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临床试验/NCT04607616
NCT04607616进行中(未招募)不适用

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

Assistance Publique - Hôpitaux de Paris4 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2021年3月26日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
27
试验地点
4
主要终点
Percentage of time spent in a joint attention situation

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Months 至 3 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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)

研究组 & 干预措施

3 baselines sessions Treatment As Usual (TAU)

Experimental

Patients received 3 baseline sessions before interactive guidance therapy

干预措施: Baseline sessions TAU (Behavioral)

3 baselines sessions Treatment As Usual (TAU)

Experimental

Patients received 3 baseline sessions before interactive guidance therapy

干预措施: Developmental and diagnostic assessments (Diagnostic Test)

3 baselines sessions Treatment As Usual (TAU)

Experimental

Patients received 3 baseline sessions before interactive guidance therapy

干预措施: Interactive guidance therapy (Behavioral)

3 baselines sessions Treatment As Usual (TAU)

Experimental

Patients received 3 baseline sessions before interactive guidance therapy

干预措施: Developmental assessment -Parental scales (Behavioral)

3 baselines sessions Treatment As Usual (TAU)

Experimental

Patients received 3 baseline sessions before interactive guidance therapy

干预措施: Qualitative analysis (Behavioral)

4 baselines sessions TAU

Experimental

Patients received 4 baseline sessions before interactive guidance therapy

干预措施: Developmental assessment -Parental scales (Behavioral)

4 baselines sessions TAU

Experimental

Patients received 4 baseline sessions before interactive guidance therapy

干预措施: Baseline sessions TAU (Behavioral)

4 baselines sessions TAU

Experimental

Patients received 4 baseline sessions before interactive guidance therapy

干预措施: Interactive guidance therapy (Behavioral)

4 baselines sessions TAU

Experimental

Patients received 4 baseline sessions before interactive guidance therapy

干预措施: Developmental and diagnostic assessments (Diagnostic Test)

4 baselines sessions TAU

Experimental

Patients received 4 baseline sessions before interactive guidance therapy

干预措施: Qualitative analysis (Behavioral)

5 baselines sessions TAU

Experimental

Patients received 5 baseline sessions before interactive guidance therapy

干预措施: Developmental assessment -Parental scales (Behavioral)

5 baselines sessions TAU

Experimental

Patients received 5 baseline sessions before interactive guidance therapy

干预措施: Baseline sessions TAU (Behavioral)

5 baselines sessions TAU

Experimental

Patients received 5 baseline sessions before interactive guidance therapy

干预措施: Interactive guidance therapy (Behavioral)

5 baselines sessions TAU

Experimental

Patients received 5 baseline sessions before interactive guidance therapy

干预措施: Developmental and diagnostic assessments (Diagnostic Test)

5 baselines sessions TAU

Experimental

Patients received 5 baseline sessions before interactive guidance therapy

干预措施: Qualitative analysis (Behavioral)

6 baselines sessions TAU

Experimental

Patients received 6 baseline sessions before interactive guidance therapy

干预措施: Baseline sessions TAU (Behavioral)

6 baselines sessions TAU

Experimental

Patients received 6 baseline sessions before interactive guidance therapy

干预措施: Interactive guidance therapy (Behavioral)

6 baselines sessions TAU

Experimental

Patients received 6 baseline sessions before interactive guidance therapy

干预措施: Developmental and diagnostic assessments (Diagnostic Test)

6 baselines sessions TAU

Experimental

Patients received 6 baseline sessions before interactive guidance therapy

干预措施: Developmental assessment -Parental scales (Behavioral)

6 baselines sessions TAU

Experimental

Patients received 6 baseline sessions before interactive guidance therapy

干预措施: Qualitative analysis (Behavioral)

7 baselines sessions TAU

Experimental

Patients received 7 baseline sessions before interactive guidance therapy

干预措施: Baseline sessions TAU (Behavioral)

7 baselines sessions TAU

Experimental

Patients received 7 baseline sessions before interactive guidance therapy

干预措施: Interactive guidance therapy (Behavioral)

7 baselines sessions TAU

Experimental

Patients received 7 baseline sessions before interactive guidance therapy

干预措施: Developmental and diagnostic assessments (Diagnostic Test)

7 baselines sessions TAU

Experimental

Patients received 7 baseline sessions before interactive guidance therapy

干预措施: Developmental assessment -Parental scales (Behavioral)

7 baselines sessions TAU

Experimental

Patients received 7 baseline sessions before interactive guidance therapy

干预措施: Qualitative analysis (Behavioral)

8 baselines sessions TAU

Experimental

Patients received 8 baseline sessions before interactive guidance therapy

干预措施: Interactive guidance therapy (Behavioral)

8 baselines sessions TAU

Experimental

Patients received 8 baseline sessions before interactive guidance therapy

干预措施: Baseline sessions TAU (Behavioral)

8 baselines sessions TAU

Experimental

Patients received 8 baseline sessions before interactive guidance therapy

干预措施: Developmental and diagnostic assessments (Diagnostic Test)

8 baselines sessions TAU

Experimental

Patients received 8 baseline sessions before interactive guidance therapy

干预措施: Developmental assessment -Parental scales (Behavioral)

8 baselines sessions TAU

Experimental

Patients received 8 baseline sessions before interactive guidance therapy

干预措施: Qualitative analysis (Behavioral)

结局指标

主要结局

Percentage of time spent in a joint attention situation

时间窗: Up to 15 months

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

次要结局

  • Parent-child interactive features / Parental synchrony(Up to 15 months)
  • Change process(Up to 15 months)
  • Parent-child interactive features/ joint attention(Up to 15 months)
  • Parent-child interactive features / DCMA scale(Up to 15 months)
  • Parent-child interactive features / Communication(Up to 15 months)
  • Parent-child interactive features / Initiation of communication(Up to 15 months)
  • Child development / MSEL(Up to 15 months)
  • Child development / CDI(Up to 15 months)
  • Child development / IFDC(Up to 15 months)
  • Autistic Symptoms / CARS(Up to 15 months)
  • Autistic Symptoms ECAR(Up to 15 months)
  • Autistic Symptoms ADOS-2(Up to 15 months)
  • Content analysis of guidance session by parent(At 16 months)
  • Adaptive behavior of the child(Up to 15 months)
  • Autistic Symptoms ADIR(Up to 15 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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