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Evaluation of CO-OP for Adolescents With Mild Intellectual Disability

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 13 Years - 17 Years
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT06691698
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Örebro University, Sweden
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Marie Holmefur, PhD
Principal Investigator Affiliation Örebro University, Sweden
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries Sweden
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Intellectual Disability, Mild
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: 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

Interventions

Other: - 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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Region Skåne, Kristianstad 2699310, Skåne County 3337385, Sweden

Status

Recruiting

Address

Region Skåne

Kristianstad 2699310, Skåne County 3337385, 29133

Site Contact

Elin Widmark, MSc, doctoral student

[email protected]

+46108319064

Region Värmland, Karlstad 2701680, Värmland County 2664870, Sweden

Status

Recruiting

Address

Region Värmland

Karlstad 2701680, Värmland County 2664870, 65185

Site Contact

Elin Widmark, MSc, doctoral student

[email protected]

+46108319064

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