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The proposed study will test the usability and feasibility of a novel cognitive training (COGMUSE) for autistic adults with co-occurring insomnia (COGMUSE- AUT). Participants (n=15) will complete the cognitive training intervention for 60 minutes per day, 3 times per week for 6 weeks at home totaling to 18 hours. Weekly check-ins will be conducted by study staff over Teams to ensure adherence to the treatment and provide an opportunity for qualitative feedback on the game sessions played. During these 6 weeks, participants will fill out daily (2x/day) electronic sleep diaries and wear an actigraph device (GENEActiv). GENEActiv is a watch-like device that monitors light and movement activity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COGMUSE-AUT | Experimental | Participants will complete the computerized cognitive training intervention for 60 minutes per day, 3 times per week for 6 weeks at home totaling to 18 hours. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COGMUSE-AUT | Behavioral | The computerized training exercises and brain games help stimulate cognitive functions while providing real-time monitoring on the evolution of participants' skills. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Cognition-National Institute of Health Toolbox | A computerized cognitive test battery measuring performance across several domains: executive function (Flanker inhibitory control task), Dimensional Card Sort Test (measures cognitive flexibility, accuracy score), working memory (List Sorting Task), verbal (episodic) memory (Auditory Verbal Learning Task) will be administered. | Up to 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Slee-Daily Actigraphy | GENEActiv (Activiinsights), a watch-like device that monitors light and gross motor activity, will be worn 24 hours/7 days for 2 weeks at each assessment point. | Up to 10 weeks |
| Subjective Sleep- Electronic Daily Sleep Diaries |
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Inclusion Criteria:
2a) ASDb: a) previous DSM diagnosis of ASD (self-reported by ASD adult and guardian; confirmed by clinical documentation provided to project coordinator), 2) evaluation using gold-standard diagnostic tools (i.e., Autism Diagnostic Observation Schedule (ADOS) and/or Autism Diagnostic Interview -Revised [ADI-R]).
3a) Insomnia: a) insomnia complaints for 6+ months that b) occur despite adequate opportunity and circumstances for sleep, c) consist of 1 or more of the following: difficulty falling asleep, staying asleep, or waking up too early, d) daytime dysfunction (mood, cognitive, social, occupational) due to insomnia, f) baseline diaries and actigraphy indicate >30 minutes of sleep onset latency or wake after sleep onset on 6 or more nights.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ashley F Curtis, PhD | University of South Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South Florida | Tampa | Florida | 33620 | United States |
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D020919 | Sleep Disorders, Intrinsic |
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Pilot test COGMUSE-AUT in a small sample of autistic adults with co-occurring insomnia on primary and secondary outcomes.
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Online diaries completed each morning (~5 mins) during 2-week assessment periods and 6 weeks training. Variables: sleep onset latency (time from lights-out until sleep onset), wake time after sleep onset, sleep efficiency (% time spent sleeping while in bed). |
| Up to 10 weeks |
| Insomnia Severity Index | 5-item survey completed by adult with autism and parent/guardian if needed. Brief measure of current perception of insomnia symptom severity, distress and daytime impairment. Commonly used in insomnia treatment outcome research. | Up to 10 weeks |
| Sleep Habits Questionnaire | Modified Sleep Habits Questionnaire, based on child version and modified for adults. This questionnaire gauges sleep habits and possible difficulties with sleep. | Up to 10 weeks |
| Pre-Sleep Arousal | -Pre-sleep Arousal Scale is a 16-item self-report questionnaire comprising both cognitive and somatic manifestations of arousal. This questionnaire will be completed by autistic adult with assistance from parent/guardian as needed. | Up to 10 weeks |
| WHO Quality of Life-BREF | This measure assesses quality of life (QOL) within the context of an individual's culture, value systems, personal goals, standards and concerns. | Up to 10 weeks |
| Mood | State-Trait Anxiety Inventory: Inventory that asks respondents to rate how true 20 self-descriptive statements (e.g., I feel calm) are on a 4-point scale (1 = not at all, 4 = very much so). Typically, respondents are asked to rate statements according to how they generally feel (trait-anxiety scale) and how they feel in the current moment (state-anxiety scale). Total scores range from 20 to 80, with higher scores indicating greater maladjustment. | Up to 10 weeks |
| Depression | - Beck Depression Inventory (II): 21-item inventory that asks respondents to rate on a scale of 0 (no depressive feelings) to 3 (most depressive feelings) their feelings towards various aspects of daily living/situations. Higher total scores indicate worse depressive symptoms. | Up to 10 weeks |
| Adaptive Behavior Assessment System (ABAS-III) | Adaptive functioning --This assessment measures behaviors suitable for adults displayed in several domains such as communication, community use, functional academics, home living, health and safety, leisure, self-care, self-direction, social, and work. The assessment will be filled by the adult with autism with the help of the caregiver if necessary. Answers are provided in a likert scale with 0=is not able to do this behavior to 3= always (or almost always). | Up to 10 weeks |
| Game-related experience (completed during intervention) | Sessions played -- The graduate research assistant will check adherence through an online portal storing COGMUSESM data during weekly Teams check-ins with participant. Participants will also provide qualitative feedback on the game sessions played. Weekly game -- Maximum test scores recorded. Game Engagement Questionnaire - Completed at the end of intervention; Participants rate from 0 (none) to 4 (extremely) the degree to which they agree with 33 aspects of game experiences. Total score measures game engagement. | Up to 10 weeks |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |