- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT06691698
경도 지적 장애 청소년을 위한 CO-OP 평가 (CO-OPIF)
경도 지적 장애 청소년을 위한 일일 직업 수행(CO-OP) 접근에 대한 인지적 지향 평가
Intellectual disability (ID) affects a person throughout life and includes difficulties to manage what is expected in everyday life based on age. One difficulty is to create strategies for and solve problems related to everyday occupations. Treatment options with good evidence to enhance occupational performance for persons with ID are limited. The Cognitive Orientation to Daily Occupational Performance (CO-OP) is an approach with good evidence within other diagnostic groups, i.e. adolescents with cerebral palsy. CO-OP has a unique person-centered approach where the person chooses his/her own goals and creates his/her own strategies to reach them. Initial research shows potential for CO-OP with adolescents with ID, although due to scientific flaws there is still a lack of evidence regarding feasibility and effectiveness for adolescents with ID. Based on the results with other diagnostic groups and clinical knowledge and experience, CO-OP can be assumed to be feasible and effective for adolescents with ID and to have a long term effect transferred to everyday life in a way other treatment options do not.
The aim of the project is to describe and evaluate CO-OP for adolescents with mild ID. Participants will be adolescents aged 13-17 and their parents. The project is designed as a feasibility study with two qualitative, one quantitative and one mixed method data collection. The quantitative data will be ordinal and nominal data from observational and self-assessment assessments. The mixed methods include comparison between filmed sessions and the CO-OP manual, use of field notes to analyse fidelity and needs for adaptations, and comparison between the CO-OP manual and policy documents. The qualitative outcome will be experiences by the adolescents and perceptions of CO-OP by parents.
연구 개요
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Elin Widmark, MSc
- 전화번호: +46108319064
- 이메일: elin.widmark@oru.se
연구 연락처 백업
- 이름: Marie Holmefur, PhD
- 전화번호: +4619303612
- 이메일: marie.holmefur@oru.se
연구 장소
-
-
-
Örebro, 스웨덴, 65185
- 모병
- Region Örebro County
-
연락하다:
- Elin Widmark
- 전화번호: 0108319064
- 이메일: elin.widmark@oru.se
-
-
Skåne County
-
Kristianstad, Skåne County, 스웨덴, 29133
- 모병
- Region Skåne
-
연락하다:
- Elin Widmark, MSc, doctoral student
- 전화번호: +46108319064
- 이메일: elin.widmark@oru.se
-
-
Värmland County
-
Karlstad, Värmland County, 스웨덴, 65185
- 모병
- Region Värmland
-
연락하다:
- Elin Widmark, MSc, doctoral student
- 전화번호: +46108319064
- 이메일: elin.widmark@oru.se
-
부수사관:
- Elin Widmark, Doctoral student
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Study I-II
Inclusion criteria
- 13-17 years
- Diagnosed mild intellectual disability
- Motivation to reach self-selected goals
- Ability to identify those goals
- Possibility to meet once a week for ten weeks
- Access to a parent or significant other for support during intervention
Exclusion criteria:
- Movement related diagnosis (i.e. cerebral palsy or neuro muscular diseases)
- Diagnosed attention deficit hyperactivity disorder/attention deficit disorder (ADHD/ADD) or autism spectrum disorder
- Progressive diagnoses
- Need for language interpreting
- Need for alternative and augmentative communication (i.e. pictures or signs).
Study III
Inclusion criteria:
- 13-17 years
- Diagnosed mild intellectual disability
- Completed CO-OP intervention or at lest half way trough the intervention
- Opportunity to meet physically for an interview with in a month post and 6 months post intervention.
- CO-OP intervention done with high fidelity to CO-OP format with a CO-OP therapist that has written field notes, preferrably recruited from study I-II.
Exclusion criteria:
- Movement related diagnosis (i.e. cerebral palsy or neuro muscular diseases)
- Diagnosed attention deficit hyperactivity disorder/attention deficit disorder (ADHD/ADD) or autism spectrum disorder
- Progressive diagnoses
- Need for language interpreting
- Need for alternative and augmentative communication (i.e. pictures or signs).
