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NCT Number: NCT04607616

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 month–3 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Saint Eloi, Montpellier, France

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Baseline sessions TAU

Behavioral

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

Behavioral

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.

Developmental and diagnostic assessments

Diagnostic Test

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

Developmental assessment -Parental scales

Behavioral

Vineland II, IFDC, IDE

Qualitative analysis

Behavioral

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

Primary outcomes

  1. Percentage of time spent in a joint attention situation

    Time frame: Up to 15 months

    Coordinated Joint Attention (COJ) rate is evaluated during the parents-child play-time

  2. Percentage of time spent in a joint attention situation

    Time frame: Up to 15 months

    Supported Joint Attention (SUJ) rate is evaluated during the parents-child play-time

Secondary outcomes

  1. Parent-child interactive features/ joint attention

    Time frame: Up to 15 months

    • SUJ and COJ rate initiated by child
  2. Parent-child interactive features / DCMA scale

    Time frame: Up to 15 months

    • DCMA: dyadic communication measure in autism
  3. Parent-child interactive features / Parental synchrony

    Time frame: Up to 15 months

    • number of parental responses in synchrony with child
  4. Parent-child interactive features / Communication

    Time frame: Up to 15 months

    • Number conversational turns of speech between the child and the parent
  5. Parent-child interactive features / Initiation of communication

    Time frame: Up to 15 months

    • Initiation of communication by the child with the parent : in proportion to the child's acts of communication
  6. Child development / MSEL

    Time frame: 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
  7. Child development / CDI

    Time frame: Up to 15 months

    • CDI is Child Development Inventory evaluated at inclusion visit, guidance session 1, guidance session 10 and guidance session 15
  8. Child development / IFDC

    Time frame: 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
  9. Autistic Symptoms / CARS

    Time frame: Up to 15 months

    CARS is Childhood Autism Rating Scale evaluated at inclusion visit, guidance session 1, guidance session 10 and guidance session 15

  10. Autistic Symptoms ECAR

    Time frame: 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

  11. Autistic Symptoms ADOS-2

    Time frame: 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

  12. Autistic Symptoms ADIR

    Time frame: 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

  13. Adaptive behavior of the child

    Time frame: Up to 15 months

    Vineland 2 Scale evaluated at inclusion visit, guidance session 1, guidance session 10 and guidance session 15

  14. Change process

    Time frame: 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

  15. Content analysis of guidance session by parent

    Time frame: At 16 months

    Targeted interview of parents with the psychologist on the content of guidance session

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin
  • Ville Evrard Hospital

Registry information

Acronym: GIETSA

Important dates

Study start
2021
Primary completion
2022
Study completion
2026
First posted
Oct 29, 2020
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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