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

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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

Tracking Information
First Submitted Date  ICMJE June 8, 2014
First Posted Date  ICMJE June 11, 2014
Last Update Posted Date June 11, 2014
Study Start Date  ICMJE October 2011
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 9, 2014)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 9, 2014)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 9, 2014)
  • 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.
  • 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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Effects of a Task Oriented Intervention With Two Goal-setting Approaches
Official Title  ICMJE Effects of a Task Oriented Intervention for Children With Disabilities, Based on Children's or Parent's Goals, a Randomized Study.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Movement Disorder
  • Learning Disability
  • Autism Spectrum Disorder
  • Children
Intervention  ICMJE
  • 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.

  • 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.

Study Arms  ICMJE
  • 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.

    Intervention: Behavioral: child-goal
  • 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.

    Intervention: Behavioral: parent-goal
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 9, 2014)
34
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2014
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02160886
Other Study ID Numbers  ICMJE RFR-296311
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kristina Vroland Nordstrand, Region Gävleborg
Study Sponsor  ICMJE Region Gävleborg
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Region Gävleborg
Verification Date June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP