Targeting Insomnia in School Aged Children With Autism Spectrum Disorder

Part of paid clinical trials in Columbia, Missouri.

Sponsor
University of Missouri-Columbia
Study ID
NCT04545606
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
6 Years - 12 Years
Healthy Volunteers
Not accepted

Interventions

  • In-Person CBT for insomnia in children with autism — BEHAVIORAL
    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 — BEHAVIORAL
    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 — BEHAVIORAL
    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

Study Details

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.

Key Dates

Start date
Sep 15, 2020
Status verified
Mar 2024
Primary completion
Aug 31, 2025
Completion
Aug 31, 2030

Study Design

Enrollment
180 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Baseline Average Objective Sleep Efficiency for the child [ Time Frame: 24/7 during each 2 week assessment at Baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Thompson Center for Autism and Neurodevelopmental DisordersColumbiaMissouri65201
Nicole Takahashi
[email protected]
573-884-1893

Find similar trials in Columbia, MO

By condition
Autism spectrum disorder
By specialty
Pediatrics
By research site
Thompson Center for Autism and Neurodevelopmental Disorders· Columbia, MO

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