NCT03659279

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2015

Typical duration for not_applicable

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

March 1, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 20, 2018

Completed
17 days until next milestone

First Posted

Study publicly available on registry

September 6, 2018

Completed
Last Updated

October 26, 2018

Status Verified

October 1, 2018

Enrollment Period

1.3 years

First QC Date

August 20, 2018

Last Update Submit

October 24, 2018

Conditions

Keywords

Time managementGroup interventionExecutive function

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • Change in Weekly Calendar Planning Activity (WCPA-SE) No of appointments

    baseline (pre-intervention), 10 weeks, 62-months

  • Change in Weekly Calendar Planning Activity (WCPA-SE) Total time

    baseline (pre-intervention), 10 weeks, 62-months

  • Change in Weekly Calendar Planning Activity (WCPA-SE) Strategies

    baseline (pre-intervention), 10 weeks, 62-months

  • Change in Weekly Calendar Planning Activity (WCPA-SE) Rules followed

    baseline (pre-intervention), 10 weeks, 62-months

  • Change in Satisfaction with Daily Occupations 13 items (SDO-13) Activity sub scale

    baseline (pre-intervention), 10 weeks, 62-months

  • +4 more secondary outcomes

Study Arms (1)

Let's Get Organized

EXPERIMENTAL

Group intervention with 10 weekly sessions, each lasting 1.5 hours.

Behavioral: Let's Get Organized

Interventions

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.

Also known as: LGO
Let's Get Organized

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • intellectual disability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Neurodevelopmental DisordersMental Disorders

Study Officials

  • Marie Holmefur, PhD

    Örebro University, Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Pre-post intervention study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2018

First Posted

September 6, 2018

Study Start

March 1, 2015

Primary Completion

June 1, 2016

Study Completion

June 1, 2017

Last Updated

October 26, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share