Movement DisorderNCT02160886
Effects of a Task Oriented Intervention With Two Goal-setting Approaches
A study testing child-goal and parent-goal in people with Movement Disorder and Learning Disability, run by Region Gävleborg at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Movement Disorder, Learning Disability, Autism Spectrum Disorder
- What is being tested?
- child-goal and parent-goal
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2011to Feb 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- involvement in another block of intensive intervention during the 5-month study period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Task Oriented Intervention for Children With Disabilities, Based on Children's or Parent's Goals, a Randomized Study.
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.
- Being tested
- child-goal, parent-goal
- Medical subject headings
- Movement Disorders, Learning Disabilities, Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
child-goalBehavioural
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-goalBehavioural
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 group | Role | What they receive |
|---|---|---|
| Child-goal | Experimental | 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. Receives: Behavioral: child-goal |
| Parent-goal | Experimental | 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. Receives: Behavioral: parent-goal |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Three times, at baseline, post-intervention (8-weeks) and follow-up (5-months)
Secondary outcomes (2)
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.
Measured: 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
The purpose of the subscale self-concept in the Beck Youth Scales is to measures the child's estimated perceived self-concept.
Measured: Three times, at baseline, post-intervention (eigth weeks) and at follow-up (5-months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2014 (estimated)
- Study startOct 2011
- Primary completionJan 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Movement DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Gävleborg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristina Vroland Nordstrand, Region Gävleborg
- Investigators
- Kristina Vroland-Nordstrand, Phd-student, Principal investigator, Department of Women's and Children's Health Karolinska InstitutetLena Krumlinde-Sundholm, Assoc Prof, Principal investigator, Department of women's and Children's Helath Karolinska InstitutetAnn-Christin Eliasson, Professor, Principal investigator, Department of women's and children's Health, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02160886
- Sponsor's protocol ID
- RFR-296311
- Status last verified
- Jun 2014
- First submitted
- 8 Jun 2014
- Last updated
- 11 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Task Oriented Intervention for Children With Disabilities, Based on Children's or Parent's Goals, a Randomized Study.
- ClinicalTrials.gov ID
- NCT02160886
- Acronym / sponsor ID
- RFR-296311
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Region GävleborgUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Jan 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 11 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Child-goal | Experimental | Behavioral: child-goalThe 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. |
| Parent-goal | Experimental | Behavioral: parent-goalThe 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. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- involvement in another block of intensive intervention during the 5-month study period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| child-goalThe 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. | Behavioural | Child-goal |
| parent-goalThe 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. | Behavioural | Parent-goal |
Primary outcome
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
2 secondary outcomes
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
Beck Youth scales, subscale self-concept
Time frame: Three times, at baseline, post-intervention (eigth weeks) and at follow-up (5-months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristina Vroland-Nordstrand, Phd-student principal investigator
Department of Women's and Children's Health Karolinska Institutet
Lena Krumlinde-Sundholm, Assoc Prof principal investigator
Department of women's and Children's Helath Karolinska Institutet
Ann-Christin Eliasson, Professor principal investigator
Department of women's and children's Health, Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing child-goal and parent-goal in people with Movement Disorder and Learning Disability, run by Region Gävleborg at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Goal Attainment Scaling (GAS) (time frame: Three times, at baseline, post-intervention (8-weeks) and follow-up (5-months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2014.