Efficacy of the Apollo System for Children With ADHD
Double-blind Randomized Placebo-controlled Trial of the Efficacy of the Apollo System for Children With ADHD
연구 개요
상세 설명
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Matthew B Pontifex, PhD
- 전화번호: 517-432-5105
- 이메일: pontifex@msu.edu
연구 장소
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Michigan
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East Lansing, Michigan, 미국, 48824
- 모병
- Department of Kinesiology
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연락하다:
- Matthew B Pontifex, Ph.D.
- 전화번호: 517-432-5105
- 이메일: pontifex@msu.edu
-
수석 연구원:
- Matthew B Pontifex, Ph.D.
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria: All individuals that agreed to participate will be selected on a first come, first serve basis. No individual will be turned down due to sex, race, or ethnicity. The following inclusion criteria exist for all participants:
- Participants must be 8 years of age or older and under the age of 18.
- Participants must have diagnosed or suspected Attention Deficit Hyperactivity Disorder (ADHD).
- Participants must have one of the following: 1) on the same treatment plan for over a year with minimal symptom relieve or alleviation, 2) tried two or more treatment approaches but is unable to meet treatment goals, 3) taking medication but still has symptoms, or 4) unwanted or uncontrollable side effects related to the medication.
- Participants must have normal or corrected-to-normal vision in order to complete the cognitive task.
Exclusion Criteria: The following exclusion criteria exist for all participants:
- Lack of consent.
- Participants cannot have started a new treatment within the last 30 days.
- Participants cannot have a history of hydrocephalus, Autism Spectrum Disorder, Schizophrenia, Conduct disorder, Oppositional Defiant Disorder, active substance abuse, or be on a beta blocker.
- Participants cannot have previously used the Apollo System.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Commercial Apollo System Device
The active experimental group received the commercial Apollo System device.
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Use of the devices for an 8 week study period.
Devices are preset to follow a scheduled activation pattern during the day.
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가짜 비교기: Sham Apollo System Device
The control experimental group received a sham/placebo device that is identical to the commercial Apollo System device but uses an ultra-low (i.e., effectively zero) frequency pattern of vibrations.
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Use of the devices for an 8 week study period.
Devices are preset to follow a scheduled activation pattern during the day.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in ADHD symptomatology as assessed using the ADHD-5 Rating Scale
기간: Prior to and following the 8 week study protocol period.
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At pre and posttest, the parents/guardians of participants will complete the ADHD-5 Rating Scale.
The behaviors included in the survey are derived from the diagnostic criteria for ADHD established in the Diagnostic and Statistical Manual of Mental Disorders, 5th edition.
Scores are summated into inattentive and hyperactive-impulsive symptom domains and transformed into symptom percentile scores based upon normative data based on age and biological sex.
Change in the overall ADHD percentile will be considered as the primary outcome.
A more negative change would indicate a better outcome reflective of reduction in ADHD related symptomatology.
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Prior to and following the 8 week study protocol period.
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Effect Size for Change in Behavioral Index of Interference Control
기간: Prior to and following the 8 week study protocol period.
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At pre and posttest, participants will complete a version of the Eriksen flanker task. Response accuracy will be quantified within each congruency as the proportion of correct responses relative to the number of trials administered. The effect size of the change from pre-to-posttest in overall response accuracy will be considered as the primary outcome. Effect sizes will be computed per Arm and do not reflect comparisons or combinations across Arms/Groups using the repeated measures variance correction for Cohen's d (Lakens, 2013). |
Prior to and following the 8 week study protocol period.
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Effect Size for Change in Behavioral Index of Response Inhibition
기간: Prior to and following the 8 week study protocol period.
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At pre and posttest, participants will complete a version of the go/nogo task. Response accuracy will be quantified as the proportion of correct responses relative to the number of trials administered for target stimulus trails and nogo stimulus trials separately. The effect size of the change from pre-to-posttest for response accuracy to the nogo condition will be considered as the primary outcome. Effect sizes will be computed per Arm and do not reflect comparisons or combinations across Arms/Groups using the repeated measures variance correction for Cohen's d (Lakens, 2013). |
Prior to and following the 8 week study protocol period.
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공동 작업자 및 조사자
수사관
- 수석 연구원: Matthew B Pontifex, PhD., Michigan State University
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
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
- STUDY00005951
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 기간
IPD 공유 액세스 기준
IPD 공유 지원 정보 유형
- 연구 프로토콜
- 통계 분석 계획(SAP)
- 정보에 입각한 동의서(ICF)
- 분석 코드
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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