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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-A02707-50 | Other Identifier | ID-RCB |
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| Name | Class |
|---|---|
| Ville Evrard Hospital | UNKNOWN |
| URC-CIC Paris Descartes Necker Cochin | OTHER |
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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3 baselines sessions Treatment As Usual (TAU) | Experimental | Patients received 3 baseline sessions before interactive guidance therapy |
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| 4 baselines sessions TAU | Experimental | Patients received 4 baseline sessions before interactive guidance therapy |
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| 5 baselines sessions TAU | Experimental | Patients received 5 baseline sessions before interactive guidance therapy |
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| 6 baselines sessions TAU | Experimental | Patients received 6 baseline sessions before interactive guidance therapy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Parent-child interactive features/ joint attention | - SUJ and COJ rate initiated by child | Up to 15 months |
| Parent-child interactive features / DCMA scale | - DCMA: dyadic communication measure in autism |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Benoit QUIROT, MD | EPS Ville Evrard | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Saint Eloi | Montpellier | 34000 | France | |||
| Hôpital Ville Evrard |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 1. McDonough S. Interaction guidance. Treat Parent-infant Relatsh Probl Strateg Interv. 2004;79-96. | ||
| Background | 2. McDonough SC. Promoting positive early parent-infant relationships through interaction guidance. Child Adolesc Psychiatr Clin N Am. 1995;4(3):661-72. | ||
| 19486848 | Background | 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. |
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| 7 baselines sessions TAU | Experimental | Patients received 7 baseline sessions before interactive guidance therapy |
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| 8 baselines sessions TAU | Experimental | Patients received 8 baseline sessions before interactive guidance therapy |
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| 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. |
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| Developmental and diagnostic assessments | Diagnostic Test | MSEL, CARS, ECAR, CIM10, DMS5, ADOS, ADIR |
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| Developmental assessment -Parental scales | Behavioral | Vineland II, IFDC, IDE |
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| Qualitative analysis | Behavioral | Interpretative Phenomenological Analysis. Parents' semi structured interview about the Interactive Guidance experience. Qualitative analysis of transcripts (recurrent themes, meta themes). |
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| Up to 15 months |
| Parent-child interactive features / Parental synchrony | - number of parental responses in synchrony with child | Up to 15 months |
| Parent-child interactive features / Communication | - Number conversational turns of speech between the child and the parent | Up to 15 months |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Content analysis of guidance session by parent | Targeted interview of parents with the psychologist on the content of guidance session | At 16 months |
| Montreuil |
| 93100 |
| France |
| Hôpital Pitié Salpétriere | Paris | 75013 | France |
| Hôpital Necker Enfants Malades | Paris | 75015 | France |
| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D048788 | Growth and Development |
| ID | Term |
|---|---|
| D010829 | Physiological Phenomena |
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