Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of a Task Oriented Intervention With Two Goal-setting Approaches

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02160886
Recruitment Status : Completed
First Posted : June 11, 2014
Last Update Posted : June 11, 2014
Sponsor:
Information provided by (Responsible Party):
Kristina Vroland Nordstrand, Region Gävleborg

Brief Summary:
A randomized trial investigating if effects of a goal-directed task oriented intervention is influenced by who takes the decision and establishes the goal (the child or the parent) and whether establishing a goal per se influence performance and goal-achievement. The main hypothesis are that children's participation in the goal-setting process would positively influence goal achievement, children's self-identified goals would be achievable and that both groups would achieve goals that were the target of a goal-directed intervention.

Condition or disease Intervention/treatment Phase
Movement Disorder Learning Disability Autism Spectrum Disorder Children Behavioral: child-goal Behavioral: parent-goal Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of a Task Oriented Intervention for Children With Disabilities, Based on Children's or Parent's Goals, a Randomized Study.
Study Start Date : October 2011
Actual Primary Completion Date : January 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine


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.

Behavioral: child-goal

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.

Behavioral: parent-goal

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.





Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.


Other Outcome Measures:
  1. 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.

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   5 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02160886


Locations
Layout table for location information
Sweden
Gävleborg County Council
Gävle, Sweden, 806 33
Sponsors and Collaborators
Region Gävleborg
Investigators
Layout table for investigator information
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
Layout table for additonal information
Responsible Party: Kristina Vroland Nordstrand, PhD-student, Region Gävleborg
ClinicalTrials.gov Identifier: NCT02160886    
Other Study ID Numbers: RFR-296311
First Posted: June 11, 2014    Key Record Dates
Last Update Posted: June 11, 2014
Last Verified: June 2014
Additional relevant MeSH terms:
Layout table for MeSH terms
Movement Disorders
Learning Disorders
Disease
Autism Spectrum Disorder
Pathologic Processes
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders
Central Nervous System Diseases
Nervous System Diseases
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations