Let's Get Organized Feasibility Study

NCT ID: NCT03659279

Last Updated: 2018-10-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-01
• Study Completion Date: 2017-06-30

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.

Conditions

Neurodevelopmental Disorders; Mental Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Let's Get Organized

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

Group Type: EXPERIMENTAL

Let's Get Organized

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

LGO

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dalarna County Council, Sweden

OTHER

Sponsor Role: collaborator

Region Örebro County

OTHER

Sponsor Role: collaborator

Uppsala University

OTHER

Sponsor Role: collaborator

Region Gävleborg

OTHER

Sponsor Role: collaborator

State University of New York - Downstate Medical Center

OTHER

Sponsor Role: collaborator

Örebro University, Sweden

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marie Holmefur, PhD

Role: PRINCIPAL_INVESTIGATOR

Örebro University, Sweden

Other Identifiers

ORU 2015/015

Identifier Type: -

Identifier Source: org_study_id