Sleep DisturbanceNCT07007819
Community-Engaged Sleep Intervention for School-Aged Children With Autism Spectrum Disorder
A study testing Modified Sleep and Circadian Intervention in people with Sleep Disturbance and Autism Spectrum Disorder, run by Case Western Reserve University at 1 site in United States.
Trial summary
As many as 78% of children with autism spectrum disorder (ASD) have significant sleep disturbance compared to 20% of children without ASD. In children with ASD, shorter sleep duration and lower sleep efficiency, are associated with disruptive behavior, anxiety, and increased parental stress. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Sleep Disturbance, Autism Spectrum Disorder
- What is being tested?
- Modified Sleep and Circadian Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Aug 2025to 9 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children 6-12 years with a clinical diagnosis of ASD defined by the Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition and corroborated by the Social Communication Questionnaire-lifetime score of ≥ 15.
- Child must have ≥ 1 poor sleep health dimensions (B-SATED).
- Child is not currently participating in any sleep-related interventions.
- Child has not had any medication changes within the past month that interfere with sleep.
- If present, the child must have a treated OSA (mild or less) diagnosis and willingness to continue treatment (≥80% adherence).
- Parent must be an adult legal guardian proficient in English.
Who cannot join
- Children with an untreated complex medical condition that interferes with sleep (e.g., epilepsy, nocturnal seizures).
- Children with moderate to severe OSA.
- Unable to complete protocol (e.g., serious behavioral concerns, bereavement, currently homeless).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
About this study
Official title: Community-Engaged Behavioral Sleep and Circadian Intervention for School-Aged Children With Autism Spectrum Disorder
As many as 78% of children with autism spectrum disorder (ASD) have significant sleep disturbance compared to 20% of children without ASD. In children with ASD, shorter sleep duration and lower sleep efficiency, are associated with disruptive behavior, anxiety, and increased parental stress. Therefore, multiple sleep dimensions (B-SATED: behaviors, satisfaction, alertness, timing, efficiency, duration) are appropriate therapeutic targets to improve daytime behavioral functioning and other psychosocial outcomes. The primary objective is to evaluate the implementation of a modification of a behavioral sleep and circadian intervention to improve multiple sleep dimension in school-age children with ASD. To accomplish this objective, a 12-week, randomized pilot study will be conducted to assess the feasibility, acceptability, and preliminary efficacy of a modified behavioral sleep and circadian intervention with up to 50 school-age children with ASD, to determine whether the intervention improves multiple dimensions of sleep (B-SATED: behaviors, satisfaction, alertness, timing, efficiency, duration), daytime behavior, quality of life, parental stress, and parental self-efficacy.
This modified intervention is guided by the Pediatric Sleep Health Framework that encourages improvement in six pediatric sleep dimensions (B-SATED): sleep behaviors; parents' satisfaction with child sleep; daytime alertness/sleepiness; appropriate timing of sleep within the 24-hour day; sleep efficiency, i.e., ease of falling and staying asleep; and sleep duration. The Sadeh and Anders Sleep-Wake Regulation Model was used to propose linkages between outcomes. The investigators hypothesize that parents implementing the modified intervention will improve the primary outcome (clinician- and parent-ratings of child sleep) and secondary child (sleep dimensions, daytime behavior, quality of life) and parent outcomes (stress and self-efficacy).
Read the detailed description
Study Overview: The overall goals are to adapt and evaluate the feasibility, acceptability, and preliminary efficacy of a modified behavioral sleep and circadian intervention for school-age children with autism spectrum disorder (ASD). Initial modifications were based on individual qualitative interviews with parents and feedback from a community advisory board to revise the existing intervention. A qualitative descriptive approach guided the modification of the intervention's content, format, delivery, and identification of barriers and facilitators. End-user feedback and debriefing were conducted with parents who participated in the qualitative interviews.
The final phase of the study involves conducting a randomized pilot study to assess the feasibility, acceptability, and preliminary efficacy of this intervention prototype. Our primary objective is to evaluate the implementation of a modified sleep and circadian intervention to improve multiple sleep dimensions in school-age children with ASD. To accomplish this objective, a 12-week, randomized pilot study will be conducted with up to 50 school-age children with ASD to assess the feasibility, acceptability, and preliminary efficacy of the intervention. The study aims to determine whether the intervention improves multiple dimensions of sleep (B-SATED: behaviors, satisfaction, alertness, timing, efficiency, duration), daytime behavior, quality of life, parental stress, and parental self-efficacy. The investigators hypothesize that parents implementing the modified intervention will improve the primary outcome (clinician- and parent-ratings of child sleep) and secondary child (sleep dimensions, daytime behavior, quality of life) and parent outcomes (stress and self-efficacy).
