Randomized Controlled Trial of "Let's Get Organized"; an Intervention Program for Improving Time Management Skills in Adults with Cognitive Limitations

Örebro University, Sweden8 sites in 1 country94 target enrollmentNovember 9, 2018

ConditionsNeurodevelopmental Disorders Mental Disorder

Overview

Phase: N/A
Intervention: Not specified
Conditions: Neurodevelopmental Disorders
Sponsor: Örebro University, Sweden
Enrollment: 94
Locations: 8
Primary Endpoint: Change in Assessment of Time Management Skills-Swedish, Time management sub scale at 10 weeks after intervention start and at 24 weeks after intervention start
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This project aims to evaluate and establish evidence for a novel, group-based intervention that can help people with cognitive limitations due to mental or neurodevelopmental disorders to improve their ability to manage time and organize activities. This might provide an important step towards establishing healthy life habits, getting or maintaining employment, and managing family life. Time management is a necessary skill for maintaining healthy life habits and daily occupations in modern society. People with limited cognitive function due to, for example, mental or neurodevelopmental disorders, have documented difficulties in time management, which is also related to issues with self-efficacy. Common interventions for persons with poor time management are time-assistive devices and products, but studies show that these devices alone are not enough to cover these people's needs. Structured training is needed, but there is a lack of structured interventions to enhance time management skills. The intervention program "Let's get organized" (LGO) is a manual-based group intervention aiming to enhance time management, targeted to persons with mental or neurodevelopmental disorders. In a recent feasibility study the LGO showed promising results.

This project aims to evaluate to what extent the LGO intervention is effective in improving time management, and satisfaction with daily occupations. The proposed project is a randomized-controlled trial carried out in ten psychiatric units in Sweden. Participants (n=104) will be randomly assigned to either LGO group intervention or individual Occupational Therapy intervention for ten weeks .The primary outcome of the study is self-reported time management measured by the Assessment of Time Management Skills. Secondary outcomes are occupational balance, self-efficacy, parental competence and cost-effectiveness.

Registry

clinicaltrials.gov

Start Date

November 9, 2018

End Date

August 31, 2022

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Örebro University, Sweden

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•confirmed or suspected diagnosis of a mental disorder, such as affective disorder or schizophrenia, or neurodevelopment 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

Outcomes

Primary Outcomes

Change in Assessment of Time Management Skills-Swedish, Time management sub scale at 10 weeks after intervention start and at 24 weeks after intervention start

