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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04607616
Acronym
GIETSA
Enrollment
27
Registered
2020-10-29
Start date
2021-03-26
Completion date
2026-05-01
Last updated
2026-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism Spectrum Disorders

Keywords

Autism Spectrum Disorders, Interactive guidance therapy, Video feed-back

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

Interventions

BEHAVIORALBaseline 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.

BEHAVIORALInteractive 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_TESTDevelopmental and diagnostic assessments

MSEL, CARS, ECAR, CIM10, DMS5, ADOS, ADIR

BEHAVIORALDevelopmental assessment -Parental scales

Vineland II, IFDC, IDE

Interpretative Phenomenological Analysis. Parents' semi structured interview about the Interactive Guidance experience. Qualitative analysis of transcripts (recurrent themes, meta themes).

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER
Ville Evrard Hospital
CollaboratorUNKNOWN
URC-CIC Paris Descartes Necker Cochin
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Months to 3 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Percentage of time spent in a joint attention situationUp to 15 monthsCoordinated Joint Attention (COJ) rate is evaluated during the parents-child play-time

Secondary

MeasureTime frameDescription
Parent-child interactive features/ joint attentionUp to 15 months\- SUJ and COJ rate initiated by child
Parent-child interactive features / DCMA scaleUp to 15 months\- DCMA: dyadic communication measure in autism
Parent-child interactive features / Parental synchronyUp to 15 months\- number of parental responses in synchrony with child
Parent-child interactive features / CommunicationUp to 15 months\- Number conversational turns of speech between the child and the parent
Parent-child interactive features / Initiation of communicationUp to 15 months\- Initiation of communication by the child with the parent : in proportion to the child's acts of communication
Child development / MSELUp 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 / CDIUp to 15 months\- CDI is Child Development Inventory evaluated at inclusion visit, guidance session 1, guidance session 10 and guidance session 15
Child development / IFDCUp 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
Autistic Symptoms / CARSUp to 15 monthsCARS is Childhood Autism Rating Scale evaluated at inclusion visit, guidance session 1, guidance session 10 and guidance session 15
Autistic Symptoms ECARUp to 15 monthsECA R is "Evaluation des comportements autistiques Révisée" Scale evaluated at inclusion visit, guidance session 1, guidance session 10 and guidance session 15
Autistic Symptoms ADOS-2Up to 15 monthsADOS-2 is Autism diagnostic observation Schedule evaluated at inclusion visit, guidance session 1, guidance session 10 and guidance session 15
Autistic Symptoms ADIRUp to 15 monthsADI R is Autism Diagnosis Interview Revised evaluated at inclusion visit, guidance session 1, guidance session 10 and guidance session 15
Adaptive behavior of the childUp to 15 monthsVineland 2 Scale evaluated at inclusion visit, guidance session 1, guidance session 10 and guidance session 15
Change processUp to 15 monthsPsychotherapy Process Q-set evaluated at baseline visit 1 and last baseline visit (depend of randomization), guidance session 1 and guidance session 10
Content analysis of guidance session by parentAt 16 monthsTargeted interview of parents with the psychologist on the content of guidance session

Countries

France

Contacts

STUDY_DIRECTORBenoit QUIROT, MD

EPS Ville Evrard

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 7, 2026