Recruiting

Insomnia

Sponsor:

University of Missouri-Columbia

Code:

NCT04545606

Conditions

Insomnia Chronic

Autism Spectrum Disorder

Eligibility Criteria

Sex: All

Age: 6 - 12

Healthy Volunteers: Not accepted

Interventions

In-Person CBT for insomnia in children with autism

Remote CBT for insomnia in children with autism

Remote sleep hygiene and related education (SHARE) for insomnia in children with autism

Study Details

Brief summary:

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.

Conditions

Insomnia Chronic

Autism Spectrum Disorder

Study ID

NCT04545606

Start date

Sep 15, 2020

Status verified date

Mar, 2024

Completion date

Aug, 2030

Anticipated

Primary completion date

Aug, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 12

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

180 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: In-person CBT for insomnia in children with autism

In-person cognitive-behavioral treatment (CBT) for insomnia in children with autism will be conducted at the Thompson Center. In-person treatment will consist of four 50-minute, individually administered sessions and four bi-monthly, 20-minute telephone boosters. Using a flexible, case conceptualization approach, the therapist will adapt the treatment to parent and child characteristics (i.e., verbal skills, development) and family situation/dynamics - promoting optimal efficacy and enhancing broad clinical applicability. Module administration order will be tailored to prioritize each child/family's most pressing sleep concerns based on the clinical interview.

experimental: Remote CBT for insomnia in children with autism

Remote/videoconferenced cognitive-behavioral treatment (CBT) for insomnia in children with autism will be conducted from home (families)/Thompson Center (therapist). Remote treatment will consist of four 50-minute, individually administered sessions and four bi-monthly, 20-minute telephone boosters. Using a flexible, case conceptualization approach, the therapist will adapt the treatment to parent and child characteristics (i.e., verbal skills, development) and family situation/dynamics - promoting optimal efficacy and enhancing broad clinical applicability. Module administration order will be tailored to prioritize each child/family's most pressing sleep concerns based on the clinical interview.

experimental: Remote behavioral SHARE for insomnia in children with autism

Remote/videoconferenced behavioral sleep hygiene and related education (SHARE) for insomnia in children with autism will be conducted from home (families)/Thompson Center (therapist). Remote treatment will consist of four 50-minute, individually administered sessions and four bi-monthly, 20-minute telephone boosters. Using a flexible, case conceptualization approach, the therapist will adapt the treatment to parent and child characteristics (i.e., verbal skills, development) and family situation/dynamics - promoting optimal efficacy and enhancing broad clinical applicability. Module administration order will be tailored to prioritize each child/family's most pressing sleep and related health related concerns/interests.

Interventions

In-Person CBT for insomnia in children with autism

7 modules administered in-person

1. Sleep Hygiene \& Sleep Prescription
2. Bedtime Routine \& Parent Management
3. Cue Control \& Parent Management
4. Co-Sleeping \& Parents Fading out of Room
5. Circadian Education, Morning Routine, \& Relaxation
6. Cognitive Therapy Basics
7. Nighttime Fears, Anxiety, \& Nightmares

Remote CBT for insomnia in children with autism

7 modules administered over telehealth/videoconferencing

1. Sleep Hygiene \& Sleep Prescription
2. Bedtime Routine \& Parent Management
3. Cue Control \& Parent Management
4. Co-Sleeping \& Parents Fading out of Room
5. Circadian Education, Morning Routine, \& Relaxation
6. Cognitive Therapy Basics
7. Nighttime Fears, Anxiety, \& Nightmares

Remote sleep hygiene and related education (SHARE) for insomnia in children with autism

7 modules administered over telehealth/videoconferencing

1. Sleep Education
2. Sleep Architecture \& Parasomnias
3. Physical Activity \& Sleep
4. Nutrition, My Plate, \& Breathing during Sleep
5. Stress, Sleep, Dreams, \& Nightmares Connections
6. Mood, Self-Esteem, \& Sleep
7. Light \& Dark Cycle

Primary outcome measure

  • Baseline Average Objective Sleep Efficiency for the child [ Time Frame: 24/7 during each 2 week assessment at Baseline ]
  • Change in Average Objective Sleep Efficiency for the child from baseline to immediately after the intervention [ Time Frame: 24/7 during each 2 week assessment immediately after the intervention ]
  • Change in Average Objective Sleep Efficiency for the child from baseline to 6 months [ Time Frame: 24/7 during each 2 week assessment at 6 month follow up ]
  • Change in Average Objective Sleep Efficiency for the child from baseline to 12 months [ Time Frame: 24/7 during each 2 week assessment at 12 month follow up ]
  • Baseline Average Bed/Waketime Variability for the child [ Time Frame: 24/7 during each 2 week assessment at Baseline ]
  • Change in Average Bed/Waketime Variability for the child from baseline to immediately after the intervention [ Time Frame: 24/7 during each 2 week assessment immediately after the intervention ]
  • Change in Average Bed/Waketime Variability for the child from baseline to 6 months [ Time Frame: 24/7 during each 2 week assessment at 6 month follow up ]
  • Change in Average Bed/Waketime Variability for the child from baseline to 12 months [ Time Frame: 24/7 during each 2 week assessment at 12 month follow up ]
  • Baseline Average RMSDNN (root mean squared st. dev. of N-N intervals) for the child [ Time Frame: 8 minute protocol during rest at Baseline (in clinic) ]
  • Change in Average RMSDNN (root mean squared st. dev. of N-N intervals) for the child from baseline to immediately after the intervention [ Time Frame: 8 minute protocol during rest immediately after the intervention (in clinic) ]
  • Change in Average RMSDNN (root mean squared st. dev. of N-N intervals) for the child from baseline to 6 months [ Time Frame: 8 minute protocol during rest at 6 month follow up (in clinic) ]
  • Change in Average RMSDNN (root mean squared st. dev. of N-N intervals) for the child from baseline to 12 months [ Time Frame: 8 minute protocol during rest at 12 month follow up (in clinic) ]
  • Baseline Average Objective Total Sleep Time for the parent [ Time Frame: 24/7 during each 2 week assessment at Baseline ]
  • Change in Average Objective Total Sleep Time for the parent from baseline to immediately after the intervention [ Time Frame: 24/7 during each 2 week assessment immediately after the intervention ]
  • Change in Average Objective Total Sleep Time for the parent from baseline to 6 months [ Time Frame: 24/7 during each 2 week assessment at 6 month follow up ]
  • Change in Average Objective Total Sleep Time for the parent from baseline to 12 months [ Time Frame: 24/7 during each 2 week assessment at 12 month follow up ]

Central Contacts and Locations

Central contacts

Melanie Stearns, PhD

859-327-7762mastearns@health.missouri.edu

Sydney Shoemaker, MS

573-882-5113sds3mk@health.missouri.edu

Locations

Thompson Center for Autism and Neurodevelopmental Disorders

Recruiting

Columbia, Missouri, United States, 65201

Contacts

Nicole Takahashi

573-884-1893TakahashiN@health.missouri.edu

More Information

Sponsor

University of Missouri-Columbia

Last update posted

Mar 15, 2024

Last verified

Mar, 2024

Keywords

  • cognitive behavioral therapy, behavioral therapy
  • children

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Missouri-Columbia on 2024-03-15.