Neurodevelopmental DisordersNCT03654248
"Let's Get Organized" in Adult Psychiatric/habilitation Care
A study testing Let's Get Organized group intervention and Individual Occupational Therapy in people with Neurodevelopmental Disorders and Mental Disorder, run by Örebro University, Sweden at 8 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neurodevelopmental Disorders, Mental Disorder
- What is being tested?
- Let's Get Organized group intervention and Individual Occupational Therapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 8 sitesSweden
- Study dates
- 9 Nov 2018to 31 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- intellectual disability
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Sweden8 sites
Öppenvårdspsykiatrisk mottagning
Falun, Dalarna County, 79131
Hallsberg psykiatrisk öppenvård
Hallsberg, Örebro County, 69436
Karlskoga psykiatrisk öppenvård
Karlskoga, Örebro County, 69181
Lindesberg psykiatrisk öppenvård
Lindesberg, Örebro County, 71182
USÖ psykiatrisk öppenvård och affektiva enhet
Örebro, Örebro County, 70116
Vuxenhabiliteringen - Autismteamet
Örebro, Örebro County, 70116
Habiliteringscenter Brommaplan vuxna, Habilitering och Hälsa, Region Stockholm
Stockholm
Neuropsykiatriska mottagningen, Akademiska sjukhuset
Uppsala
About this study
Official title: Randomized Controlled Trial of "Let's Get Organized"; an Intervention Program for Improving Time Management Skills in Adults with Cognitive Limitations
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.
- Conditions
- Neurodevelopmental Disorders, Mental Disorder
- Being tested
- Let's Get Organized group intervention, Individual Occupational Therapy
- Keywords
- Time management, Group intervention, Executive function
- Medical subject headings
- Neurodevelopmental Disorders, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Let's Get Organized group interventionBehavioural
Also called LGO
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 PowerPoint presentation and a course manual, an information from the group leaders is intermixed with discussion among the participants and tasks to complete.
Individual Occupational TherapyDevice
Individual meetings with Occupational Therapist (standard therapy) during a 10-week period. Number of meetings and exact nature of intervention depends on the client's needs and is decided by the treating occupational therapist. Interventions will include prescription or instruction regarding time assistive devices and instructions regarding structure and planning of everyday life.
| Study group | Role | What they receive |
|---|---|---|
| Let's Get Organized group intervention | Experimental | Group intervention with 10 weekly sessions, each lasting 1,5 hours Receives: Behavioral: Let's Get Organized group intervention |
| Individual Occupational Therapy | Active comparator | Individual intervention lasting 10 weeks Receives: Device: Individual Occupational Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
11 items, reported as 0-100 ATMS units
Measured: baseline (pre-intervention), 10 weeks, 24 weeks
Secondary outcomes (30)
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
Performance test of executive functioning. No of correctly entered appointments (range 0-17)
Measured: 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
Performance test of executive functioning. Total time
Measured: 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
Performance test of executive functioning. No of strategies used more strategies are better
Measured: 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
Performance test of executive functioning. No of rules followed (range 0-5) More rules followed are better
Measured: 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
Performance test of executive functioning. Efficacy score (high score is better)
Measured: 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
No of activities (range 0-17, higher scores are better)
Measured: 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
Satisfaction score (range 13-91, higher scores are better)
Measured: 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
Global satisfaction score (range 1-5, lower scores are better)
Measured: 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
Occupational balance (nominal data)
Measured: 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
Self-efficacy (range 0-40, higher score is better)
Measured: 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
Sense of competence (range 15-90, higher score is better)
Measured: 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
Individual item scores on 5 items scored 1-5
Measured: 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
One visual-analogue-scale answer (range 0-100)
Measured: 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
11 items, reported as 0-100 ATMS units
Measured: 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
5 items, reported as 0-100 ATMS units
Measured: 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
2 items, reported as 0-8 points
Measured: 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
1 item, reported as 0-4 points
Measured: baseline (pre-intervention), 10 weeks, 24 weeks
Change in DSM-5 Self-rated level 1 Cross-Cutting Symptom Measure Adult: mania domain
2 items, reported as 0-8 points
Measured: 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
3 items, reported as 0-12 points
Measured: 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
2 items, reported as 0-8 points
Measured: baseline (pre-intervention), 10 weeks, 24 weeks
Change in DSM-5 Self-rated level 1 Cross-Cutting Symptom Measure Adult: suicidal ideation domain
1 items, reported as 0-4 points
Measured: 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
2 items, reported as 0-8 points
Measured: 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
1 items, reported as 0-4 points
Measured: 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
