- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02160886
Effects of a Task Oriented Intervention With Two Goal-setting Approaches
Effects of a Task Oriented Intervention for Children With Disabilities, Based on Children's or Parent's Goals, a Randomized Study.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Gävle, Sweden, 806 33
- Gävleborg County Council
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- enrollment in pediatric rehabilitation, age between 5-12 years and any type of disability but functioning at or above a 5 year old level in receptive language.
Exclusion Criteria:
- involvement in another block of intensive intervention during the 5-month study period
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Child-goal
The children will receive goal- directed task oriented interventions based on goals identified by the children themselves, using the Swedish version of the Perceived Efficacy and Goal Setting System (PEGS). A PEGS interview will be performed with the children. The children identifies tasks they find difficult to perform and prioritize three tasks, they want to perform better, as goals for intervention. |
The 8-week goal-directed intervention include completing a daily home program and a weekly follow-up session with the child's occupational therapist. The parents are responsible for the day to day practice and are encouraged to let the children practice daily in their natural environment. The home-programs focus on enhancing the agreed upon goal specific task performance. They include structured practice of tasks and adaptations and modifications of the environment and the tasks. The weekly sessions with the occupational therapist are meant to sustain motivation, follow-up on progress, adjust the home program for the coming week and support parents in how to carry out the daily interventions. |
Experimental: Parent-goal
The children will receive goal- directed task oriented interventions based on goals identified by the parents using the Canadian Occupational Performance Measure (COPM). Using the COPM interview technique, the parents are encouraged to talk about an ordinary day to identify occupational performance issues their child is not able to perform. Identified performance issues are rated for importance and the parents selects the three most important issues as goals for intervention. |
The 8-week goal-directed intervention include completing a daily home program and a weekly follow-up session with the child's occupational therapist. The parents are responsible for the day to day practice and are encouraged to let the children practice daily in their natural environment. The home-programs focus on enhancing the agreed upon goal specific task performance. They include structured practice of tasks and adaptations and modifications of the environment and the tasks. . The weekly sessions with the occupational therapist are meant to sustain motivation, follow-up on progress, adjust the home program for the coming week and support parents in how to carry out the daily interventions. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Goal Attainment Scaling (GAS)
Time Frame: Three times, at baseline, post-intervention (8-weeks) and follow-up (5-months)
|
The purpose of the Goal Attainment Scaling, GAS is to measure goal attainment.
GAS is an individualized criterion-referenced measure it involves describing current performance and specifying a range of outcomes for a specific goal, using the scale to evaluate the individual change after a specific intervention period
|
Three times, at baseline, post-intervention (8-weeks) and follow-up (5-months)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Performance scale of the Canadian Occupational Performance Measure
Time Frame: Assesed once a week up to 11 weeks which include three baseline assesments and eight assesments during the egiht weeks intervention period
|
The performance scale of the Canadian Occupational Performance Measure is a 10 point rating scale of ability of performance of a specific task, the purpose is to detect change in an individual's perception of the occupational performance.
|
Assesed once a week up to 11 weeks which include three baseline assesments and eight assesments during the egiht weeks intervention period
|
Beck Youth scales, subscale self-concept
Time Frame: Three times, at baseline, post-intervention (eigth weeks) and at follow-up (5-months)
|
The purpose of the subscale self-concept in the Beck Youth Scales is to measures the child's estimated perceived self-concept.
|
Three times, at baseline, post-intervention (eigth weeks) and at follow-up (5-months)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pediatric Evaluation of Disability Inventory (PEDI)
Time Frame: One time, at baseline
|
The purpose of the Caregiver assistance scale of the PEDI, is to describes children's need for assistance in everyday tasks within the domains of self-care, mobility and social function.
|
One time, at baseline
|
Parental questionnaire
Time Frame: Assesed once a week up to egiht weeks during the eight weeks intervention period
|
The purpose of the parental questionnaire developed for the study is to capture the parents' perception of the coaching burden and motivation to practice at home.
|
Assesed once a week up to egiht weeks during the eight weeks intervention period
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kristina Vroland-Nordstrand, Phd-student, Department of Women's and Children's Health Karolinska Institutet
- Principal Investigator: Lena Krumlinde-Sundholm, Assoc Prof, Department of women's and Children's Helath Karolinska Institutet
- Principal Investigator: Ann-Christin Eliasson, Professor, Department of Women's and Children's Health, Karolinska Institutet
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Neurodevelopmental Disorders
- Child Development Disorders, Pervasive
- Communication Disorders
- Disease
- Autism Spectrum Disorder
- Movement Disorders
- Learning Disabilities
Other Study ID Numbers
- RFR-296311
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Children
-
Duke UniversityBoston Children's Hospital; Agency for Healthcare Research and Quality (AHRQ)Enrolling by invitationChildren, Only | Children and Youth With Special Healthcare NeedsUnited States
-
Elizabeth Glaser Pediatric AIDS FoundationUnited States Agency for International Development (USAID); Biomedical Research... and other collaboratorsTerminatedOrphans, Children, Adolescents | Vulnerable Children, Adolescents | Community-basedZimbabwe
-
National Institute of Mental Health (NIMH)RecruitingHealthy Children | Children With Neurodevelopmental Disorders | Children With Neuropsychiatric Disorders | Children With Behavioral SyndromesUnited States
-
Georgetown UniversityPenn State UniversityCompleted
-
Sheffield Children's NHS Foundation TrustUniversity of Sheffield; Sheffield Hallam UniversityCompletedChildrenUnited Kingdom
-
Ann & Robert H Lurie Children's Hospital of ChicagoCompleted
-
Ann & Robert H Lurie Children's Hospital of ChicagoCompletedChildrenUnited States
-
Ann & Robert H Lurie Children's Hospital of ChicagoCompleted
-
Burke Medical Research InstituteNot yet recruiting
Clinical Trials on child-goal
-
University of AlbertaAlberta Health servicesRecruitingCerebral Palsy | Neurodevelopmental Disorders | Autism Spectrum DisorderCanada
-
Ruijin HospitalRenJi HospitalUnknown
-
Dartmouth-Hitchcock Medical CenterMedacta USARecruitingKnee Osteoarthritis | Knee Injuries | Knee Pain Chronic | Knee Injuries and DisordersUnited States
-
Stanford UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)CompletedObesity | Overweight | Weight Loss | Health BehaviorUnited States
-
Florida International UniversityLotus HouseCompletedParenting | Behavior ProblemUnited States
-
Johns Hopkins Bloomberg School of Public HealthCompletedEarly Childhood Development (ECD)
-
The Miriam HospitalActive, not recruitingObesityUnited States
-
Milton S. Hershey Medical CenterNational Institutes of Health (NIH); National Institute on Aging (NIA)Enrolling by invitationOverweight and Obesity | Walking | Physical Inactivity | Self-regulation | Cognitive HealthUnited States
-
Oswaldo Cruz FoundationConselho Nacional de Desenvolvimento Científico e Tecnológico; Rio de Janeiro...UnknownMicrocephaly | Child Development | ZIKA VIRUS INFECTIONBrazil
-
University of ChicagoNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Active, not recruiting