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

Autism Spectrum Disorder Clinical Trial

Official title:

Effects of a Task Oriented Intervention for Children With Disabilities, Based on Children's or Parent's Goals, a Randomized Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02160886
• Other study ID #: RFR-296311
• Status: Completed
• Phase: N/A
• First received: June 8, 2014
• Last updated: June 9, 2014
• Start date: October 2011
• Est. completion date: February 2014

Study information

• Verified date: June 2014
• Source: Region Gävleborg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: February 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 12 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Child Development Disorders, Pervasive
• Children
• Disease
• Learning Disability
• Movement Disorder
• Movement Disorders

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.
• 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.

Locations

Country	Name	City	State
Sweden	Gävleborg County Council	Gävle

Sponsors (1)

Lead Sponsor	Collaborator
Region Gävleborg

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pediatric Evaluation of Disability Inventory (PEDI)	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	No
Other	Parental questionnaire	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	No
Primary	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	Three times, at baseline, post-intervention (8-weeks) and follow-up (5-months)	No
Secondary	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.	Assesed once a week up to 11 weeks which include three baseline assesments and eight assesments during the egiht weeks intervention period	No
Secondary	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.	Three times, at baseline, post-intervention (eigth weeks) and at follow-up (5-months)	No