Clinical trial NCT03659279: 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
Overall status: COMPLETED
Phase: NA
Conditions: Neurodevelopmental Disorders
Mental Disorder
Keywords: Time management
Group intervention
Executive function
Lead sponsor: Örebro University, Sweden
Sponsor class: OTHER
Collaborators: name: Dalarna County Council, Sweden
name: Region Örebro County
name: Uppsala University
name: Region Gävleborg
name: State University of New York - Downstate Medical Center
First posted: 2018-09-06
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pre-post intervention study
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change Assessment of Time Management Skills (ATMS-S) Time management sub scale
timeFrame: baseline (pre-intervention), 10 weeks, 24 weeks, 62-months
Secondary outcomes:
measure: Change in Weekly Calendar Planning Activity (WCPA-SE) No of appointments
timeFrame: baseline (pre-intervention), 10 weeks, 62-months
measure: Change in Weekly Calendar Planning Activity (WCPA-SE) Total time
timeFrame: baseline (pre-intervention), 10 weeks, 62-months
measure: Change in Weekly Calendar Planning Activity (WCPA-SE) Strategies
timeFrame: baseline (pre-intervention), 10 weeks, 62-months
measure: Change in Weekly Calendar Planning Activity (WCPA-SE) Rules followed
timeFrame: baseline (pre-intervention), 10 weeks, 62-months
measure: Change in Satisfaction with Daily Occupations 13 items (SDO-13) Activity sub scale
timeFrame: baseline (pre-intervention), 10 weeks, 62-months
measure: Change in Satisfaction with Daily Occupations 13 items (SDO-13) Satisfaction sub scale
timeFrame: baseline (pre-intervention), 10 weeks, 62-months
measure: Change in Satisfaction with Daily Occupations 13 items (SDO-13) Global satisfaction sub scale
timeFrame: baseline (pre-intervention), 10 weeks, 62-months
measure: Change in Assessment of Time Management Skills (ATMS-S) Organization and planning sub scale
timeFrame: baseline (pre-intervention), 10 weeks, 24 weeks, 62-months
measure: Change in Assessment of Time Management Skills (ATMS-S) Regulation of emotions sub scale
timeFrame: baseline (pre-intervention), 10 weeks, 24 weeks, 62-months
Other outcomes:
Locations:
Study officials:
affiliation: Örebro University, Sweden
name: Marie Holmefur, PhD
role: PRINCIPAL_INVESTIGATOR
References: