Columbia, MONCT04545606Now EnrollingIRB Ready

Insomnia Chronic Clinical Trial in Columbia, MO

Access cutting-edge insomnia chronic treatment through this clinical trial at a research site in Columbia. Study-provided care at no cost to qualified participants.

Sponsored by University of Missouri-Columbia

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Expert Care in Columbia

Access insomnia chronic specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related insomnia chronic treatment provided free

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Check if you qualify for this insomnia chronic clinical trial in Columbia, MO

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Columbia

    Convenient for MO residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Columbia site if eligible
  4. 4Begin participation

About This Insomnia Chronic Study in Columbia

Children with Autism Spectrum Disorder (ASD) and insomnia, and their parent(s) will undergo 4 sessions of behavioral therapy for sleep problems followed by 4 bimonthly booster sessions. Children and their families will be randomly assigned to one of three conditions: cognitive behavioral therapy (in-person), cognitive behavioral therapy (remote), or behavioral therapy (remote). Arousal will be measured through heart-rate variability. Sleep and secondary outcomes (child daytime behavior, parent sleep) will be collected at baseline (weeks 1-2 before starting the treatment), post-treatment (weeks 6-8 from baseline), 6-month follow-up, and 12-month follow-up.

Sponsor: University of Missouri-Columbia

Who Can Participate

Inclusion Criteria

1\) 6-12a yrs
2\) Verbal IQ \>= 70
3\) participation of child's parent or legal guardian living in the same home
4\) parent/guardian ability to read and understand English at the 5th-grade level
5\) child diagnosed with ASD and insomnia ASD:
1\) previous DSM diagnosis of ASD
2\) evaluation using gold-standard diagnostic tools (i.e., Autism Diagnostic Observation Schedule (ADOS) and/or Autism Diagnostic Interview-Revised \[ADI-R\]) Insomnia:
1\) complaints of difficulties falling asleep, staying asleep, or early morning awakening by child report or parent observation for 3+ mos
2\) daytime dysfunction (mood, cognitive, social, academic) due to insomnia
3\) baseline diaries and actigraphy indicate \>30 mins. of sleep onset latency, wake after sleep onset, or early morning awakening (time between last awakening and out of bed time) on 6+ nights

Exclusion Criteria

1\) parent unable to provide informed consent or child unable to provide assent
2\) unwilling to accept random assignment
3\) participation in another randomized research project
4\) parent unable to complete forms or implement treatment procedures due to cognitive impairment
5\) untreated medical comorbidity, including other sleep disorders (e.g., apnea, epilepsy, psychotic disorders, suicidal ideation/intent, \[frequent\] parasomnias)
6\) psychotropic or other medications that alter sleep with the exceptions of stimulants, sleep medications, and/or melatonin as described in #7 (see Notes below for details)
7\) stimulants, sleep medications (prescribed or OTC), and/or melatonin within the last 1 month (unless stabilized on medication for 3+ months)
8\) participation in non-pharmacological treatment (including CBT) for sleep outside current trial
9\) parent report of inability to undergo Holter Monitoring or actigraphy (e.g., extreme sensitivity, behavioral outbursts)
10\) other conditions adversely affecting trial participation

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Columbia?

Yes, this clinical trial (NCT04545606) has an active research site in Columbia, MO that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Insomnia Chronic Treatment Options in Columbia, MO

If you're searching for insomnia chronic treatment options in Columbia, MO, this clinical trial (NCT04545606) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Columbia research site is actively enrolling participants for this clinical trial. You'll receive care from experienced insomnia chronic specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all insomnia chronic clinical trials near you to find additional studies recruiting in your area.

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