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EVALUATION for YOUNG CHILDREN with AUTISM SPECTRUM DISORDERS (coquille)

C

Centre hospitalier de Ville-Evrard, France

Status

Active, not recruiting

Conditions

Autism Spectrum Disorder

Treatments

Device: coquille

Study type

Interventional

Funder types

Other

Identifiers

NCT06867783
10477M-COQUILLE

Details and patient eligibility

About

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

Full 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.

Enrollment

29 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

29 participants in 1 patient group

coquille device
Other group
Description:
collaborative family support scheme aimed at improving family functioning and child behaviour
Treatment:
Device: coquille

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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