Study Design: A two-arm, RCT will be used to evaluate the preliminary efficacy, feasibility, and acceptability of the modified behavioral sleep intervention compared to a time-balanced attention control condition (enhanced usual care). Data collection will include T0 baseline measures (parent ratings and 7 nights of actigraphy sleep monitoring). After completing the baseline measures, participants will be allocated to either the experimental condition or the enhanced usual care control condition. T1 will include immediate post-intervention measures at 3 months (parent ratings and 7 nights of actigraphy sleep monitoring). T2 will include repeating measures at 6 months post-intervention (parent ratings only).
- Conditions
- Sleep Disturbance, Autism Spectrum Disorder
- Being tested
- Modified Sleep and Circadian Intervention, Enhanced Usual Care
- Keywords
- Sleep and Circadian Intervention, Autism Spectrum Disorder, Pediatrics, Sleep Disturbance
- Medical subject headings
- Parasomnias, Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Sleep and Circadian InterventionBehavioural
The modified sleep and circadian intervention has 5 individual sessions that will be delivered via Zoom to parents over 12 weeks and consists of 4 cross-cutting modules (functional analysis, goal setting, motivational interviewing, sleep education), 5 core sessions, and 7 optional modules that are delivered based on personalized treatment goals. The intervention format is as follows: (1) 60-minute session with consultation on setting goals and developing an action plan to improve sleep timing, quantity, and regularity; (2) 5-minute weekly follow-ups and a 3-night sleep diary; and (3) four 30-45-minute booster sessions every 3 weeks. Child attendance is optional.
Enhanced Usual CareBehavioural
Enhanced Usual Care (EUC) is an active comparison treatment balanced for time and attention. Participants will be asked to maintain their typical sleep schedules. EUC sessions will review the interrelationships between stress, diet, health, exercise, and behavior, with a sleep education portion < 10 minutes and no encouragement to change behavior. EUC sessions will be used to establish rapport and promote study retention. EUC participants will not complete weekly sleep diaries. At the end of Week 12, EUC participants will receive a 1-hour optional Zoom session with the PI on sleep education.
| Study group | Role | What they receive |
|---|---|---|
| Modified Sleep and Circadian Intervention | Experimental | Up to 50 children will be randomly assigned (1:1) to the modified sleep and circadian intervention or enhanced usual care for 12 weeks. Receives: Behavioral: Modified Sleep and Circadian Intervention |
| Enhanced Usual Care Control Condition | Active comparator | Up to 50 children will be randomly assigned (1:1) to the modified sleep and circadian intervention or enhanced usual care for 12 weeks. Receives: Behavioral: Enhanced Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Improvement Scale of the Clinical Global Impressions Scale (CGI-I)
The improvement scale of Clinical Global Impression (CGI-I) Scale will be used to evaluate treatment-related improvement. The CGI-Improvement scale is rated by a clinician on a scale of 1 to 7, with 1 representing "very much improved" and 7 representing "very much worse." The CGI-Improvement scale (Scores 1 "very much improved" or 2 "much improved") will be used to identify a positive response to treatment.
Measured: Baseline, Post-Intervention (Week 12), and Follow Up (Week 24)
Change in the Pediatric Autism Insomnia Rating Scale (PAIRS)
The PAIRS is a parent rating of insomnia and sleep-related impairments over the past two weeks in children with ASD age 3 to 12 years. The PAIRS is a single-factor measure comprising 21 items that assess difficulties with falling and/or staying asleep, as well as the impact of sleep problems on the child and the family. Items are scored: 0 (mild = not present, not a problem) to 3 (severe = frequent and a major problem). Higher scores indicate greater severity.
Measured: Baseline, Post-Intervention (Week 12), and Follow Up (Week 24)
Secondary outcomes (6)
Change in Child Sleep Dimensions Composite Score
Behaviors, Satisfaction, Alertness, Timing, Efficiency, Duration (B-SATED) sleep dimensions is a composite score that will be measured by the Modified Children's Sleep Habits Questionnaire (M-CSHQ), sleep diaries, and/or actigraphy [Poor sleep dimensions = Behaviors-M-CSHQ and sleep diary items related to bedtime routine consistency, sleep onset associations, co-sleeping, caffeine intake, and bedtime media use-endorsement of any of these items indicates poor sleep behaviors; Satisfaction-M-CSHQ total ≥ 33; Alertness/Sleepiness-M-CSHQ alertness score ≥ 10; Timing/Regularity-variability in bed/waketimes ≥ 1 hour; sleep Efficiency < 85%; sleep Duration < 9 hours per 24-hour period]. One overall score is derived from the six dimensions. Each dimension will be dichotomized as "1=good" or "0=poor" with scores ranging from 0-6, with a higher score indicating better sleep. Cutoffs are based on pediatric sleep recommendations.
