NCT02160886

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 8, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 11, 2014

Completed
Last Updated

June 11, 2014

Status Verified

June 1, 2014

Enrollment Period

2.3 years

First QC Date

June 8, 2014

Last Update Submit

June 9, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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)

Secondary Outcomes (2)

  • Performance scale of the Canadian Occupational Performance Measure

    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

    Three times, at baseline, post-intervention (eigth weeks) and at follow-up (5-months)

Other Outcomes (2)

  • Pediatric Evaluation of Disability Inventory (PEDI)

    One time, at baseline

  • Parental questionnaire

    Assesed once a week up to egiht weeks during the eight weeks intervention period

Study Arms (2)

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.

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.

Behavioral: parent-goal

Interventions

child-goalBEHAVIORAL

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.

Child-goal
parent-goalBEHAVIORAL

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

Eligibility Criteria

Age5 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • involvement in another block of intensive intervention during the 5-month study period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gävleborg County Council

Gävle, 806 33, Sweden

Location

MeSH Terms

Conditions

Movement DisordersLearning DisabilitiesAutism Spectrum Disorder

Condition Hierarchy (Ancestors)

Central Nervous System DiseasesNervous System DiseasesCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental DisordersChild Development Disorders, Pervasive

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD-student

Study Record Dates

First Submitted

June 8, 2014

First Posted

June 11, 2014

Study Start

October 1, 2011

Primary Completion

January 1, 2014

Study Completion

February 1, 2014

Last Updated

June 11, 2014

Record last verified: 2014-06

Locations