Let's Get Organized Feasibility Study

Pilot Study of "Let's Get Organized" - a Group Intervention for Improving Time Management

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.

Study Overview

• Status: Completed
• Conditions: Neurodevelopmental Disorders; Mental Disorder
• Intervention / Treatment: Behavioral: Let's Get Organized

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Let's Get Organized; Group intervention with 10 weekly sessions, each lasting 1.5 hours.

Behavioral: Let's Get Organized; 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.; Other Names: LGO

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change Assessment of Time Management Skills (ATMS-S) Time management sub scale	Time management (11 items) measured in ATMS units (range 0-100)	baseline (pre-intervention), 10 weeks, 24 weeks, 62-months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	baseline (pre-intervention), 10 weeks, 62-months
Change in Weekly Calendar Planning Activity (WCPA-SE) Total time	Total time No of strategies used No of rules followed (0-5)	baseline (pre-intervention), 10 weeks, 62-months
Change in Weekly Calendar Planning Activity (WCPA-SE) Strategies	No of strategies used No of rules followed (0-5)	baseline (pre-intervention), 10 weeks, 62-months
Change in Weekly Calendar Planning Activity (WCPA-SE) Rules followed	No of rules followed (range 0-5)	baseline (pre-intervention), 10 weeks, 62-months
Change in Satisfaction with Daily Occupations 13 items (SDO-13) Activity sub scale	No of activities (range 0-13)	baseline (pre-intervention), 10 weeks, 62-months
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)	baseline (pre-intervention), 10 weeks, 62-months
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)	baseline (pre-intervention), 10 weeks, 62-months
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)	baseline (pre-intervention), 10 weeks, 24 weeks, 62-months
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)	baseline (pre-intervention), 10 weeks, 24 weeks, 62-months

Collaborators and Investigators

• Sponsor: Örebro University, Sweden
• Collaborators: Uppsala University; State University of New York - Downstate Medical Center; Dalarna County Council, Sweden; Region Örebro County; Region Gävleborg

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2015
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: August 20, 2018
• First Submitted That Met QC Criteria: September 3, 2018
• First Posted (Actual): September 6, 2018

Study Record Updates

• Last Update Posted (Actual): October 26, 2018
• Last Update Submitted That Met QC Criteria: October 24, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Group intervention; Executive function; Time management
• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Mental Disorders; Neurodevelopmental Disorders
• Other Study ID Numbers: ORU 2015/015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No