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Évaluation de la coopérative pour les adolescents ayant une déficience intellectuelle légère (CO-OPIF)

5 novembre 2026 mis à jour par: Marie Holmefur, Örebro University, Sweden

Évaluation de l'approche d'orientation cognitive vers la performance professionnelle quotidienne (CO-OP) pour les adolescents ayant une déficience intellectuelle légère

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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

60

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Lieux d'étude

  • Suède
      • Örebro, Suède, 65185
        • Recrutement
        • Region Örebro County
        • Contact:
    • Skåne County
      • Kristianstad, Skåne County, Suède, 29133
        • Recrutement
        • Region Skåne
        • Contact:
          • Elin Widmark, MSc, doctoral student
          • Numéro de téléphone: +46108319064
          • E-mail: elin.widmark@oru.se
    • Värmland County
      • Karlstad, Värmland County, Suède, 65185
        • Recrutement
        • Region Värmland
        • Contact:
          • Elin Widmark, MSc, doctoral student
          • Numéro de téléphone: +46108319064
          • E-mail: elin.widmark@oru.se
        • Sous-enquêteur:
          • Elin Widmark, Doctoral student

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

13 ans à 17 ans (Enfant)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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
Autre: The Cognitive Orientation to Daily Occupational Performance Approach

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.

Autres noms:
  • COOPÉRATIVE

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in Canadian Occupational Performance Measure - performance
Délai: 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
Délai: 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
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change in General Self-Efficacy Scale - self-efficacy
Délai: 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
Délai: 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
Délai: 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

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Feasibility: Acceptability
Délai: 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
Délai: 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
Délai: 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.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Örebro University, Sweden

Collaborateurs

Göteborg University
Stiftelsen Sunnerdahls Handikappfond
Landstinget i Värmland
Stiftelsen Sävstaholm
Majblommans riksförbund

Les enquêteurs

  • Chercheur principal: Marie Holmefur, PhD, Örebro University, Sweden

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Liens utiles

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

16 janvier 2025

Achèvement primaire (Estimé)

1 décembre 2027

Achèvement de l'étude (Estimé)

1 décembre 2027

Dates d'inscription aux études

Première soumission

5 novembre 2024

Première soumission répondant aux critères de contrôle qualité

14 novembre 2024

Première publication (Réel)

15 novembre 2024

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

10 novembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

5 novembre 2026

Dernière vérification

1 novembre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • ORU 2024-02873-01

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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