Study IV
Inclusion criteria:
- Parents with legal guardianship that lives full- or part time with an adolescent reaching the inclusion criteria for study I who has completed CO-OP within or out of the project
- Opportunity to meet physically for an interview with in a month post and 6 months post the adolescent's completed, or at least half way through, CO-OP intervention.
Exclusion criteria:
- Need for language interpreting
- Need for alternative and augmentative communication (i.e. pictures or signs)
- Irregular and brief living with the adolescent comparable to less than half-time and therefore does not observe the adolescent's occupational performance enough to answer the interview questions.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: CO-OP for adolescents with mild intellectual disability
CO-OP intervention during 10 weeks. Outcomes measures at baseline, directly after and 6 months after intervention |
CO-OP is a client-centred, performance-based, problem-solving focused, occupation-focused and occupation-based intervention. In CO-OP the person is guided to use a meta-cognitive strategy to find his or her own strategies for specific activities. The main purpose is to enable meta-cognitive thinking in every day activities, leading to enhanced self-efficacy, occupational performance and independency.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in Canadian Occupational Performance Measure - performance
기간: Baseline, up to 4 weeks post intervention and 6 months post intervention
|
Self-rated occupational performance in four chosen goal activities, rated 1-10 |
Baseline, up to 4 weeks post intervention and 6 months post intervention
|
|
Change in Canadian Occupational Performance Measure - satisfaction
기간: Baseline, up to 4 weeks post intervention and 6 months post intervention
|
Self-rated satisfaction with performance in four chosen goal activities, rated 1-10 |
Baseline, up to 4 weeks post intervention and 6 months post intervention
|
|
Change in Performance Quality Rating Scale - occupational performance quality
기간: Baseline, up to 4 weeks post intervention and 6 months post intervention
|
Observed performance quality during performing four chosen goal activities thas is filmed and rated 1-10. |
Baseline, up to 4 weeks post intervention and 6 months post intervention
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in General Self-Efficacy Scale - self-efficacy
기간: Baseline, up to 4 weeks post intervention and 6 months post intervention
|
Self-rated self-efficacy, 10 statements rated 1-4. |
Baseline, up to 4 weeks post intervention and 6 months post intervention
|
|
Experiences of CO-OP as a patient - qualitative
기간: Up to 4 weeks post intervention and 6 months post intervention
|
Qualitative semi-structured interviews analyzed using qualitative content analysis. |
Up to 4 weeks post intervention and 6 months post intervention
|
|
Perceptions of CO-OP as a parent of a patient - qualitative
기간: Up to 4 weeks post intervention and 6 months post intervention
|
Qualitative semi-structured interviews analyzed using phenomenographic analysis |
Up to 4 weeks post intervention and 6 months post intervention
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Feasibility: Acceptability
기간: Up to 4 weeks post intervention and 6 months post intervention
|
Acceptability will be evaluated by structured interviews. The interview consists of five yes/no questions and a 10 point scale on how much effort the CO-OP intervention required. Data will be on nominal and ordinal level. |
Up to 4 weeks post intervention and 6 months post intervention
|
|
Feasibility: Possible expansion to a new group
기간: 2024-2025
|
Qualitative text analysis in which contents of the CO-OP manual will be compared with norms and values in the national policy documents for children and youth habilitation. This is carried out to evaluate whether it would be possible to expand this intervention to a new group of patients (adolescents with mild intellectual disability). The data collection is not related to the individual participants. |
2024-2025
|
|
Feasibility: Adaptation
기간: Up to 1 year after intervention.
|
Whether the CO-OP approach needs any adaptations in order to be feasible for adolescents with mild intellectual disability will be evaluated. This will be done by collecting field notes written by CO-OP therapists and a text analysis with descriptive comparison between notes and the CO-OP manual. |
Up to 1 year after intervention.
|
공동 작업자 및 조사자
협력자
수사관
- 수석 연구원: Marie Holmefur, PhD, Örebro University, Sweden
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
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
추가 관련 MeSH 약관
기타 연구 ID 번호
- ORU 2024-02873-01
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
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. .