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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
Örebro University, Sweden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neurodevelopmental Disorders focused on measuring Time management, Group intervention, Executive function

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    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
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    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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