- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT06691698
CO-OP:n arviointi lievästi kehitysvammaisille nuorille (CO-OPIF)
Kognitiivinen orientaatio päivittäiseen ammatilliseen suorituskykyyn (CO-OP) -lähestymistavan arviointi nuorille, joilla on lievä kehitysvamma
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.
Tutkimuksen yleiskatsaus
Tila
Interventio / Hoito
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Elin Widmark, MSc
- Puhelinnumero: +46108319064
- Sähköposti: elin.widmark@oru.se
Tutki yhteystietojen varmuuskopiointi
- Nimi: Marie Holmefur, PhD
- Puhelinnumero: +4619303612
- Sähköposti: marie.holmefur@oru.se
Opiskelupaikat
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Örebro, Ruotsi, 65185
- Rekrytointi
- Region Örebro County
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Ottaa yhteyttä:
- Elin Widmark
- Puhelinnumero: 0108319064
- Sähköposti: elin.widmark@oru.se
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Skåne County
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Kristianstad, Skåne County, Ruotsi, 29133
- Rekrytointi
- Region Skåne
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Ottaa yhteyttä:
- Elin Widmark, MSc, doctoral student
- Puhelinnumero: +46108319064
- Sähköposti: elin.widmark@oru.se
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Värmland County
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Karlstad, Värmland County, Ruotsi, 65185
- Rekrytointi
- Region Värmland
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Ottaa yhteyttä:
- Elin Widmark, MSc, doctoral student
- Puhelinnumero: +46108319064
- Sähköposti: elin.widmark@oru.se
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Alatutkija:
- Elin Widmark, Doctoral student
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
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.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Ei käytössä
- Inventiomalli: Yksittäinen ryhmätehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
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Kokeellinen: 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.
Muut nimet:
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Change in Canadian Occupational Performance Measure - performance
Aikaikkuna: Baseline, up to 4 weeks post intervention and 6 months post intervention
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Self-rated occupational performance in four chosen goal activities, rated 1-10 |
Baseline, up to 4 weeks post intervention and 6 months post intervention
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Change in Canadian Occupational Performance Measure - satisfaction
Aikaikkuna: Baseline, up to 4 weeks post intervention and 6 months post intervention
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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
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Change in Performance Quality Rating Scale - occupational performance quality
Aikaikkuna: Baseline, up to 4 weeks post intervention and 6 months post intervention
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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
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Change in General Self-Efficacy Scale - self-efficacy
Aikaikkuna: Baseline, up to 4 weeks post intervention and 6 months post intervention
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Self-rated self-efficacy, 10 statements rated 1-4. |
Baseline, up to 4 weeks post intervention and 6 months post intervention
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Experiences of CO-OP as a patient - qualitative
Aikaikkuna: Up to 4 weeks post intervention and 6 months post intervention
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Qualitative semi-structured interviews analyzed using qualitative content analysis. |
Up to 4 weeks post intervention and 6 months post intervention
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Perceptions of CO-OP as a parent of a patient - qualitative
Aikaikkuna: Up to 4 weeks post intervention and 6 months post intervention
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Qualitative semi-structured interviews analyzed using phenomenographic analysis |
Up to 4 weeks post intervention and 6 months post intervention
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Muut tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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Feasibility: Acceptability
Aikaikkuna: Up to 4 weeks post intervention and 6 months post intervention
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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
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Feasibility: Possible expansion to a new group
Aikaikkuna: 2024-2025
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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
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Feasibility: Adaptation
Aikaikkuna: Up to 1 year after intervention.
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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.
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Yhteistyökumppanit ja tutkijat
Sponsori
Yhteistyökumppanit
Tutkijat
- Päätutkija: Marie Holmefur, PhD, Örebro University, Sweden
Julkaisuja ja hyödyllisiä linkkejä
Hyödyllisiä linkkejä
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
- Neurologiset ilmenemismuodot
- Hermoston sairaudet
- Mielenterveyshäiriöt
- Neoplasmat
- Immuunijärjestelmän sairaudet
- Neoplasmat histologisen tyypin mukaan
- Neurokäyttäytymisoireet
- Lymfaattiset sairaudet
- Lymfoproliferatiiviset häiriöt
- Immunoproliferatiiviset häiriöt
- Lymfooma, non-Hodgkin
- Neurokehityshäiriöt
- Lymfooma
- Patologiset tilat, merkit ja oireet
- Merkit ja oireet
- Hemic- ja imusuutteet
- Lymfooma, follikulaarinen
- Henkinen vamma
Muut tutkimustunnusnumerot
- ORU 2024-02873-01
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