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

NCT04244721 | Recruiting DMC

• 1 other identifier: 2018-A02516-49
• Study Type: interventional
• Target: 212
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder

Keywords

interventions Early Start Denver Model (ESDM); Preschool Autism Communication Therapy (PACT)

Outcome Measures

Primary Outcomes (1)

• Autism severity

  Change between baseline and 12 months in the overall raw score at ADOS-2 (Autism Diagnostic Observation Schedule version 2), Module 1

  12 months

Secondary Outcomes (8)

• Social Interactions of the child

  6 and 12 months

• Parent-child synchrony and initiative in communication

  6 and 12 months

• Number of words produced by the child

  12 months

• Number of words produced by the child

  12 months

• Adaptative behavior

  12 months

Study Arms (2)

a group of children receiving the usual therapy (TAU)

SHAM COMPARATOR

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

Other: Treatment As Usual (TAU)

a group of children receiving TAU plus the PACT intervention.

EXPERIMENTAL

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.

Other: Preschool Autism Communication Therapy (PACT)

Interventions

Preschool Autism Communication Therapy (PACT) 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.

a group of children receiving TAU plus the PACT intervention.

Treatment As Usual (TAU) OTHER

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

a group of children receiving the usual therapy (TAU)

Eligibility Criteria

• Age: 18 Months - 36 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hôpital le Vinatier: lead

Study Sites (1)

Hopital Vinatier

Bron, 69678, France

RECRUITING

Related Publications (1)

• 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.

  PMID: 33827837 DERIVED

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Central Study Contacts

Lydie SARTELET

CONTACT

0437915531; lydie.sartelet@ch-le-vinatier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 21, 2020
• First Posted: January 28, 2020
• Study Start: June 30, 2020
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: July 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)