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

  • STATUS
    Recruiting
  • participants needed
    238
  • sponsor
    Hôpital le Vinatier
Updated on 19 February 2024
autism
pervasive developmental disorder
developmental disabilities
developmental disorder

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.

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).

Details
Condition Pervasive developmental disorder
Age 1years - 1years
Treatment Treatment as usual (TAU), Preschool Autism Communication Therapy (PACT)
Clinical Study IdentifierNCT04244721
SponsorHôpital le Vinatier
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

Study AnnotationsStudy Notes

Notes added here are public and can be viewed by anyone. Notes added here are only available to you and those who you share with.

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.