Effectiveness of DIR/Floortime™ in Children With Autism Spectrum Disorder (DIR-ASD)
Efficacy of Integrated DIR/Floortime™ for Children With Autism Spectrum Disorder: A Randomized Controlled Trial
연구 개요
상세 설명
Autism Spectrum Disorder (ASD) is a neurodevelopmental condition that significantly affect emotional development, communication, and social interaction. Although conventional interventions target specific developmental domains, many children continue to experience challenges in functional emotional capacities and daily living skills.
Developmental, Individual-differences, Relationship-based (DIR)/Floortime™ is a relationship-based intervention that promotes emotional regulation, communication, social engagement, and higher-order thinking through child-led, developmentally appropriate interactions. This study investigates the effectiveness of integrating DIR/Floortime™ with standard therapeutic services.
This study uses a parallel-group randomized controlled design. Eligible children aged 4-12 years diagnosed with ASD are randomly assigned to either an intervention group receiving DIR/Floortime™ plus standard therapies or a control group receiving standard therapies alone. Outcomes are measured before and after the intervention using the Functional Emotional Assessment Scale (FEAS) and the Vineland Adaptive Behavior Scales (VABS). The findings are expected to contribute evidence regarding the effectiveness of DIR/Floortime™ in improving functional emotional development and adaptive behavior among children with ASD and IDD.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Punjab Province
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Gujranwala, Punjab Province, 파키스탄
- SEND Therapy Center
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Children aged 4-12 years.
- Clinical diagnosis of Autism Spectrum Disorder (ASD) according to DSM-5-TR criteria according to DSM-5-TR criteria.
- Mild to moderate ASD severity.
- Receiving routine therapeutic services.
- Eligible to participate in the 10-week DIR/Floortime™ intervention.
- Parent or legal guardian willing to provide written informed consent.
Exclusion Criteria:
- Severe Autism Spectrum Disorder that would prevent participation in the intervention.
- Severe visual, hearing, or physical impairments interfering with assessment or intervention.
- Major neurological or genetic disorders that could affect study participation.
- Serious medical or psychiatric conditions requiring intensive treatment.
- Participation in another intervention study during the study period.
- Parent or legal guardian unwilling to provide informed consent.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: DIR/Floortime + Standard Therapy
Participants received Integrated DIR/Floortime™ in addition to their ongoing standard therapies.
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Participants received Integrated DIR/Floortime™ intervention for 10 weeks in addition to their ongoing standard therapies.
The intervention focused on promoting functional emotional development, communication, social interaction, and adaptive functioning through child-led, relationship-based sessions conducted according to the DIR/Floortime™ model.
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활성 비교기: Standard Therapy
Participants continued to receive standard therapies without DIR/Floortime
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Participants continued to receive routine standard therapeutic services without the addition of DIR/Floortime™ during the 10-week study period.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Socialization Skills
기간: Baseline and Week 10
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Change in Socialization Skills measured using the Vineland Adaptive Behavior Scales, Third Edition (VABS-3), Socialization domain Growth Scale Values (GSVs).
GSVs range from 10 to 197, with higher scores indicating better adaptive functioning.
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Baseline and Week 10
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Communication Skills
기간: Baseline and Week 10
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Change in Communication Skills measured using the Vineland Adaptive Behavior Scales, Third Edition (VABS-3), Communication domain Growth Scale Values (GSVs).
GSVs range from 10 to 197, with higher scores indicating better adaptive functioning.
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Baseline and Week 10
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Daily Living Skills
기간: Baseline and Week 10
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Change in Daily Living Skills measured using the Vineland Adaptive Behavior Scales, Third Edition (VABS-3), Daily Living Skills domain Growth Scale Values (GSVs).
GSVs range from 10 to 197, with higher scores indicating better adaptive functioning.
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Baseline and Week 10
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Functional Emotional Development
기간: Baseline and Week 10
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Change in functional emotional development measured using the Functional Emotional Assessment Scale (FEAS).
FEAS items are scored from 0 to 2, with higher scores indicating better functional emotional development.
Symbolic, Sensory, and Examiner scores are assessed.
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Baseline and Week 10
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공동 작업자 및 조사자
스폰서
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
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
- GIFT/PSY/MS/2025/001
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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