Measured: Baseline, Post-Intervention (Week 12)
Change in Child Daytime Behavior
The Aberrant Behavior Checklist (ABC) is a parent rating of child behavior with five subscales: Irritability (15 items), Lethargy/Social Withdrawal (16 items), Stereotypic Behavior (7 items), Hyperactivity/ Noncompliance (16 items), and Inappropriate Speech (4 items). The ABC consists of 58-items scored: 0 (never a problem) to 3 (severe problem). Higher scores indicate greater severity.
Measured: Baseline, Post-Intervention (Week 12), and Follow Up (Week 24)
Change in Child Health-Related Quality of Life
The PedsQL 4.0 will be used to measure pediatric health-related quality of life (HRQoL). The 23-item PedsQL Generic Core Scale is used to measure pediatric HRQoL and covers four domains related to functioning: Physical (8 items), Emotional (5 items), Social (5 items), and School (5 items for children). Items are scored on a 5-point Likert-type scale (range, 0 = never a problem; 4 = almost always a problem). To compute summary scores, items are reversed scored and linearly transformed to a 0-100 scale. Higher scores indicate better pediatric HRQoL.
Measured: Baseline, Post-Intervention (Week 12), and Follow Up (Week 24)
Change in Parental Stress
The Parenting Stress Index-Short Form (PSI-SF) is a 36-item tool specifically designed to measure parenting stress. Items are scored on a 5-point likert scale with 1 = strongly disagree and 5 = strongly agree. There are three subscales of the PSI-SF, each containing 12 items: Parental Distress, Parent-Child Dysfunctional Interaction, and Difficult Child. Total scores can range from 36 to 180. Higher scores indicate higher levels of parenting stress.
Measured: Baseline, Post-Intervention (Week 12), and Follow Up (Week 24)
Change in Parental Sense of Competence
The Parenting Sense of Competence Scale (PSOC) consists of 17-items that are designed to measure parental satisfaction and self-efficacy. Items are scored on a 6-point scale with scores ranging from "strongly agree" = 6 to "strongly disagree" = 1. Higher scores reflect greater parental competence.
Measured: Baseline, Post-Intervention (Week 12), and Follow Up (Week 24)
Change in Parental Sleep Quality
The Pittsburgh Sleep Quality Index (PSQI) is a 19-item questionnaire designed to assess sleep quality and disturbances. It evaluates seven components of sleep, which are combined to produce a global score ranging from 0 to 21. A total score of 5 or higher indicates clinically significant sleep difficulties, with higher scores reflecting poorer sleep quality.
Measured: Baseline and Post-Intervention (Week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2025
- Study start27 Aug 2025
- Primary completion9 Dec 2026 (estimated)
- Study completion9 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisturbanceStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The sleep and circadian intervention is guided by the Pediatric Sleep Health Framework that encourages improvement in six pediatric sleep dimensions (B-SATED): sleep behaviors; parents' satisfaction with child sleep; daytime alertness/sleepiness; appropriate timing of sleep within the 24-hour day; sleep efficiency, i.e., ease of falling and staying asleep; and sleep duration. The Sadeh and Anders Sleep-Wake Regulation Model was used to propose linkages between outcomes.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Case Western Reserve University
- Sponsor type
- University, hospital or other
- Collaborators
- American Academy of Sleep Medicine, National Institutes of Health (NIH), National Center for Advancing Translational Sciences (NCATS), University Hospitals Cleveland Medical Center
- Responsible party
- Principal investigator, Megan Wenzell, Case Western Reserve University
- Investigators
- Megan L Wenzell, PhD, Principal investigator, Case Western Reserve University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07007819
- Sponsor's protocol ID
- STUDY20240404
- Status last verified
- Aug 2026
- First submitted
- 19 May 2025
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community-Engaged Behavioral Sleep and Circadian Intervention for School-Aged Children With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT07007819
- Acronym / sponsor ID
- STUDY20240404
- Conditions
- Sleep Disturbance, Autism Spectrum Disorder
- Keywords
- Sleep and Circadian Intervention, Autism Spectrum Disorder, Pediatrics, Sleep Disturbance
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Case Western Reserve UniversityUniversity, hospital or other
- Collaborators
- American Academy of Sleep Medicine, National Institutes of Health (NIH), National Center for Advancing Translational Sciences (NCATS), University Hospitals Cleveland Medical Center
- Study start
- 27 Aug 2025 (actual)
- Primary completion
- 9 Dec 2026 (estimated)
- Study completion
- 9 Dec 2026 (estimated)
- First posted
- 6 Jun 2025 (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.
