- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00760812
Comparing Parent-Implemented Interventions for Toddlers With Autism Spectrum Disorders
Effects of Parent-Implemented Intervention for Toddlers With Autism Spectrum (The ESI Study)
연구 개요
상태
정황
상세 설명
Autism is a problem with normal social development and is characterized by impairments in three categories: social skills, language, and behavior. Symptoms include disinterest or inability to have normal social relationships, abnormal speech or usage of phrases, and repetitive movements or rituals; these symptoms generally emerge by 18 months of age. Autism is a spectrum disorder, meaning that its symptoms can range in severity from mild to severe. There is no cure for autism, nor is there a single known cause. There are only factors known to make it more likely for children to develop autism. These include being a male, having siblings with the disorder, having certain other disorders, or having an older father. Treatments for autism generally include therapies that help children develop social communication skills and that help structure family time and school so that parents and teachers can address particular difficulties children with autism might have. Medications may also be used to counteract anxieties or compulsive behaviors.
Research has shown that earlier interventions in children who are at risk of autism may lead to better outcomes. This study will compare two interventions for developing social communication skills in children who are at risk of autism and are between 16 and 20 months old. The parent-implemented intervention (PII) will be a more intense, individualized approach, teaching parents to embed 25 hours of social communication skills practice per week in their children's daily lives. The information, education, and support (IES) intervention will offer parents a support group and place to practice methods of helping their children learn adaptive social communication.
Participation in this study will last 18 months. Participants will be randomly assigned to first receive 9 months of either PII or IES and then receive 9 months of whichever intervention they did not receive initially. The PII intervention will involve three weekly sessions for 7 months, then two weekly sessions for 2 months. The IES intervention will involve group meetings twice monthly and offer a playground where parents can practice intervention strategies with their children. All parents will complete questionnaires about family resources and social and emotional issues before the first intervention begins, after 9 months when the intervention changes, and after 18 months when the second intervention ends. Children and parents will also be assessed once a month throughout the study on social communication, autism symptoms, developmental level, and hours spent on learned strategies or techniques outside the study visits. These assessments will involve clinical assessments of parent and child behaviors (some of which will be videotaped), tests of children's abilities, and reports by parents on strategies and techniques used outside the clinic.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Florida
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Tallahassee, Florida, 미국, 32306
- Florida State University
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Michigan
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Ann Arbor, Michigan, 미국, 48109
- University of Michigan
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Presence of autism risk factors and a clinical diagnosis of autism spectrum disorder based on a diagnostic evaluation conducted by the project team
- Families agree to twice monthly play group sessions for 9 months and two to three intervention sessions per week for 9 months, usually to be scheduled within workday hours
- Families agree to monthly evaluations, videotaping of intervention sessions, and weekly or monthly video checks during the 18 months of treatment
Exclusion Criteria:
- Child does not have normal hearing or adequate motor control to make simple actions, such as giving and reaching gestures
- Primary language of family is not English
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: ESI--Individual PII First Condition
This group will first receive the Early Social Interaction (ESI) model individual parent-implemented intervention (PII) for 9 months, followed by the ESI model group information, education, and support (IES) intervention for 9 months.
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The PII is an intensive, individualized treatment that teaches parents how to support social communication skills in children with autism by embedding skills practice within everyday routines, activities, and places.
Participants will have three 75-minute sessions weekly with study administrators for the first 7 months of the study.
Participants will then have two sessions per week for the final 2 months of the study.
Children will also practice socialization embedded in normal activities for 25 hours a week outside of study visits.
The IES intervention provides access to a support group meeting twice monthly for children with autism and their parents.
The support group provides information to families and a playgroup where parents may practice intervention strategies under the supervision of study officials knowledgeable about autism spectrum disorders.
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실험적: ESI--Group IES First Condition
The group will first receive ESI group IES condition for 9 months, followed by ESI individual PII for 9 months.
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The PII is an intensive, individualized treatment that teaches parents how to support social communication skills in children with autism by embedding skills practice within everyday routines, activities, and places.
Participants will have three 75-minute sessions weekly with study administrators for the first 7 months of the study.
Participants will then have two sessions per week for the final 2 months of the study.
Children will also practice socialization embedded in normal activities for 25 hours a week outside of study visits.
The IES intervention provides access to a support group meeting twice monthly for children with autism and their parents.
The support group provides information to families and a playgroup where parents may practice intervention strategies under the supervision of study officials knowledgeable about autism spectrum disorders.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Child measures of autism symptoms, social communication, developmental level, and adaptive behavior
기간: Measured before treatment, at crossover, and after treatment; some of these measures also will be taken every other month
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Measured before treatment, at crossover, and after treatment; some of these measures also will be taken every other month
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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Parent report measures of family functioning, daily hassles, and treatment satisfaction
기간: Measured before treatment, at crossover, and after treatment
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Measured before treatment, at crossover, and after treatment
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공동 작업자 및 조사자
수사관
- 수석 연구원: Amy M. Wetherby, PhD, Florida State University
- 수석 연구원: Catherine Lord, PhD, University of Michigan
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- R01MH077730 (미국 NIH 보조금/계약)
- DDTR B2-MBA (기타 보조금/기금 번호: National Institute of Mental Health)
- 1R01MH077730-01A2 (미국 NIH 보조금/계약)
- 1R01MH078165-01A2 (미국 NIH 보조금/계약)
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