- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07836972
Novel Approaches to Supporting Students With ADHD in Multi-Tiered Systems of Support
Novel Approaches to Supporting Students With ADHD in Multi-Tiered Systems of Support (MTSS)
Children with attention-deficit/hyperactivity disorder (ADHD) are likely to exhibit behavioral difficulties in the classroom that inhibit learning (Daley & Birchwood, 2010; DuPaul & Stoner, 2003; Fabiano et al., 2006; Friedman & Pfiffner, 2020; Loe & Feldman, 2007; Raggi & Chronis, 2006; Rapport, Chung, Shore, & Isaacs, 2001). These issues make addressing ADHD an area in need of continuous and contemporary support, particularly during early elementary school (Bitsko et al., 2022), in order to prevent the worsening, life-long issues that individuals with ADHD may confront throughout the lifespan. The present application focuses on supports and interventions for students in elementary school, as that is where initial identification and intervention typically occurs (Visser et al., 2014). With the advent of Multi-Tiered Systems of Support (MTSS) within school settings, a systematic approach to the delivery of universal, targeted, and indicated school mental health and educational supports may be enhanced. The most intensive tier of the MTSS (i.e., Tier 3) is currently the most under-developed. The creation of a positive behavioral support classroom through Tier 3 of the MTSS will assist teachers in improving the positive behavioral support provided to the student with ADHD. Thus, the present investigation will be situated within everyday school procedures for supporting a student with behaviors consistent with ADHD. Participants will be 288 elementary school children recruited from participating school districts within the existing school-based problem solving teams. We will work with grades kindergarten to sixth. Referred children will then all receive a lead-in, Tier 2 intervention to include a daily report card (DRC) intervention. Those who continue to need additional behavior supports in the Spring -- Tier 3 intervention -- will be allocated through random assignment to School as Usual or Academic/Behavior Competency (ACE) classroom in a Hybrid Type 1 design. The ACE classroom is an approach based on decades of research in summer treatment program classrooms (Fabiano et al., 2007; Pelham et al., 2025). Aim 1 evaluates the outcomes of the approach relative to school as usual. Aim 2 evaluates the implementation of the approach and explores components of user implementation that promote fidelity. Aim 3 explores moderators of the intervention outcomes (e.g., comorbid oppositional/aggressive behavior or learning disabilities).
연구 개요
상태
연구 유형
등록 (추정된)
단계
- 2 단계
- 3단계
연락처 및 위치
연구 연락처
- 이름: Gregory A. Fabiano, Ph.D.
- 전화번호: 716-359-7823
- 이메일: gfabiano@fiu.edu
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Elevated ADHD symptoms and impairment and referred to school-based support team for intervention.
- Attending grades kindergarten - fifth
Exclusion Criteria:
- Special education classification for academics or behavior
- Behavior concerns at a level that would make lead-in treatment inappropriate/of insufficient intensity
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: School as Usual
Lead-in Intervention followed by Assignment to School as Usual |
This arm will include school as usual procedures for students. |
|
실험적: Academic Competency Enhancement (ACE) classroom
Lead-in Intervention followed by Assignment to Academic Competency Enhancement (ACE) classroom |
Children assigned to ACE will enroll in a classroom with a teacher trained to implement contingency management components throughout the school year. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Count of Child rule violations
기간: Baseline, End of School year 1, Beginning of School year 2, Middle of School year 2, End of School year 2
|
Observation of frequency of rule violations |
Baseline, End of School year 1, Beginning of School year 2, Middle of School year 2, End of School year 2
|
|
IOWA Connors Rating Scale
기간: Baseline, End of School year 1, Beginning of School year 2, Middle of School year 2, End of School year 2
|
Total Score on Inattentive/Overactive Factor |
Baseline, End of School year 1, Beginning of School year 2, Middle of School year 2, End of School year 2
|
|
Impairment Rating Scale
기간: Baseline, End of School year 1, Beginning of School year 2, Middle of School year 2, End of School year 2
|
Baseline, End of School year 1, Beginning of School year 2, Middle of School year 2, End of School year 2
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Gregory A. Fabiano, Ph.D., Florida International University
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
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
- R01MH144202 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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