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

Primary Purpose

Autism Spectrum Disorders

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Baseline sessions TAU
Interactive guidance therapy
Developmental and diagnostic assessments
Developmental assessment -Parental scales
Qualitative analysis
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Autism Spectrum Disorders focused on measuring Autism Spectrum Disorders, Interactive guidance therapy, Video feed-back

Eligibility Criteria

18 Months - 3 Years (Child)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Hôpital Necker Enfants MaladesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

3 baselines sessions Treatment As Usual (TAU)

4 baselines sessions TAU

5 baselines sessions TAU

6 baselines sessions TAU

7 baselines sessions TAU

8 baselines sessions TAU

Arm Description

Patients received 3 baseline sessions before interactive guidance therapy

Patients received 4 baseline sessions before interactive guidance therapy

Patients received 5 baseline sessions before interactive guidance therapy

Patients received 6 baseline sessions before interactive guidance therapy

Patients received 7 baseline sessions before interactive guidance therapy

Patients received 8 baseline sessions before interactive guidance therapy

Outcomes

Primary Outcome Measures

Percentage of time spent in a joint attention situation
Coordinated Joint Attention (COJ) rate is evaluated during the parents-child play-time
Percentage of time spent in a joint attention situation
Supported Joint Attention (SUJ) rate is evaluated during the parents-child play-time

Secondary Outcome Measures

Parent-child interactive features/ joint attention
- SUJ and COJ rate initiated by child
Parent-child interactive features / DCMA scale
- DCMA: dyadic communication measure in autism
Parent-child interactive features / Parental synchrony
- number of parental responses in synchrony with child
Parent-child interactive features / Communication
- Number conversational turns of speech between the child and the parent
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
Child development / MSEL
- MSEL : is Mullen Scale of Early Learning evaluated at inclusion visit, guidance session 1, guidance session 10 and guidance session 15
Child development / CDI
- CDI is Child Development Inventory evaluated at inclusion visit, guidance session 1, guidance session 10 and guidance session 15
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
Autistic Symptoms / CARS
CARS is Childhood Autism Rating Scale evaluated at inclusion visit, guidance session 1, guidance session 10 and guidance session 15
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
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
Autistic Symptoms ADIR
ADI R is Autism Diagnosis Interview Revised evaluated at inclusion visit, guidance session 1, guidance session 10 and guidance session 15
Adaptive behavior of the child
Vineland 2 Scale evaluated at inclusion visit, guidance session 1, guidance session 10 and guidance session 15
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
Content analysis of guidance session by parent
Targeted interview of parents with the psychologist on the content of guidance session

Full Information

First Posted
July 1, 2020
Last Updated
July 12, 2022
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Ville Evrard Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04607616
Brief Title
Interactive Guidance Therapy With Video Feed-back of Parent and Child With Autism Spectrum Disorder
Acronym
GIETSA
Official Title
Interactive Guidance Therapy With Video Feed-back of Parent and Child With Autism Spectrum Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 26, 2021 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Ville Evrard Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorders
Keywords
Autism Spectrum Disorders, Interactive guidance therapy, Video feed-back

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
3 baselines sessions Treatment As Usual (TAU)
Arm Type
Experimental
Arm Description
Patients received 3 baseline sessions before interactive guidance therapy
Arm Title
4 baselines sessions TAU
Arm Type
Experimental
Arm Description
Patients received 4 baseline sessions before interactive guidance therapy
Arm Title
5 baselines sessions TAU
Arm Type
Experimental
Arm Description
Patients received 5 baseline sessions before interactive guidance therapy
Arm Title
6 baselines sessions TAU
Arm Type
Experimental
Arm Description
Patients received 6 baseline sessions before interactive guidance therapy
Arm Title
7 baselines sessions TAU
Arm Type
Experimental
Arm Description
Patients received 7 baseline sessions before interactive guidance therapy
Arm Title
8 baselines sessions TAU
Arm Type
Experimental
Arm Description
Patients received 8 baseline sessions before interactive guidance therapy
Intervention Type
Behavioral
Intervention Name(s)
Baseline sessions TAU
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Interactive guidance therapy
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Developmental and diagnostic assessments
Intervention Description
MSEL, CARS, ECAR, CIM10, DMS5, ADOS, ADIR
Intervention Type
Behavioral
Intervention Name(s)
Developmental assessment -Parental scales
Intervention Description
Vineland II, IFDC, IDE
Intervention Type
Behavioral
Intervention Name(s)
Qualitative analysis
Intervention Description
Interpretative Phenomenological Analysis. Parents' semi structured interview about the Interactive Guidance experience. Qualitative analysis of transcripts (recurrent themes, meta themes).
Primary Outcome Measure Information:
Title
Percentage of time spent in a joint attention situation
Description
Coordinated Joint Attention (COJ) rate is evaluated during the parents-child play-time
Time Frame
Up to 15 months
Title
Percentage of time spent in a joint attention situation
Description
Supported Joint Attention (SUJ) rate is evaluated during the parents-child play-time
Time Frame
Up to 15 months
Secondary Outcome Measure Information:
Title
Parent-child interactive features/ joint attention
Description
- SUJ and COJ rate initiated by child
Time Frame
Up to 15 months
Title
Parent-child interactive features / DCMA scale
Description
- DCMA: dyadic communication measure in autism
Time Frame
Up to 15 months
Title
Parent-child interactive features / Parental synchrony
Description
- number of parental responses in synchrony with child
Time Frame
Up to 15 months
Title
Parent-child interactive features / Communication
Description
- Number conversational turns of speech between the child and the parent
Time Frame
Up to 15 months
Title
Parent-child interactive features / Initiation of communication
Description
- Initiation of communication by the child with the parent : in proportion to the child's acts of communication
Time Frame
Up to 15 months
Title
Child development / MSEL
Description
- MSEL : is Mullen Scale of Early Learning evaluated at inclusion visit, guidance session 1, guidance session 10 and guidance session 15
Time Frame
Up to 15 months
Title
Child development / CDI
Description
- CDI is Child Development Inventory evaluated at inclusion visit, guidance session 1, guidance session 10 and guidance session 15
Time Frame
Up to 15 months
Title
Child development / IFDC
Description
- IFDC is French adaptation of MacArthur-Bates Communicative Development Inventories evaluated at inclusion visit, guidance session 1, guidance session 10 and guidance session 15
Time Frame
Up to 15 months
Title
Autistic Symptoms / CARS
Description
CARS is Childhood Autism Rating Scale evaluated at inclusion visit, guidance session 1, guidance session 10 and guidance session 15
Time Frame
Up to 15 months
Title
Autistic Symptoms ECAR
Description
ECA R is "Evaluation des comportements autistiques Révisée" Scale evaluated at inclusion visit, guidance session 1, guidance session 10 and guidance session 15
Time Frame
Up to 15 months
Title
Autistic Symptoms ADOS-2
Description
ADOS-2 is Autism diagnostic observation Schedule evaluated at inclusion visit, guidance session 1, guidance session 10 and guidance session 15
Time Frame
Up to 15 months
Title
Autistic Symptoms ADIR
Description
ADI R is Autism Diagnosis Interview Revised evaluated at inclusion visit, guidance session 1, guidance session 10 and guidance session 15
Time Frame
Up to 15 months
Title
Adaptive behavior of the child
Description
Vineland 2 Scale evaluated at inclusion visit, guidance session 1, guidance session 10 and guidance session 15
Time Frame
Up to 15 months
Title
Change process
Description
Psychotherapy Process Q-set evaluated at baseline visit 1 and last baseline visit (depend of randomization), guidance session 1 and guidance session 10
Time Frame
Up to 15 months
Title
Content analysis of guidance session by parent
Description
Targeted interview of parents with the psychologist on the content of guidance session
Time Frame
At 16 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Months
Maximum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lisa OUSS, MD
Phone
+33 1 44 49 45 61
Email
lisa.ouss@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Laure CHOUPEAUX, Master
Phone
+33 1 44 38 17 11
Email
laure.choupeaux@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benoit QUIROT, MD
Organizational Affiliation
EPS Ville Evrard
Official's Role
Study Director
Facility Information:
Facility Name
Hôpital Necker Enfants Malades
City
Paris
ZIP/Postal Code
75015
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
lisa OUSS, MD
Phone
+33 1 44 49 45 61
Email
lisa.ouss@aphp.fr

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
1. McDonough S. Interaction guidance. Treat Parent-infant Relatsh Probl Strateg Interv. 2004;79-96.
Results Reference
background
Citation
2. McDonough SC. Promoting positive early parent-infant relationships through interaction guidance. Child Adolesc Psychiatr Clin N Am. 1995;4(3):661-72.
Results Reference
background
PubMed Identifier
19486848
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.
Results Reference
background

Learn more about this trial

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

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