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ReclutandoNCT06691698Registro de ClinicalTrials.gov

Evaluation of CO-OP for Adolescents With Mild Intellectual Disability

Intellectual Disability, Mild

LO ESENCIAL

De qué trata este estudio

El registro indica que este estudio recluta participantes. La disponibilidad puede variar por centro.

Tipo de estudio
De intervención
Fase
No aplica
Rango de edad
13 años - 17 años
Sexo admitido
Todos los sexos
Voluntarios sanos
No aceptados
Participantes
60 Estimado

Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.

Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.

Acerca de la investigación

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.

¿Quién podría participar?

La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.

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.
Entiende la evaluación inicial

Tratamiento, grupos y participación

El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.

Asignación
No aplica
Enmascaramiento
Sin enmascaramiento
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

Other: The Cognitive Orientation to Daily Occupational Performance Approach

The Cognitive Orientation to Daily Occupational Performance Approach OTHER

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.

Prepara tus preguntas

Qué evalúan los investigadores

Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.

Medidas principales

Change in Canadian Occupational Performance Measure - performance

Plazo: Baseline, up to 4 weeks post intervention and 6 months post intervention

Self-rated occupational performance in four chosen goal activities, rated 1-10

Change in Canadian Occupational Performance Measure - satisfaction

Plazo: 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

Change in Performance Quality Rating Scale - occupational performance quality

Plazo: 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.

Medidas secundarias

Change in General Self-Efficacy Scale - self-efficacy

Plazo: Baseline, up to 4 weeks post intervention and 6 months post intervention

Self-rated self-efficacy, 10 statements rated 1-4.

Experiences of CO-OP as a patient - qualitative

Plazo: Up to 4 weeks post intervention and 6 months post intervention

Qualitative semi-structured interviews analyzed using qualitative content analysis.

Perceptions of CO-OP as a parent of a patient - qualitative

Plazo: Up to 4 weeks post intervention and 6 months post intervention

Qualitative semi-structured interviews analyzed using phenomenographic analysis

Otras medidas

Feasibility: Acceptability

Plazo: 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.

Feasibility: Possible expansion to a new group

Plazo: 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.

Feasibility: Adaptation

Plazo: 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.

El registro no indica resultados publicados.

Revisa las tablas completas y sus limitaciones en el registro oficial.

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Centros de investigación (3)

El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.

3 centros

Region SkåneKristianstad, Skåne County, SwedenReclutando
Elin Widmark, MSc, doctoral studentCONTACTelin.widmark@oru.se+46108319064
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Region VärmlandKarlstad, Värmland County, SwedenReclutando
Elin Widmark, MSc, doctoral studentCONTACTelin.widmark@oru.se+46108319064
Elin Widmark, Doctoral studentSUB_INVESTIGATOR
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Region Örebro CountyÖrebro, SwedenReclutando

Equipo y fechas

Patrocinador principal
Örebro University, Sweden
Inicio del estudio
16 ene 2025 Real
Finalización primaria
2027-12 Estimado
Finalización del estudio
2027-12 Estimado
Primera publicación
15 nov 2024 Real
Última actualización
10 nov 2026 Real

Contactos oficiales del estudio

Elin Widmark, MScCONTACTelin.widmark@oru.se+46108319064
Marie Holmefur, PhDCONTACTmarie.holmefur@oru.se+4619303612
Título oficial del estudio

Evaluation of The Cognitive Orientation to Daily Occupational Performance (CO-OP) Approach for Adolescents With Mild Intellectual Disability

EL PRÓXIMO PASO, CON APOYO HUMANO

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Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.

Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026