- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00004449
Randomized Study of Intensive One-on-one Behavioral Treatment for Preschool Aged Children With Autism
Randomized Study of Intensive One-on-one Behavioral Treatment Versus Individualized Parent Training in Preschool Aged Children With Autism
OBJECTIVES: I. Determine the effectiveness of intensive one-on-one behavioral treatment in the home or neighborhood compared with at home, individualized, parent training in preschool aged children with autism.
II. Identify intake measures that predict differences in outcome between subjects in the experimental group.
연구 개요
상태
정황
상세 설명
PROTOCOL OUTLINE: This is a randomized study. Children are randomized to receive either 35 hours of intensive one-on-one behavioral treatment in the home and neighborhood for 2 years or individualized, in home parent training for 6 months.
A common group of tests to evaluate autism are administered at intake, 12 and 24 months into treatment, and when patients reach age 6.
연구 유형
등록 (실제)
단계
- 해당 없음
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
INCLUSION CRITERIA:
--Disease Characteristics--
Diagnosis of autism based on the Autism Diagnostic Interview using the ICD-10 research criteria
Ratio IQ score greater than 35 determined from the Bayley Scales of Infant Development
--Patient Characteristics--
Other:
Must reside within 60 km (37.5 miles) of a treatment site
EXCLUSION CRITERIA:
Severe medically induced limitations defined as:
- Any condition requiring prosthetic devices (e.g., blindness, deafness, or cerebral palsy)
- Any illness that has prevented or would prevent a subject from participating in 30 hours a week of treatment for six consecutive weeks or more (e.g., metastasized cancer or end stage renal disease)
- Any known genetic disorder (e.g., Fragile X, PKU, or Down Syndrome)
- Any other disorder that rules out autism according to ICD-10 criteria (e.g., Rett's Syndrome)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Wechsler Preschool and Primary Scales of Intelligence, 3rd ed.
기간: yearly for up to 4 years
|
IQ
|
yearly for up to 4 years
|
|
Bayley Scales of Infant Development
기간: yearly for up to 4 years
|
Alternate cognitive test administered to participants who did not achieve basal on WPPSI-III
|
yearly for up to 4 years
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Merrill-Palmer Scale of Mental Tests
기간: yearly for up to 4 years
|
Nonverbal cognitive skills
|
yearly for up to 4 years
|
|
Reynell Developmental Language Scales
기간: yearly for up to 4 years
|
Language comprehension and expressive language
|
yearly for up to 4 years
|
|
Vineland Adaptive Behavior Scales - Survey Edition
기간: yearly for up to 4 years
|
Parent interview on child's adaptive functioning
|
yearly for up to 4 years
|
공동 작업자 및 조사자
수사관
- 연구 책임자: Tristram Smith, Ph.D., University of Rochester
간행물 및 유용한 링크
일반 간행물
- Cohen H, Amerine-Dickens M, Smith T. Early intensive behavioral treatment: replication of the UCLA model in a community setting. J Dev Behav Pediatr. 2006 Apr;27(2 Suppl):S145-55. doi: 10.1097/00004703-200604002-00013.
- Sallows GO, Graupner TD. Intensive behavioral treatment for children with autism: four-year outcome and predictors. Am J Ment Retard. 2005 Nov;110(6):417-38. doi: 10.1352/0895-8017(2005)110[417:IBTFCW]2.0.CO;2.
- Hayward D, Eikeseth S, Gale C, Morgan S. Assessing progress during treatment for young children with autism receiving intensive behavioural interventions. Autism. 2009 Nov;13(6):613-33. doi: 10.1177/1362361309340029.
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 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- R01MH048863 (미국 NIH 보조금/계약)
- UCLA-HSPC-G930506611
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