Let's Get Organized Feasibility Study
Primary Purpose
Neurodevelopmental Disorders, Mental Disorder
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Let's Get Organized
Sponsored by
About this trial
This is an interventional treatment trial for Neurodevelopmental Disorders focused on measuring Time management, Group intervention, Executive function
Eligibility Criteria
Inclusion Criteria:
- confirmed or suspected diagnosis of a mental disorder, such as affective disorder or schizophrenia, or neurodevelopmental disorder, such as autism spectrum disorder or attention deficit hyperactivity disorder/attention deficit disorder
- self-reported difficulties in time management in daily life to an extent that affects functioning in daily life negatively
Exclusion Criteria:
- intellectual disability
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Let's Get Organized
Arm Description
Group intervention with 10 weekly sessions, each lasting 1.5 hours.
Outcomes
Primary Outcome Measures
Change Assessment of Time Management Skills (ATMS-S) Time management sub scale
Time management (11 items) measured in ATMS units (range 0-100)
Secondary Outcome Measures
Change in Weekly Calendar Planning Activity (WCPA-SE) No of appointments
No of correctly entered appointments (range 0-17) Total time No of strategies used No of rules followed (0-5)
Change in Weekly Calendar Planning Activity (WCPA-SE) Total time
Total time No of strategies used No of rules followed (0-5)
Change in Weekly Calendar Planning Activity (WCPA-SE) Strategies
No of strategies used No of rules followed (0-5)
Change in Weekly Calendar Planning Activity (WCPA-SE) Rules followed
No of rules followed (range 0-5)
Change in Satisfaction with Daily Occupations 13 items (SDO-13) Activity sub scale
No of activities (range 0-13)
Change in Satisfaction with Daily Occupations 13 items (SDO-13) Satisfaction sub scale
Satisfaction sub scale score (each item is scored 1-7 and summed to a sub scale score, range 13-91, higher score indicates better satisfaction)
Change in Satisfaction with Daily Occupations 13 items (SDO-13) Global satisfaction sub scale
Global satisfaction score (range 1-5, lower score indicates better satisfaction)
Change in Assessment of Time Management Skills (ATMS-S) Organization and planning sub scale
Organization and Planning (11 items) measured in ATMS units (range 0-100)
Change in Assessment of Time Management Skills (ATMS-S) Regulation of emotions sub scale
Regulation of emotions (5 items) measured in ATMS units (range 0-100)
Full Information
NCT ID
NCT03659279
First Posted
August 20, 2018
Last Updated
October 24, 2018
Sponsor
Örebro University, Sweden
Collaborators
Dalarna County Council, Sweden, Region Örebro County, Uppsala University, Region Gävleborg, State University of New York - Downstate Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03659279
Brief Title
Let's Get Organized Feasibility Study
Official Title
Pilot Study of "Let's Get Organized" - a Group Intervention for Improving Time Management
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
March 1, 2015 (Actual)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Örebro University, Sweden
Collaborators
Dalarna County Council, Sweden, Region Örebro County, Uppsala University, Region Gävleborg, State University of New York - Downstate Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study is to pilot test the Let's Get Organized (LGO) Occupational Therapy intervention in a Swedish context by exploring possible enhancements in time management skills, aspects of executive functioning, and satisfaction with daily occupations in persons with time-management difficulties due to neurodevelopmental and/or mental disorders.
Method:
A pre-post design with 3 and 12-months follow-up is used.
The LGO intervention is a manual-based group intervention aiming to enhance time-management, targeted to persons with mental or neurodevelopmental disorders. The LGO is conducted as 10 weekly 1.5-hour group sessions. Two trained group leaders, lead each group of 6-8 participants. Goal-directed and other learning strategies are used to train effective time management habits such as maintaining a calendar and wearing a watch. All group sessions follow the same format, and each session has a set theme. Group sessions are structured with a slide presentation and a course manual, and information from the group leaders is intermixed with discussion among the participants and tasks to complete.
The primary outcome of the study is self-reported time management measured by the Assessment of Time Management Skills (ATMS-S). Secondary outcomes are executive functioning measured with the Weekly Calendar Planning Activity (WCPA) and satisfaction with daily occupations, which is measured with the interview-administered questionnaire Satisfaction with Daily Occupations 13 items (SDO-13).
