Interactive Guidance Therapy With Video Feed-back of Parent and Child With Autism Spectrum Disorder

Autism Spectrum Disorders Clinical Trial

— GIETSA  

Official title:

Interactive Guidance Therapy With Video Feed-back of Parent and Child With Autism Spectrum Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04607616
• Other study ID #: APHP180671
• Secondary ID: 2019-A02707-50
• Status: Recruiting
• Phase: N/A
• Start date: March 26, 2021
• Est. completion date: January 2026

Study information

• Verified date: December 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Lisa OUSS, MD
• Phone: +33 1 44 49 45 61
• Email: lisa.ouss[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: January 2026
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Months to 3 Years

Eligibility

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)

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autism Spectrum Disorders
• Autistic Disorder
• Child Development Disorders, Pervasive

Intervention

Behavioral:
• Baseline sessions TAU
TAU consists of sessions lasting around one/one and a half hour ; the consultant is practicing as usual. The interventions focus on child's behavior, parent infant relationship, with moments of play with the child, advices, informations about child development and Autism.
• Interactive guidance therapy
The objective is to reinforce the identification, deciphering, interpretation, and answer to child's signals by the parent, in order to to promote a synchronous and attuned response to the child's needs. Sessions last around one/one and a half hour. Parent plays 7-10 minutes with the child, in the presence of the therapist, with toys chosen according to the child's developmental stage. Then therapist proposes an immediate viewing of the play session. The therapist selects short moments of positive interaction. He has determined a " focus ", depending on the play, previous sessions, the child's difficulties and parent's interventions. He accompanies, guides and supports the parent to describe the interaction, the alternance in play, joint attention, shared affect, in a co-construction: the parent discovers the child's and his own skills.

Diagnostic Test:
• Developmental and diagnostic assessments
MSEL, CARS, ECAR, CIM10, DMS5, ADOS, ADIR

Behavioral:
• Developmental assessment -Parental scales
Vineland II, IFDC, IDE
• Qualitative analysis
Interpretative Phenomenological Analysis. Parents' semi structured interview about the Interactive Guidance experience. Qualitative analysis of transcripts (recurrent themes, meta themes).

Locations

Country	Name	City	State
France	Hôpital Saint Eloi	Montpellier
France	Hôpital Ville Evrard	Montreuil
France	Hôpital Necker Enfants Malades	Paris
France	Hôpital Pitié Salpétriere	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Ville Evrard Hospital

Country where clinical trial is conducted

France, 

References & Publications (3)

1. McDonough S. Interaction guidance. Treat Parent-infant Relatsh Probl Strateg Interv. 2004;79-96.

2. McDonough SC. Promoting positive early parent-infant relationships through interaction guidance. Child Adolesc Psychiatr Clin N Am. 1995;4(3):661-72.

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of time spent in a joint attention situation	Coordinated Joint Attention (COJ) rate is evaluated during the parents-child play-time	Up to 15 months
Primary	Percentage of time spent in a joint attention situation	Supported Joint Attention (SUJ) rate is evaluated during the parents-child play-time	Up to 15 months
Secondary	Parent-child interactive features/ joint attention	- SUJ and COJ rate initiated by child	Up to 15 months
Secondary	Parent-child interactive features / DCMA scale	- DCMA: dyadic communication measure in autism	Up to 15 months
Secondary	Parent-child interactive features / Parental synchrony	- number of parental responses in synchrony with child	Up to 15 months
Secondary	Parent-child interactive features / Communication	- Number conversational turns of speech between the child and the parent	Up to 15 months
Secondary	Parent-child interactive features / Initiation of communication	- Initiation of communication by the child with the parent : in proportion to the child's acts of communication	Up to 15 months
Secondary	Child development / MSEL	- MSEL : is Mullen Scale of Early Learning evaluated at inclusion visit, guidance session 1, guidance session 10 and guidance session 15	Up to 15 months
Secondary	Child development / CDI	- CDI is Child Development Inventory evaluated at inclusion visit, guidance session 1, guidance session 10 and guidance session 15	Up to 15 months
Secondary	Child development / IFDC	- IFDC is French adaptation of MacArthur-Bates Communicative Development Inventories evaluated at inclusion visit, guidance session 1, guidance session 10 and guidance session 15	Up to 15 months
Secondary	Autistic Symptoms / CARS	CARS is Childhood Autism Rating Scale evaluated at inclusion visit, guidance session 1, guidance session 10 and guidance session 15	Up to 15 months
Secondary	Autistic Symptoms ECAR	ECA R is "Evaluation des comportements autistiques Révisée" Scale evaluated at inclusion visit, guidance session 1, guidance session 10 and guidance session 15	Up to 15 months
Secondary	Autistic Symptoms ADOS-2	ADOS-2 is Autism diagnostic observation Schedule evaluated at inclusion visit, guidance session 1, guidance session 10 and guidance session 15	Up to 15 months
Secondary	Autistic Symptoms ADIR	ADI R is Autism Diagnosis Interview Revised evaluated at inclusion visit, guidance session 1, guidance session 10 and guidance session 15	Up to 15 months
Secondary	Adaptive behavior of the child	Vineland 2 Scale evaluated at inclusion visit, guidance session 1, guidance session 10 and guidance session 15	Up to 15 months
Secondary	Change process	Psychotherapy Process Q-set evaluated at baseline visit 1 and last baseline visit (depend of randomization), guidance session 1 and guidance session 10	Up to 15 months
Secondary	Content analysis of guidance session by parent	Targeted interview of parents with the psychologist on the content of guidance session	At 16 months