Number of words produced by the child
timeFrame: 12 months
measure: Adaptative behavior
timeFrame: 12 months
measure: Autism Family Experience
timeFrame: 12 months
measure: Characteristics of the parents
timeFrame: 12 months
measure: Characteristics of the parents
timeFrame: 12 months
Other outcomes:
Locations:
city: Bron
country: France
facility: Hopital Vinatier
Study officials:
References:
citation: Jurek L, Occelli P, Denis A, Amestoy A, Maffre T, Dauchez T, Oreve MJ, Baghdadli A, Schroder C, Jay A, Zelmar A, Revah-Levy A, Gallifet N, Aldred C, Garg S, Green J, Touzet S, Geoffray MM; IFPAD study group. Efficacy of parent-mediated communication-focused treatment in toddlers with autism (PACT) delivered via videoconferencing: a randomised controlled trial study protocol. BMJ Open. 2021 Apr 7;11(4):e044669. doi: 10.1136/bmjopen-2020-044669.