Data will be collected before intervention start (pre intervention), after intervention completion (post intervention) and 3 and 12 months post intervention completion. The ATMS will be collected at all four time points. The WCPA and SDO-13 will be collected pre, post and 12 months post intervention.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurodevelopmental Disorders, Mental Disorder
Keywords
Time management, Group intervention, Executive function
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Pre-post intervention study
Masking
None (Open Label)
Allocation
N/A
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Let's Get Organized
Arm Type
Experimental
Arm Description
Group intervention with 10 weekly sessions, each lasting 1.5 hours.
Intervention Type
Behavioral
Intervention Name(s)
Let's Get Organized
Other Intervention Name(s)
LGO
Intervention Description
Group intervention aiming to enhance time-management, targeted to persons with mental or neurodevelopment disorders. Each group has 6-8 participants and is lead by two trained group leaders. Goal-directed and other learning strategies are used to train effective time management habits such as maintaining a calendar and wearing a watch. Group sessions are structured with a PowerPoint presentation and a course manual, and information from the group leaders is intermixed with discussion among the participants and tasks to complete.
Primary Outcome Measure Information:
Title
Change Assessment of Time Management Skills (ATMS-S) Time management sub scale
Description
Time management (11 items) measured in ATMS units (range 0-100)
Time Frame
baseline (pre-intervention), 10 weeks, 24 weeks, 62-months
Secondary Outcome Measure Information:
Title
Change in Weekly Calendar Planning Activity (WCPA-SE) No of appointments
Description
No of correctly entered appointments (range 0-17) Total time No of strategies used No of rules followed (0-5)
Time Frame
baseline (pre-intervention), 10 weeks, 62-months
Title
Change in Weekly Calendar Planning Activity (WCPA-SE) Total time
Description
Total time No of strategies used No of rules followed (0-5)
Time Frame
baseline (pre-intervention), 10 weeks, 62-months
Title
Change in Weekly Calendar Planning Activity (WCPA-SE) Strategies
Description
No of strategies used No of rules followed (0-5)
Time Frame
baseline (pre-intervention), 10 weeks, 62-months
Title
Change in Weekly Calendar Planning Activity (WCPA-SE) Rules followed
Description
No of rules followed (range 0-5)
Time Frame
baseline (pre-intervention), 10 weeks, 62-months
Title
Change in Satisfaction with Daily Occupations 13 items (SDO-13) Activity sub scale
Description
No of activities (range 0-13)
Time Frame
baseline (pre-intervention), 10 weeks, 62-months
Title
Change in Satisfaction with Daily Occupations 13 items (SDO-13) Satisfaction sub scale
Description
Satisfaction sub scale score (each item is scored 1-7 and summed to a sub scale score, range 13-91, higher score indicates better satisfaction)
Time Frame
baseline (pre-intervention), 10 weeks, 62-months
Title
Change in Satisfaction with Daily Occupations 13 items (SDO-13) Global satisfaction sub scale
Description
Global satisfaction score (range 1-5, lower score indicates better satisfaction)
Time Frame
baseline (pre-intervention), 10 weeks, 62-months
Title
Change in Assessment of Time Management Skills (ATMS-S) Organization and planning sub scale
Description
Organization and Planning (11 items) measured in ATMS units (range 0-100)
Time Frame
baseline (pre-intervention), 10 weeks, 24 weeks, 62-months
Title
Change in Assessment of Time Management Skills (ATMS-S) Regulation of emotions sub scale
Description
Regulation of emotions (5 items) measured in ATMS units (range 0-100)
Time Frame
baseline (pre-intervention), 10 weeks, 24 weeks, 62-months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
confirmed or suspected diagnosis of a mental disorder, such as affective disorder or schizophrenia, or neurodevelopmental disorder, such as autism spectrum disorder or attention deficit hyperactivity disorder/attention deficit disorder
self-reported difficulties in time management in daily life to an extent that affects functioning in daily life negatively
Exclusion Criteria:
intellectual disability
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie Holmefur, PhD
Organizational Affiliation
Örebro University, Sweden
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Let's Get Organized Feasibility Study
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