1 items, reported as 0-4 points
Measured: 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
2 items, reported as 0-8 points
Measured: 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
1 items, reported as 0-4 points
Measured: 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
2 items, reported as 0-8 points
Measured: 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
3 items, reported as 0-12 points
Measured: baseline (pre-intervention), 10 weeks, 24 weeks
Autism Quotient Short
28 items, 28-112 points
Measured: baseline (pre-intervention), 10 weeks, 24 weeks
Adult Attention Deficit Hyperactivity disorder Self-report Scale
18 items, score 1-90
Measured: baseline (pre-intervention), 10 weeks, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study start9 Nov 2018
- Primary completion31 Aug 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neurodevelopmental DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Örebro University, Sweden
- Sponsor type
- University, hospital or other
- Collaborators
- Region Örebro County, Dalarna County Council, Sweden, Uppsala University, Region Gävleborg, State University of New York - Downstate Medical Center, Uppsala County Council, Sweden
- Responsible party
- Sponsor
- Investigators
- Marie Holmefur, PhD, Principal investigator, Örebro University, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03654248
- Sponsor's protocol ID
- ORU 2018/191
- Status last verified
- Mar 2023
- First submitted
- 20 Aug 2018
- Last updated
- 18 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Holmefur M, Roshanay A, White S, Janeslatt G, Vimefall E, Lidstrom-Holmqvist K. Evaluation of the "Let's Get Organized" group intervention to improve time management: protocol for a multi-centre randomised controlled trial. Trials. 2021 Sep 19;22(1):640. doi: 10.1186/s13063-021-05578-x.
PubMed 34538253
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of "Let's Get Organized"; an Intervention Program for Improving Time Management Skills in Adults with Cognitive Limitations
- ClinicalTrials.gov ID
- NCT03654248
- Acronym / sponsor ID
- ORU 2018/191
- Conditions
- Neurodevelopmental Disorders, Mental Disorder
- Keywords
- Time management, Group intervention, Executive function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Örebro University, SwedenUniversity, hospital or other
- Collaborators
- Region Örebro County, Dalarna County Council, Sweden, Uppsala University, Region Gävleborg, State University of New York - Downstate Medical Center, Uppsala County Council, Sweden
- Study start
- 9 Nov 2018 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 31 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Let's Get Organized group intervention | Experimental | Behavioral: Let's Get Organized group interventionGroup intervention with 10 weekly sessions, each lasting 1,5 hours |
| Individual Occupational Therapy | Active comparator | Device: Individual Occupational TherapyIndividual intervention lasting 10 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- intellectual disability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Let's Get Organized group interventionAlso: LGOGroup 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 PowerPoint presentation and a course manual, an information from the group leaders is intermixed with discussion among the participants and tasks to complete. | Behavioural | Let's Get Organized group intervention |
| Individual Occupational TherapyIndividual meetings with Occupational Therapist (standard therapy) during a 10-week period. Number of meetings and exact nature of intervention depends on the client's needs and is decided by the treating occupational therapist. Interventions will include prescription or instruction regarding time assistive devices and instructions regarding structure and planning of everyday life. | Device | Individual Occupational Therapy |
Primary outcome
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
30 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: baseline (pre-intervention), 10 weeks, 24 weeks
Change in DSM-5 Self-rated level 1 Cross-Cutting Symptom Measure Adult: mania domain
Time frame: 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
Time frame: 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
Time frame: baseline (pre-intervention), 10 weeks, 24 weeks
Change in DSM-5 Self-rated level 1 Cross-Cutting Symptom Measure Adult: suicidal ideation domain
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: baseline (pre-intervention), 10 weeks, 24 weeks
Autism Quotient Short
Time frame: baseline (pre-intervention), 10 weeks, 24 weeks
Adult Attention Deficit Hyperactivity disorder Self-report Scale
Time frame: baseline (pre-intervention), 10 weeks, 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2024.
- Background: PubMed 34538253Holmefur M, Roshanay A, White S, Janeslatt G, Vimefall E, Lidstrom-Holmqvist K. Evaluation of the "Let's Get Organized" group intervention to improve time management: protocol for a multi-centre randomised controlled trial. Trials. 2021 Sep 19;22(1):640. doi: 10.1186/s13063-021-05578-x.
- Individual participant dataSharing planned: No
Related trials for Neurodevelopmental Disorders
Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
RecruitingPhase 1
Cannabidiol (CBD) in Adults With ASD
Autism Spectrum Disorder
Not yet recruitingPhase 2
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
Conduct Disorder
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie Holmefur, PhD principal investigator
Örebro University, Sweden
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Let's Get Organized group intervention and Individual Occupational Therapy in people with Neurodevelopmental Disorders and Mental Disorder, run by Örebro University, Sweden at 8 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03654248, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2024.