- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03547843
The Effects of Peer Co-led Educational Group Intervention for Adults With Attention-Deficit Hyperactivity Disorder (ADHD)
The Effects of Peer Co-led Educational Group Intervention for Adults With Attention-Deficit Hyperactivity/Impulsivity Disorder
Peer co-led education describes educators who are expert patients, user representatives or former patients, participating and teaching in educational interventions in cooperation with health care professionals. Peer co-led education is included in the Norwegian national guidelines for treatment of mental disorders, but despite some promising results for the treatment of other conditions, still little is known about the efficacy of peer co-led educational group interventions interventions for adults with attention deficit and hyperactivity disorder (ADHD).
This pilot trial will evaluate patient satisfaction with and preliminary efficacy of a 2-session peer co-led educational group program designed to address specific challenges faced by adults diagnosed with ADHD at an outpatient clinics in mid-Norway.
연구 개요
상태
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Trondheim, 노르웨이, 7055
- Tiller DPS
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Confirmed ADHD-diagnosis
- speaking a Scandinavian language
Exclusion Criteria:
- Unable to give informed consent
- Psychosis
- Severe learning difficulties
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Educational intervention
Patients randomized to the intervention group will start with a group-based educational program immediately after the randomization.
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The group-based educational program consists of two sessions that run over two consecutive weeks.
Each session consists of a lecture from a recruited expert on the topic of the session and by expert patients with a following discussion of the topic facilitated by the course leader.
다른 이름들:
Diagnostic treatment with medication.
In addition, some patients receive cognitive behavioral therapy (not systematically given to every patient).
If needed, patients are also offered assistance with regard to economy, housing, education, and work as well as contact with family and network.
다른 이름들:
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활성 비교기: Waiting list
Participants randomized to the waiting list control group receive no educational intervention for the duration of the 10 weeks.
During this period participants can receive standard treatment, consisting of diagnostic treatment with medication.
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Diagnostic treatment with medication.
In addition, some patients receive cognitive behavioral therapy (not systematically given to every patient).
If needed, patients are also offered assistance with regard to economy, housing, education, and work as well as contact with family and network.
다른 이름들:
No educational intervention for the duration of the 10 weeks.
During this period participants can receive standard treatment.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in client Satisfaction
기간: from baseline to 2-weeks follow-up
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Client satisfaction will be measured with Client Satisfaction Questionnaire, short form (Attkisson & Zwick, 1982).
The scale consists of 8 items scored on a Likert scale from 1 (low satisfaction) to 4 (high satisfaction).
Total scores range from 8 to 32, with higher scores indicating greater satisfaction.
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from baseline to 2-weeks follow-up
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change in patient activation
기간: from baseline to 10-weeks follow-up
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Patient activation will be measured with the Norwegian version of the Patient Activation Measure Mental Health (PAM-MH) (Green et al 2010))
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from baseline to 10-weeks follow-up
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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change in general self-efficacy
기간: from baseline to 10 weeks follow-up
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General Self-Efficacy Scale, 6-item scale ranging from 1 ('not at all true') to 4 ('exactly true').
Total scores range from 6 to 24, with higher scores indicating greater self-efficacy.
(Romppel et al 2013)
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from baseline to 10 weeks follow-up
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change in ADHD-related symptoms
기간: from baseline to 10 weeks follow-up
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Hopkin's Symptom Checklist (SCL), 9-items scale with high scores on SCL-9 indicating ADHD-related symptom burden (Eich et al 2011)
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from baseline to 10 weeks follow-up
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change in ADHD-related symptoms
기간: from baseline to 10 weeks follow-up
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Norwegian version of the WHO Adult ADHD Self-report scale, ASRS Short Form (Kessler et al 2005)
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from baseline to 10 weeks follow-up
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change in Quality of Life
기간: from baseline to 10 weeks follow-up
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Adult Attention Deficit/Hyperactivity Disorder Quality of Life Scale, AAQoL short Form (Brod et al 2006)
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from baseline to 10 weeks follow-up
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Use of health services and work participation
기간: through study completion, an average of 24 weeks
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Self-reported work participation and received services: 3 questions about both work status and received treatment
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through study completion, an average of 24 weeks
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공동 작업자 및 조사자
수사관
- 연구 책임자: Anne-Lise Løvaas, md phd, St. Olavs Hospital
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 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. .