- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT06691698
Evaluering af CO-OP for unge med let udviklingshæmning (CO-OPIF)
Evaluering af den kognitive orientering til daglige arbejdspræstationer (CO-OP) tilgang for unge med let intellektuelt handicap
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Elin Widmark, MSc
- Telefonnummer: +46108319064
- E-mail: elin.widmark@oru.se
Undersøgelse Kontakt Backup
- Navn: Marie Holmefur, PhD
- Telefonnummer: +4619303612
- E-mail: marie.holmefur@oru.se
Studiesteder
-
-
-
Örebro, Sverige, 65185
- Rekruttering
- Region Örebro County
-
Kontakt:
- Elin Widmark
- Telefonnummer: 0108319064
- E-mail: elin.widmark@oru.se
-
-
Skåne County
-
Kristianstad, Skåne County, Sverige, 29133
- Rekruttering
- Region Skåne
-
Kontakt:
- Elin Widmark, MSc, doctoral student
- Telefonnummer: +46108319064
- E-mail: elin.widmark@oru.se
-
-
Värmland County
-
Karlstad, Värmland County, Sverige, 65185
- Rekruttering
- Region Värmland
-
Kontakt:
- Elin Widmark, MSc, doctoral student
- Telefonnummer: +46108319064
- E-mail: elin.widmark@oru.se
-
Underforsker:
- Elin Widmark, Doctoral student
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Canadian Occupational Performance Measure - performance
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in General Self-Efficacy Scale - self-efficacy
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Feasibility: Acceptability
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Marie Holmefur, PhD, Örebro University, Sweden
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Neurologiske manifestationer
- Sygdomme i nervesystemet
- Psykiske lidelser
- Neoplasmer
- Sygdomme i immunsystemet
- Neoplasmer efter histologisk type
- Neuroadfærdsmæssige manifestationer
- Lymfesygdomme
- Lymfoproliferative lidelser
- Immunproliferative lidelser
- Lymfom, Non-Hodgkin
- Neuroudviklingsforstyrrelser
- Lymfom
- Patologiske tilstande, tegn og symptomer
- Tegn og symptomer
- Hemiske og lymfatiske sygdomme
- Lymfom, follikulært
- Intellektuel handicap
Andre undersøgelses-id-numre
- ORU 2024-02873-01
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .