Clinical trial NCT04607616: Interactive Guidance Therapy With Video Feed-back of Parent and Child With Autism Spectrum Disorder
Official title: Interactive Guidance Therapy With Video Feed-back of Parent and Child With Autism Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorders
Keywords: Autism Spectrum Disorders
Interactive guidance therapy
Video feed-back
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Ville Evrard Hospital
First posted: 2020-10-29
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to assess the effect of Interactive Guidance Therapy with video feed back (IGT) of parent and child with Autism Spectrum Disorder, under three years of age, using a Single Case Experimental Design (SCED) with multiple baseline across subjects, multicentric, randomized, with multiple replications, blinded scored

Detailed description: The purpose of this study is to assess the effect of Interactive Guidance Therapy with video feed back (IGT) of parent and child with Autism Spectrum Disorder, under three years of age, using a Single Case Experimental Design.

Early Interventions in Autism Spectrum Disorders (ASD) undergo a major development. The investigators identify three generations of early support: 1) Behavioral studies ; 2) Early Intensive Behavioral Interventions (EIBI), inspired by ABA, focused on targeted ASD disorders 3) Naturalistic Behavioral Developmental Behavioral Interventions (NDBI), more ecological, focused on the child's skills.

Among them, methods of video feedback target parental sensitivity (identification, interpretation, response, contingency and synchrony). The VIPP (Video Interactive Positive Parenting) in children less than one year of age, has shown moderate and long term effects on parent-child interaction. The PACT (Preschool Autism Communication Trial) showed immediate and in the long term effects on the synchronization of the parental response, the child initiation, less importantly on the joint attention, and on the autistic symptoms. The dyadic communication allows for changes in autistic symptoms.

Interactive guidance is a brief video-feedback therapy, based on the analysis of "the here and now" with the parent (s), of videotaped interactions with their child. The objective is to strengthen parental skills, their sensitivity, their ability to decipher and respond to the specific needs of their child.

The interest of IGT in the field of ASD, compared to VIPP and PACT, is to offer a standardized feedback intervention adapted to each dyad, according to the child's and parents skills and difficulties, structured on the "here and now" more than on a predetermined sequence of goals.

The investigators use the Single Case Experimental Design (SCED) with multiple baseline across subjects, multicentric, randomized, with multiple replications, blinded scored.

They expect

* to improve the interactive and communicative basic skills of the child, soon after the ASD diagnosis, by accompanying the parents in the identification and understanding of their child's disorders.
* to propose a method highlighting parental skills, in a collaborative and pleasant way
* To increase the parental alliance in the implementation of a tailored intervention for the child
* To facilitate access to healthcare and reduce the parental wandering in the implementation of intervention

Eligibility criteria: Inclusion Criteria:

* 18 months to 3 years child at screening
* Child with a diagnosis of Autism Spectrum Disorder (DSM 5) or pervasive Developmental Disorder (ICD 10)
* Child with ADI R and ADOS-2 fulfilling the criteria for TSA / PDD at diagnosis
* Developmental age \> 12 months in motility with the Brunet-Lézine test
* Child with availability of parent most present in daily life, only this parent participating directly in play sessions
* Signed Informed consent form by both parents
* Patient affiliated to the health insurance system

Exclusion Criteria:

* Level of language in French of parents insufficient to benefit from the care and fill in the questionnaires
* Psychiatric parental pathology interfering with interactions with the child, qualitatively assessed by the referring psychiatrist
* Severe sensory illness of the child (blindness, deafness, degenerative disease)

Primary outcomes:
measure: Percentage of time spent in a joint attention situation
timeFrame: Up to 15 months
measure: Percentage of time spent in a joint attention situation
timeFrame: Up to 15 months
Secondary outcomes:
measure: Parent-child interactive features/ joint attention
timeFrame: Up to 15 months
measure: Parent-child interactive features / DCMA scale
timeFrame: Up to 15 months
measure: Parent-child interactive features / Parental synchrony
timeFrame: Up to 15 months
measure: Parent-child interactive features / Communication
timeFrame: Up to 15 months
measure: Parent-child interactive features / Initiation of communication
timeFrame: Up to 15 months
measure: Child development / MSEL
timeFrame: Up to 15 months
measure: Child development / CDI
timeFrame: Up to 15 months
measure: Child development / IFDC
timeFrame: Up to 15 months
measure: Autistic Symptoms / CARS
timeFrame: Up to 15 months
measure: Autistic Symptoms ECAR
timeFrame: Up to 15 months
measure: Autistic Symptoms ADOS-2
timeFrame: Up to 15 months
measure: Autistic Symptoms ADIR
timeFrame: Up to 15 months
measure: Adaptive behavior of the child
timeFrame: Up to 15 months
measure: Change process
timeFrame: Up to 15 months
measure: Content analysis of guidance session by parent
timeFrame: At 16 months
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Hôpital Saint Eloi
city: Montreuil
country: France
facility: Hôpital Ville Evrard
city: Paris
country: France
facility: Hôpital Pitié Salpétriere
city: Paris
country: France
facility: Hôpital Necker Enfants Malades
Study officials:
affiliation: EPS Ville Evrard
name: Benoit QUIROT, MD
role: STUDY_DIRECTOR
References:
citation: 1. McDonough S. Interaction guidance. Treat Parent-infant Relatsh Probl Strateg Interv. 2004;79-96.
citation: 2. McDonough SC. Promoting positive early parent-infant relationships through interaction guidance. Child Adolesc Psychiatr Clin N Am. 1995;4(3):661-72.
citation: Rusconi-Serpa S, Sancho Rossignol A, McDonough SC. Video feedback in parent-infant treatments. Child Adolesc Psychiatr Clin N Am. 2009 Jul;18(3):735-51. doi: 10.1016/j.chc.2009.02.009.