Time Frame: baseline (pre-intervention), 10 weeks, 24 weeks

11 items, reported as 0-100 ATMS units

Secondary Outcomes

Change in Weekly Calendar Planning Activity-Swedish version No of correct appointments at 10 weeks after intervention start and at 24 weeks after intervention start(baseline (pre-intervention), 10 weeks, 24 weeks)
Change in Weekly Calendar Planning Activity Swedish version total time at 10 weeks after intervention start and at 24 weeks after intervention start(baseline (pre-intervention), 10 weeks, 24 weeks)
Change in Weekly Calendar Planning Activity Swedish version no of strategies at 10 weeks after intervention start and at 24 weeks after intervention start(baseline (pre-intervention), 10 weeks, 24 weeks)
Change in Weekly Calendar Planning Activity Swedish version rules followed at 10 weeks after intervention start and at 24 weeks after intervention start(baseline (pre-intervention), 10 weeks, 24 weeks)
Change in Weekly Calendar Planning Activity Swedish version efficacy score at 10 weeks after intervention start and at 24 weeks after intervention start(baseline (pre-intervention), 10 weeks, 24 weeks)
Change in Satisfaction with daily occupations and occupational balance (SDO-OB) activity score at 10 weeks after intervention start and at 24 weeks after intervention start(baseline (pre-intervention), 10 weeks, 24 weeks)
Change in Satisfaction with daily occupations and occupational balance (SDO-OB) satisfaction score at 10 weeks after intervention start and at 24 weeks after intervention start(baseline (pre-intervention), 10 weeks, 24 weeks)
Change in Global satisfaction score at 10 weeks after intervention start and at 24 weeks after intervention start(baseline (pre-intervention), 10 weeks, 24 weeks)
Change in Satisfaction with daily occupations and occupational balance (SDO-OB) occupational balance at 10 weeks after intervention start and at 24 weeks after intervention start(baseline (pre-intervention), 10 weeks, 24 weeks)
Change in General Self-Efficacy Scale at 10 weeks after intervention start and at 24 weeks after intervention start(baseline (pre-intervention), 10 weeks, 24 weeks)
Change in Parental Sense of Competence at 10 weeks after intervention start and at 24 weeks after intervention start(baseline (pre-intervention), 10 weeks, 24 weeks)
Change in EuroQuality of Life - 5 dimensions - 5 levels (EQ-5D-5L) item scores at 10 weeks after intervention start and at 24 weeks after intervention start(baseline (pre-intervention), 10 weeks, 24 weeks)
Change in EuroQuality of Life - 5 dimensions - 5 levels (EQ-5D-5L) global score at 10 weeks after intervention start and at 24 weeks after intervention start(baseline (pre-intervention), 10 weeks, 24 weeks)
Change in Assessment of Time Management Skills-Swedish (ATMS-S), Organization and planning sub scale at 10 weeks after intervention start and at 24 weeks after intervention start(baseline (pre-intervention), 10 weeks, 24 weeks)
Change in Assessment of Time Management Skills-Swedish (ATMS-S), Regulation of emotions sub scale at 10 weeks after intervention start and at 24 weeks after intervention start(baseline (pre-intervention), 10 weeks, 24 weeks)
Change in Diagnostic and Statistical Manual of Mental Disorders Manual-5 Self-rated level 1 Cross-Cutting Symptom Measure Adult: depression domain(baseline (pre-intervention), 10 weeks, 24 weeks)
Change in Diagnostic and Statistical Manual of Mental Disorders Manual-5 Self-rated level 1 Cross-Cutting Symptom Measure Adult: anger domain(baseline (pre-intervention), 10 weeks, 24 weeks)
Change in DSM-5 Self-rated level 1 Cross-Cutting Symptom Measure Adult: mania domain(baseline (pre-intervention), 10 weeks, 24 weeks)
Change in Diagnostic and Statistical Manual of Mental Disorders Manual-5 Self-rated level 1 Cross-Cutting Symptom Measure Adult: anxiety domain(baseline (pre-intervention), 10 weeks, 24 weeks)
Change in Diagnostic and Statistical Manual of Mental Disorders Manual-5 Self-rated level 1 Cross-Cutting Symptom Measure Adult: somatic symptoms domain(baseline (pre-intervention), 10 weeks, 24 weeks)
Change in DSM-5 Self-rated level 1 Cross-Cutting Symptom Measure Adult: suicidal ideation domain(baseline (pre-intervention), 10 weeks, 24 weeks)
Change in Diagnostic and Statistical Manual of Mental Disorders Manual-5 Self-rated level 1 Cross-Cutting Symptom Measure Adult: psychosis domain(baseline (pre-intervention), 10 weeks, 24 weeks)
Change in Diagnostic and Statistical Manual of Mental Disorders Manual-5 Self-rated level 1 Cross-Cutting Symptom Measure Adult: sleep problems domain(baseline (pre-intervention), 10 weeks, 24 weeks)
Change in Diagnostic and Statistical Manual of Mental Disorders Manual-5 Self-rated level 1 Cross-Cutting Symptom Measure Adult: memory domain(baseline (pre-intervention), 10 weeks, 24 weeks)
Change in Diagnostic and Statistical Manual of Mental Disorders Manual-5 Self-rated level 1 Cross-Cutting Symptom Measure Adult: repetitive thoughts and behaviors domain(baseline (pre-intervention), 10 weeks, 24 weeks)
Change in Diagnostic and Statistical Manual of Mental Disorders Manual-5 Self-rated level 1 Cross-Cutting Symptom Measure Adult: dissociation domain(baseline (pre-intervention), 10 weeks, 24 weeks)
Change in Diagnostic and Statistical Manual of Mental Disorders Manual-5 Self-rated level 1 Cross-Cutting Symptom Measure Adult: personality functioning domain(baseline (pre-intervention), 10 weeks, 24 weeks)
Change in Diagnostic and Statistical Manual of Mental Disorders Manual-5 Self-rated level 1 Cross-Cutting Symptom Measure Adult: substance use domain(baseline (pre-intervention), 10 weeks, 24 weeks)
Autism Quotient Short(baseline (pre-intervention), 10 weeks, 24 weeks)
Adult Attention Deficit Hyperactivity disorder Self-report Scale(baseline (pre-intervention), 10 weeks, 24 weeks)