軽度知的障害のある青少年のための生協の評価 (CO-OPIF)
軽度知的障害のある青少年に対する日常の職業パフォーマンスに対する認知的指向(CO-OP)アプローチの評価
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.
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前:Elin Widmark, MSc
- 電話番号:+46108319064
- メール:elin.widmark@oru.se
研究連絡先のバックアップ
- 名前:Marie Holmefur, PhD
- 電話番号:+4619303612
- メール:marie.holmefur@oru.se
研究場所
-
-
-
Örebro、スウェーデン、65185
- 募集
- Region Örebro County
-
コンタクト:
- Elin Widmark
- 電話番号:0108319064
- メール:elin.widmark@oru.se
-
-
Skåne County
-
Kristianstad、Skåne County、スウェーデン、29133
- 募集
- Region Skåne
-
コンタクト:
- Elin Widmark, MSc, doctoral student
- 電話番号:+46108319064
- メール:elin.widmark@oru.se
-
-
Värmland County
-
Karlstad、Värmland County、スウェーデン、65185
- 募集
- Region Värmland
-
コンタクト:
- Elin Widmark, MSc, doctoral student
- 電話番号:+46108319064
- メール:elin.widmark@oru.se
-
副調査官:
- Elin Widmark, Doctoral student
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:なし
- 介入モデル:単一グループの割り当て
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的: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.
他の名前:
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Canadian Occupational Performance Measure - performance
時間枠: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
時間枠: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
時間枠: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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in General Self-Efficacy Scale - self-efficacy
時間枠: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
時間枠: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
時間枠: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
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Feasibility: Acceptability
時間枠: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
時間枠: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
時間枠: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.
|
協力者と研究者
協力者
捜査官
- 主任研究者:Marie Holmefur, PhD、Örebro University, Sweden
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- ORU 2024-02873-01
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。