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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

212 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-30

Study Completion Date

2026-08-31

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Autism Spectrum Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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a group of children receiving the usual therapy (TAU)

Children will receive therapies available in the community as speech language therapist or occupational therapist.

Group Type SHAM_COMPARATOR

Treatment As Usual (TAU)

Intervention Type OTHER

Children will receive therapies available in the community as speech language therapist or occupational therapist.

a group of children receiving TAU plus the PACT intervention.

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.

Group Type EXPERIMENTAL

Preschool Autism Communication Therapy (PACT)

Intervention Type OTHER

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.

Interventions

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Preschool Autism Communication Therapy (PACT)

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.

Intervention Type OTHER

Treatment As Usual (TAU)

Children will receive therapies available in the community as speech language therapist or occupational therapist.

Intervention Type OTHER

Eligibility Criteria

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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)

Minimum Eligible Age

18 Months

Maximum Eligible Age

36 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No