Clinical trial NCT06867783: EVALUATION FOR YOUNG CHILDREN WITH AUTISM SPECTRUM DISORDERS
Official title: EVALUATION OF EARLY FAMILY AND MULTIFAMILY INTERVENTION FOR YOUNG CHILDREN WITH AUTISM SPECTRUM DISORDERS
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: Autism Spectrum Disorder - coquille device
Lead sponsor: Centre hospitalier de Ville-Evrard, France
Sponsor class: OTHER
First posted: 2025-03-10
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: In this context, an innovative early-stage device was launched in the fall of 2022 at the Coquille unit of the Ville Evrard Public Health Establishment (EPSVE), for children under 30 months with Autism Spectrum Disorder and their families.

This six-month therapeutic device in day hospital includes:

* 22 TMF sessions,
* four two-family observation sessions,
* three sessions of four unique family sessions,
* the possibilities of individual targeted intervention in case of need estimated by families and/or caregivers.
Primary purpose: OTHER

Brief summary: Collaborative early management of children under 30 months with autism spectrum disorder and their families in an ambulatory child psychiatry unit.

Detailed description: Early intervention in Autism Spectrum Disorder (ASD) is now considered a priority. An approach that targets both child disorders and parental distress, and supports the skills of parents, is desirable. Yet there is no early intervention by the ASD involving parents and targeting both child functioning and parenting skills specifically.

Our objective is to evaluate quantitatively and qualitatively the collaborative family support system for ASD "Coquille". This scheme combines the development of a personalized care project based on parents' priorities, an intensive single-family parent-child follow-up and a group of multi-family therapy , over a total period of 6 months. Our main hypothesis is the significant decrease in behavioral disorders of children, evaluated by CARS, following the Coquille device. Our secondary hypotheses concern the evolution of parental dimensions following the device (sense of coherence, parental skills, parental stress, coping strategies and social support). We assume that these dimensions will change as a result of the scheme, and that they will be maintained in the medium term, six months after Coquille. A semi-structured interview will qualitatively explore the dimensions related to family resources, before and after the follow-up and in the medium term. This will also allow the mother to collect experience of the device.

Eligibility criteria: Inclusion Criteria for the mother and the child:

* Age 18 years and over
* French language spoken and written by the parent
* Free and informed consent form , initialled and signed by the parent
* Child under 30 months of age at time of inclusion, diagnosed with autism spectrum disorder
* Total CARS score greater than or equal to 30
* Free and informed consent form, initialled and signed by legal representatives

Exclusion Criteria for the mother only:

* Any acute, somatic or psychiatric clinical condition of the mother not compatible with therapeutic intervention.
* Current engagement in an interventional research protocol
* Mother under protection of justice, guardianship or enhanced curatorship
* Mother no longer having parental authority

Primary outcomes:
measure: Childhood Autism Rating, Scale, CARS
timeFrame: It is done before the sign of the consent (T-1),
measure: Childhood Autism Rating, Scale, CARS
timeFrame: Six month after the use of coquille device (T1)
measure: Childhood Autism Rating, Scale, CARS
timeFrame: Six month after the follow up (T2)
measure: Sociodemographic and lifestyle
timeFrame: Immediately after the sign of the consent (T0)
measure: Sociodemographic and lifestyle
timeFrame: Six month after the use of coquille device (T1)
measure: Sociodemographic and lifestyle
timeFrame: Six month after the follow up (T2)
measure: Parental Stress Scale
timeFrame: Immediately after the sign of the consent (T0)
measure: Parental Stress Scale
timeFrame: Six month after the use of coquille device (T1)
measure: Parental Stress Scale
timeFrame: Six month after the follow up (T2)
measure: Ways of Coping Checklist
timeFrame: Immediately after the sign of the consent (T0)
measure: Ways of Coping Checklist
timeFrame: Six month after the use of coquille device (T1)
measure: Ways of Coping Checklist
timeFrame: Six month after the follow up (T2)
measure: sense of coherence scale
timeFrame: Immediately after the sign of the consent (T0)
measure: sense of coherence scale
timeFrame: Six month after the use of coquille device (T1)
measure: sense of coherence scale
timeFrame: Six month after the follow up (T2)
measure: Parent Sense of Competency Scale (PSOC)
timeFrame: Immediately after the sign of the consent (T0)
measure: Parent Sense of Competency Scale (PSOC)
timeFrame: Six month after the use of coquille device (T1)
measure: Parent Sense of Competency Scale (PSOC)
timeFrame: Six month after the follow up (T2)
measure: Multidimensional Scale of Perceived Social Support (MSPSS)
timeFrame: Immediately after the sign of the consent (T0)
measure: Multidimensional Scale of Perceived Social Support (MSPSS)
timeFrame: Six month after the use of coquille device (T1)
measure: Multidimensional Scale of Perceived Social Support (MSPSS)
timeFrame: Six month after the follow up (T2)
measure: The Marlowe-Crowne Social Desirability Scale (MC-SDS)
timeFrame: Immediately after the sign of the consent (T0)
measure: The Marlowe-Crowne Social Desirability Scale (MC-SDS)
timeFrame: Six month after the use of coquille device (T1)
measure: The Marlowe-Crowne Social Desirability Scale (MC-SDS)
timeFrame: Six month after the follow up (T2)
measure: Aberrant Behavior Checklist
timeFrame: Immediately after the sign of the consent (T0)
measure: Aberrant Behavior Checklist
timeFrame: Six month after the use of coquille device (T1)
measure: Aberrant Behavior Checklist
timeFrame: Six month after the follow up (T2)
Secondary outcomes:
Other outcomes:
Locations:
city: Neuilly-sur-Marne
country: France
facility: Eps Ville Evrard
Study officials:
affiliation: EPS VILLE EVRARD
name: Pierre LECARPENTIER, MBBS
role: PRINCIPAL_INVESTIGATOR
References: