NCT06443320

Brief Summary

Autism spectrum disorder (ASD) is a neurodevelopmental disorder (Valerie, Sperenza, 2009) that begins early in development, characterized by persistent deficits in communication and social interactions across various contexts and restricted, repetitive patterns of behavior, interests, or activities. These symptoms significantly impact social, school/professional functioning, or other important areas and are not better explained by intellectual disability or global developmental delay (American Psychiatric Association, 2013).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
10mo left

Started Dec 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress76%
Dec 2023Mar 2027

Study Start

First participant enrolled

December 4, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 30, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 5, 2024

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 4, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 4, 2027

Last Updated

February 6, 2025

Status Verified

February 1, 2025

Enrollment Period

3.2 years

First QC Date

May 30, 2024

Last Update Submit

February 4, 2025

Conditions

Keywords

autismvideodrama

Outcome Measures

Primary Outcomes (1)

  • Dunn Sensory Profile questionnaire

    Sensory atypicality frequency will be assessed using the Dunn Sensory Profile questionnaire, describing child behavior in various sensory experiences

    9 months

Secondary Outcomes (2)

  • Cars-T questionnaire

    9 months

  • Sceno Test

    9 months

Study Arms (2)

Group of young ASD patients receiving videodrama sessions and interviews

EXPERIMENTAL

Children participating in videodrama sessions, one per week for 9 sessions.

Other: patient included in experimental groupe will view the video excerpt, a playtime, a drawing activities

Cohort of ASD patients not receiving videodrama but receiving care in participating units

NO INTERVENTION

Patients included in the cohort will be managed as part of their routine care

Interventions

Patients included in the videodrama arm will participate in a total of 18 videodrama sessions, with one session per week. Each session will include a patient welcome period, the viewing of a video excerpt (in slow motion or not), a playtime, a drawing period, and a group closing session. For the play and drawing activities, the same materials will be provided in each department and for each group, including small figurines, animals, shapes (such as cubes, triangles, circles), small plush toys, markers, colored pencils, and A4 white sheets of paper.

Group of young ASD patients receiving videodrama sessions and interviews

Eligibility Criteria

Age3 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children aged 3 to 15 years.
  • Clinically confirmed ASD by a psychiatrist.
  • Parental or legal guardian consent for participation.
  • Child showing a strong interest in screens and/or video content.
  • Ability to tolerate the presence of other children.
  • Minimum of 18 video drama sessions.
  • Not having benefited from disease care in the past.
  • Affiliation to a social security system

You may not qualify if:

  • No ASD diagnosis.
  • Younger than 3 or older than 15 at the study start.
  • No interest in screens or video content.
  • Parental or legal guardian refusal for participation.
  • Dropping out before completing 18 sessions.
  • Patient having benefited a disease care in the past

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHI Robert Ballanger

Aulnay-sous-Bois, 93600, France

RECRUITING

MeSH Terms

Conditions

Autism Spectrum DisorderAutistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2024

First Posted

June 5, 2024

Study Start

December 4, 2023

Primary Completion (Estimated)

March 4, 2027

Study Completion (Estimated)

March 4, 2027

Last Updated

February 6, 2025

Record last verified: 2025-02

Locations