Interactive Guidance Therapy With Video Feed-back of Parent and Child With Autism Spectrum Disorder
- Conditions
- Autism Spectrum Disorders
- Interventions
- Behavioral: Baseline sessions TAUBehavioral: Interactive guidance therapyDiagnostic Test: Developmental and diagnostic assessmentsBehavioral: Developmental assessment -Parental scalesBehavioral: Qualitative analysis
- Registration Number
- NCT04607616
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 24
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 3 baselines sessions Treatment As Usual (TAU) Baseline sessions TAU Patients received 3 baseline sessions before interactive guidance therapy 3 baselines sessions Treatment As Usual (TAU) Qualitative analysis Patients received 3 baseline sessions before interactive guidance therapy 5 baselines sessions TAU Qualitative analysis Patients received 5 baseline sessions before interactive guidance therapy 5 baselines sessions TAU Interactive guidance therapy Patients received 5 baseline sessions before interactive guidance therapy 7 baselines sessions TAU Baseline sessions TAU Patients received 7 baseline sessions before interactive guidance therapy 3 baselines sessions Treatment As Usual (TAU) Developmental and diagnostic assessments Patients received 3 baseline sessions before interactive guidance therapy 3 baselines sessions Treatment As Usual (TAU) Developmental assessment -Parental scales Patients received 3 baseline sessions before interactive guidance therapy 4 baselines sessions TAU Developmental and diagnostic assessments Patients received 4 baseline sessions before interactive guidance therapy 5 baselines sessions TAU Baseline sessions TAU Patients received 5 baseline sessions before interactive guidance therapy 5 baselines sessions TAU Developmental and diagnostic assessments Patients received 5 baseline sessions before interactive guidance therapy 5 baselines sessions TAU Developmental assessment -Parental scales Patients received 5 baseline sessions before interactive guidance therapy 6 baselines sessions TAU Developmental and diagnostic assessments Patients received 6 baseline sessions before interactive guidance therapy 6 baselines sessions TAU Developmental assessment -Parental scales Patients received 6 baseline sessions before interactive guidance therapy 7 baselines sessions TAU Developmental and diagnostic assessments Patients received 7 baseline sessions before interactive guidance therapy 7 baselines sessions TAU Developmental assessment -Parental scales Patients received 7 baseline sessions before interactive guidance therapy 8 baselines sessions TAU Baseline sessions TAU Patients received 8 baseline sessions before interactive guidance therapy 4 baselines sessions TAU Developmental assessment -Parental scales Patients received 4 baseline sessions before interactive guidance therapy 4 baselines sessions TAU Qualitative analysis Patients received 4 baseline sessions before interactive guidance therapy 3 baselines sessions Treatment As Usual (TAU) Interactive guidance therapy Patients received 3 baseline sessions before interactive guidance therapy 4 baselines sessions TAU Interactive guidance therapy Patients received 4 baseline sessions before interactive guidance therapy 6 baselines sessions TAU Baseline sessions TAU Patients received 6 baseline sessions before interactive guidance therapy 4 baselines sessions TAU Baseline sessions TAU Patients received 4 baseline sessions before interactive guidance therapy 6 baselines sessions TAU Interactive guidance therapy Patients received 6 baseline sessions before interactive guidance therapy 6 baselines sessions TAU Qualitative analysis Patients received 6 baseline sessions before interactive guidance therapy 7 baselines sessions TAU Interactive guidance therapy Patients received 7 baseline sessions before interactive guidance therapy 8 baselines sessions TAU Developmental and diagnostic assessments Patients received 8 baseline sessions before interactive guidance therapy 7 baselines sessions TAU Qualitative analysis Patients received 7 baseline sessions before interactive guidance therapy 8 baselines sessions TAU Developmental assessment -Parental scales Patients received 8 baseline sessions before interactive guidance therapy 8 baselines sessions TAU Qualitative analysis Patients received 8 baseline sessions before interactive guidance therapy 8 baselines sessions TAU Interactive guidance therapy Patients received 8 baseline sessions before interactive guidance therapy
- Primary Outcome Measures
Name Time Method Percentage of time spent in a joint attention situation Up to 15 months Supported Joint Attention (SUJ) rate is evaluated during the parents-child play-time
- Secondary Outcome Measures
Name Time Method Parent-child interactive features / Parental synchrony Up to 15 months - number of parental responses in synchrony with child
Child development / IFDC Up to 15 months - IFDC is French adaptation of MacArthur-Bates Communicative Development Inventories evaluated at inclusion visit, guidance session 1, guidance session 10 and guidance session 15
Parent-child interactive features/ joint attention Up to 15 months - SUJ and COJ rate initiated by child
Parent-child interactive features / Initiation of communication Up to 15 months - Initiation of communication by the child with the parent : in proportion to the child's acts of communication
Autistic Symptoms / CARS Up to 15 months CARS is Childhood Autism Rating Scale evaluated at inclusion visit, guidance session 1, guidance session 10 and guidance session 15
Parent-child interactive features / DCMA scale Up to 15 months - DCMA: dyadic communication measure in autism
Autistic Symptoms ECAR Up to 15 months ECA R is "Evaluation des comportements autistiques Révisée" Scale evaluated at inclusion visit, guidance session 1, guidance session 10 and guidance session 15
Parent-child interactive features / Communication Up to 15 months - Number conversational turns of speech between the child and the parent
Child development / MSEL Up to 15 months - MSEL : is Mullen Scale of Early Learning evaluated at inclusion visit, guidance session 1, guidance session 10 and guidance session 15
Child development / CDI Up to 15 months - CDI is Child Development Inventory evaluated at inclusion visit, guidance session 1, guidance session 10 and guidance session 15
Autistic Symptoms ADOS-2 Up to 15 months ADOS-2 is Autism diagnostic observation Schedule evaluated at inclusion visit, guidance session 1, guidance session 10 and guidance session 15
Content analysis of guidance session by parent At 16 months Targeted interview of parents with the psychologist on the content of guidance session
Adaptive behavior of the child Up to 15 months Vineland 2 Scale evaluated at inclusion visit, guidance session 1, guidance session 10 and guidance session 15
Autistic Symptoms ADIR Up to 15 months ADI R is Autism Diagnosis Interview Revised evaluated at inclusion visit, guidance session 1, guidance session 10 and guidance session 15
Change process Up to 15 months Psychotherapy Process Q-set evaluated at baseline visit 1 and last baseline visit (depend of randomization), guidance session 1 and guidance session 10
Trial Locations
- Locations (4)
Hôpital Necker Enfants Malades
🇫🇷Paris, France
Hôpital Saint Eloi
🇫🇷Montpellier, France
Hôpital Ville Evrard
🇫🇷Montreuil, France
Hôpital Pitié Salpétriere
🇫🇷Paris, France