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

Primary Purpose

Movement Disorder, Learning Disability, Autism Spectrum Disorder

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
child-goal
parent-goal
Sponsored by
Region Gävleborg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Movement Disorder

Eligibility Criteria

5 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Gävleborg County Council

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Child-goal

Parent-goal

Arm Description

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 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.

Outcomes

Primary Outcome Measures

Goal Attainment Scaling (GAS)
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

Performance scale of the Canadian Occupational Performance Measure
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
The purpose of the subscale self-concept in the Beck Youth Scales is to measures the child's estimated perceived self-concept.

Full Information

First Posted
June 8, 2014
Last Updated
June 9, 2014
Sponsor
Region Gävleborg
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1. Study Identification

Unique Protocol Identification Number
NCT02160886
Brief Title
Effects of a Task Oriented Intervention With Two Goal-setting Approaches
Official Title
Effects of a Task Oriented Intervention for Children With Disabilities, Based on Children's or Parent's Goals, a Randomized Study.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Region Gävleborg

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Movement Disorder, Learning Disability, Autism Spectrum Disorder, Children

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Child-goal
Arm Type
Experimental
Arm Description
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.
Arm Title
Parent-goal
Arm Type
Experimental
Arm Description
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 Type
Behavioral
Intervention Name(s)
child-goal
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
parent-goal
Intervention Description
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 Measure Information:
Title
Goal Attainment Scaling (GAS)
Description
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
Time Frame
Three times, at baseline, post-intervention (8-weeks) and follow-up (5-months)
Secondary Outcome Measure Information:
Title
Performance scale of the Canadian Occupational Performance Measure
Description
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.
Time Frame
Assesed once a week up to 11 weeks which include three baseline assesments and eight assesments during the egiht weeks intervention period
Title
Beck Youth scales, subscale self-concept
Description
The purpose of the subscale self-concept in the Beck Youth Scales is to measures the child's estimated perceived self-concept.
Time Frame
Three times, at baseline, post-intervention (eigth weeks) and at follow-up (5-months)
Other Pre-specified Outcome Measures:
Title
Pediatric Evaluation of Disability Inventory (PEDI)
Description
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.
Time Frame
One time, at baseline
Title
Parental questionnaire
Description
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.
Time Frame
Assesed once a week up to egiht weeks during the eight weeks intervention period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristina Vroland-Nordstrand, Phd-student
Organizational Affiliation
Department of Women's and Children's Health Karolinska Institutet
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lena Krumlinde-Sundholm, Assoc Prof
Organizational Affiliation
Department of women's and Children's Helath Karolinska Institutet
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ann-Christin Eliasson, Professor
Organizational Affiliation
Department of women's and children's Health, Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gävleborg County Council
City
Gävle
ZIP/Postal Code
806 33
Country
Sweden

12. IPD Sharing Statement

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

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