As many as 78% of children with autism spectrum disorder (ASD) have significant sleep disturbance compared to 20% of children without ASD. In children with ASD, shorter sleep duration and lower sleep efficiency, are associated with disruptive behavior, anxiety, and increased parental stress. Therefore, multiple sleep dimensions (B-SATED: behaviors, satisfaction, alertness, timing, efficiency, duration) are appropriate therapeutic targets to improve daytime behavioral functioning and other psychosocial outcomes. The primary objective is to evaluate the implementation of a modification of a behavioral sleep and circadian intervention to improve multiple sleep dimension in school-age children with ASD. To accomplish this objective, a 12-week, randomized pilot study will be conducted to assess the feasibility, acceptability, and preliminary efficacy of a modified behavioral sleep and circadian intervention with up to 50 school-age children with ASD, to determine whether the intervention improves multiple dimensions of sleep (B-SATED: behaviors, satisfaction, alertness, timing, efficiency, duration), daytime behavior, quality of life, parental stress, and parental self-efficacy.
This modified intervention is guided by the Pediatric Sleep Health Framework that encourages improvement in six pediatric sleep dimensions (B-SATED): sleep behaviors; parents' satisfaction with child sleep; daytime alertness/sleepiness; appropriate timing of sleep within the 24-hour day; sleep efficiency, i.e., ease of falling and staying asleep; and sleep duration. The Sadeh and Anders Sleep-Wake Regulation Model was used to propose linkages between outcomes. The investigators hypothesize that parents implementing the modified intervention will improve the primary outcome (clinician- and parent-ratings of child sleep) and secondary child (sleep dimensions, daytime behavior, quality of life) and parent outcomes (stress and self-efficacy).
Detailed description
Study Overview: The overall goals are to adapt and evaluate the feasibility, acceptability, and preliminary efficacy of a modified behavioral sleep and circadian intervention for school-age children with autism spectrum disorder (ASD). Initial modifications were based on individual qualitative interviews with parents and feedback from a community advisory board to revise the existing intervention. A qualitative descriptive approach guided the modification of the intervention's content, format, delivery, and identification of barriers and facilitators. End-user feedback and debriefing were conducted with parents who participated in the qualitative interviews.
The final phase of the study involves conducting a randomized pilot study to assess the feasibility, acceptability, and preliminary efficacy of this intervention prototype. Our primary objective is to evaluate the implementation of a modified sleep and circadian intervention to improve multiple sleep dimensions in school-age children with ASD. To accomplish this objective, a 12-week, randomized pilot study will be conducted with up to 50 school-age children with ASD to assess the feasibility, acceptability, and preliminary efficacy of the intervention. The study aims to determine whether the intervention improves multiple dimensions of sleep (B-SATED: behaviors, satisfaction, alertness, timing, efficiency, duration), daytime behavior, quality of life, parental stress, and parental self-efficacy. The investigators hypothesize that parents implementing the modified intervention will improve the primary outcome (clinician- and parent-ratings of child sleep) and secondary child (sleep dimensions, daytime behavior, quality of life) and parent outcomes (stress and self-efficacy).
Study Design: A two-arm, RCT will be used to evaluate the preliminary efficacy, feasibility, and acceptability of the modified behavioral sleep intervention compared to a time-balanced attention control condition (enhanced usual care). Data collection will include T0 baseline measures (parent ratings and 7 nights of actigraphy sleep monitoring). After completing the baseline measures, participants will be allocated to either the experimental condition or the enhanced usual care control condition. T1 will include immediate post-intervention measures at 3 months (parent ratings and 7 nights of actigraphy sleep monitoring). T2 will include repeating measures at 6 months post-intervention (parent ratings only).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The sleep and circadian intervention is guided by the Pediatric Sleep Health Framework that encourages improvement in six pediatric sleep dimensions (B-SATED): sleep behaviors; parents' satisfaction with child sleep; daytime alertness/sleepiness; appropriate timing of sleep within the 24-hour day; sleep efficiency, i.e., ease of falling and staying asleep; and sleep duration. The Sadeh and Anders Sleep-Wake Regulation Model was used to propose linkages between outcomes.
| Arm | Type | Receives |
|---|---|---|
| Modified Sleep and Circadian Intervention | Experimental | Behavioral: Modified Sleep and Circadian InterventionUp to 50 children will be randomly assigned (1:1) to the modified sleep and circadian intervention or enhanced usual care for 12 weeks. |
| Enhanced Usual Care Control Condition | Active comparator | Behavioral: Enhanced Usual CareUp to 50 children will be randomly assigned (1:1) to the modified sleep and circadian intervention or enhanced usual care for 12 weeks. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Children 6-12 years with a clinical diagnosis of ASD defined by the Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition and corroborated by the Social Communication Questionnaire-lifetime score of ≥ 15.
- Child must have ≥ 1 poor sleep health dimensions (B-SATED).
- Child is not currently participating in any sleep-related interventions.
- Child has not had any medication changes within the past month that interfere with sleep.
- If present, the child must have a treated OSA (mild or less) diagnosis and willingness to continue treatment (≥80% adherence).
Key exclusion criteria (3 listed)
- Children with an untreated complex medical condition that interferes with sleep (e.g., epilepsy, nocturnal seizures).
- Children with moderate to severe OSA.
- Unable to complete protocol (e.g., serious behavioral concerns, bereavement, currently homeless).
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 |
|---|---|---|
| Modified Sleep and Circadian InterventionThe modified sleep and circadian intervention has 5 individual sessions that will be delivered via Zoom to parents over 12 weeks and consists of 4 cross-cutting modules (functional analysis, goal setting, motivational interviewing, sleep education), 5 core sessions, and 7 optional modules that are delivered based on personalized treatment goals. The intervention format is as follows: (1) 60-minute session with consultation on setting goals and developing an action plan to improve sleep timing, quantity, and regularity; (2) 5-minute weekly follow-ups and a 3-night sleep diary; and (3) four 30-45-minute booster sessions every 3 weeks. Child attendance is optional. | Behavioural | Modified Sleep and Circadian Intervention |
| Enhanced Usual CareEnhanced Usual Care (EUC) is an active comparison treatment balanced for time and attention. Participants will be asked to maintain their typical sleep schedules. EUC sessions will review the interrelationships between stress, diet, health, exercise, and behavior, with a sleep education portion < 10 minutes and no encouragement to change behavior. EUC sessions will be used to establish rapport and promote study retention. EUC participants will not complete weekly sleep diaries. At the end of Week 12, EUC participants will receive a 1-hour optional Zoom session with the PI on sleep education. | Behavioural | Enhanced Usual Care Control Condition |
Primary outcome
The Improvement Scale of the Clinical Global Impressions Scale (CGI-I)
Time frame: Baseline, Post-Intervention (Week 12), and Follow Up (Week 24)
The improvement scale of Clinical Global Impression (CGI-I) Scale will be used to evaluate treatment-related improvement. The CGI-Improvement scale is rated by a clinician on a scale of 1 to 7, with 1 representing "very much improved" and 7 representing "very much worse." The CGI-Improvement scale (Scores 1 "very much improved" or 2 "much improved") will be used to identify a positive response to treatment.
Change in the Pediatric Autism Insomnia Rating Scale (PAIRS)
Time frame: Baseline, Post-Intervention (Week 12), and Follow Up (Week 24)
The PAIRS is a parent rating of insomnia and sleep-related impairments over the past two weeks in children with ASD age 3 to 12 years. The PAIRS is a single-factor measure comprising 21 items that assess difficulties with falling and/or staying asleep, as well as the impact of sleep problems on the child and the family. Items are scored: 0 (mild = not present, not a problem) to 3 (severe = frequent and a major problem). Higher scores indicate greater severity.
6 secondary outcomes
Change in Child Sleep Dimensions Composite Score
Time frame: Baseline, Post-Intervention (Week 12)
Change in Child Daytime Behavior
Time frame: Baseline, Post-Intervention (Week 12), and Follow Up (Week 24)
Change in Child Health-Related Quality of Life
Time frame: Baseline, Post-Intervention (Week 12), and Follow Up (Week 24)
Change in Parental Stress
Time frame: Baseline, Post-Intervention (Week 12), and Follow Up (Week 24)
Change in Parental Sense of Competence
Time frame: Baseline, Post-Intervention (Week 12), and Follow Up (Week 24)
Change in Parental Sleep Quality
Time frame: Baseline and Post-Intervention (Week 12)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Megan L Wenzell, PhD principal investigator
Case Western Reserve University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified Sleep and Circadian Intervention in people with Sleep Disturbance and Autism Spectrum Disorder, run by Case Western Reserve University at 1 site in United States.
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 6 inclusion and 3 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: enrolling by invitation, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
This study is still under way. Results are not available in the source record yet.
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?
The Improvement Scale of the Clinical Global Impressions Scale (CGI-I) (time frame: Baseline, Post-Intervention (Week 12), and Follow Up (Week 24)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Sep 2026.