Effectiveness of DIR/Floortime™ in Children With Intellectual Developmental Disorder (DIR-IDD)
Effectiveness of DIR/Floortime™ in Children With Intellectual Developmental Disorder: A Randomized Controlled Trial
연구 개요
상세 설명
Intellectual Developmental Disorder (IDD) is characterized by significant limitations in intellectual functioning and adaptive behavior, affecting conceptual, social, and practical skills. Although conventional therapeutic interventions support developmental progress, many children continue to experience challenges in communication, social interaction, daily living skills, and functional emotional development. The Developmental, Individual-differences, Relationship-based (DIR)/Floortime™ model is a relationship-based intervention designed to enhance emotional, social, and developmental capacities through child-led interactions.
This study is a parallel-group randomized controlled trial evaluating the effectiveness of Integrated DIR/Floortime™ in children with IDD. Participants aged 4-12 years will be randomly assigned to either an experimental group receiving DIR/Floortime™ in addition to standard therapy or a control group receiving standard therapy alone. The intervention will be delivered over a period of 10 weeks.
The primary outcomes include communication, socialization, daily living skills, and functional emotional development. These outcomes will be measured using the Vineland Adaptive Behavior Scales (VABS) and the Functional Emotional Assessment Scale (FEAS) at baseline and after completion of the 10-week intervention. The findings will contribute to the evidence regarding the effectiveness of DIR/Floortime™ for children with Intellectual Developmental Disorder.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
Punjab Province
-
Gujranwala, Punjab Province, 파키스탄
- SEND Therapy Center
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Children aged 4-12 years.
- Clinical diagnosis of Intellectual Developmental Disorder (IDD) according to DSM-5-TR criteria.
- Mild to moderate intellectual developmental impairment.
- Receiving routine therapeutic services.
- Able to participate in the 10-week DIR/Floortime™ intervention and study assessments.
- Written informed consent obtained from a parent or legal guardian.
Exclusion Criteria:
- Profound or severe Intellectual Developmental Disorder preventing meaningful participation in the intervention.
- Severe visual, hearing, or physical impairments that would interfere with assessments 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 written 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 |
|---|---|
|
실험적: DIR/Floortime + Standard Therapy
Participants receive Integrated DIR/Floortime™ in addition to their routine standard therapeutic services for 10 weeks.
|
Integrated Developmental, Individual-differences, Relationship-based (DIR)/Floortime™ intervention delivered for 10 weeks in addition to standard therapy
|
|
활성 비교기: Standard Therapy
Participants continue to receive routine standard therapeutic services without the addition of DIR/Floortime™ for 10 weeks.
|
Routine therapeutic services provided without DIR/Floortime™ during the 10-week study period.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Socialization Skills
기간: Baseline and Week 10
|
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.
|
Baseline and Week 10
|
|
Communication Skills
기간: Baseline and Week 10
|
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.
|
Baseline and Week 10
|
|
Daily Living Skills
기간: Baseline and Week 10
|
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.
|
Baseline and Week 10
|
|
Functional Emotional Development
기간: Baseline and Week 10
|
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.
|
Baseline and Week 10
|
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
추가 관련 MeSH 약관
기타 연구 ID 번호
- GIFT/PSY/MS/2025/001B
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
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .