Parent-Mediated Teleheath Intervention for Insomnia in Young Autistic Children

Insomnia is a common complaint in young children with autism spectrum disorder (ASD, autism). Across a range from mild to severe, insomnia affects as many as 40-80% in this population.7, 9-11 Insomnia is characterized by problems of initiating sleep and/or maintaining sleep occurring three or more nights per week for > three months accompanied by distress, impairment or both.12 The diagnostic criteria stipulate that the sleep problem is not attributable to another cause. In autistic children, insomnia may interfere with concentration and learning, may contribute to daytime sleepiness, disruptive daytime behavior, emotion dysregulation and physical injury.13, 14 The child’s bedtime and sleep disturbances may also interfere with sleep for caregivers or other family members and predict elevated parental stress.15-20 Chronic insomnia in children may have detrimental effects on cardiovascular, endocrine or immune systems.21, 22 Parents of autistic children and insomnia consistently report bedtime resistance behaviors that may be difficult to manage. Accumulating data indicate that parent-mediated behavioral interventions for insomnia can be effective.23 To date, however, only a few randomized controlled trials have rigorously tested parent-mediated behavioral interventions for insomnia in autistic children.7, 24-27 Following on the results of our prior trial that delivered parent mediated treatment via telehealth4, we propose a large scale, multisite telehealth trial of a structured parent-mediated behavioral intervention for insomnia. This five-year, three-site telehealth randomized trial will evaluate a structured, parent-mediated behavioral intervention for insomnia compared to up-to-date parent education. Autistic children (N=180, ages > 3 to 7-11 months years, with moderate or greater insomnia will be randomly assigned to a structured, 5-session sleep parent mediated treatment (SPT) program delivered over 10 weeks or 5 sessions of sleep parent education (SPE) over 10 weeks. Assessments and treatments will be delivered via telehealth. In our recently completed telehealth trial, SPT was superior to SPE in improved child sleep outcomes, parental self-efficacy and parental distress.4 Although encouraging, the sample size of this recent study provided limited exploration of a number of variables and of treatment moderators. We now propose a large-scale definitive study of telehealth SPT versus individualized, menu-driven SPE. Pre-specified moderators include, arousal, anxiety, behavioral rigidity, sensory sensitivity. irritability, hyperactivity, and adaptive behavior. Examination of moderators will help answer “who” this intervention works for. Importantly, we will use a newly developed and validated outcome measure designed specifically for insomnia in young people with ASD. Children in the SPT group will be assessed at 20 weeks post-treatment to evaluate durability. Parents of children initially randomized to SPE will be offered SPT after the 10-week endpoint. A successful parent-mediated behavioral intervention for insomnia in young autistic children delivered via telehealth in the home could change the standard of care, change the course of long-term detrimental effects of insomnia for child and parents, and promote broader implementation. The time is right for this definitive trial. Project Number: 1R01HD114631-01A1 | Fiscal Year: 2025 | NIH Institute/Center: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Principal Investigator: CYNTHIA JOHNSON (+2 co-PIs) | Institution: CLEVELAND CLINIC LERNER COM-CWRU, CLEVELAND, OH | Award Amount: $668,178 | Activity Code: R01 | Study Section: Child Psychopathology and Developmental Disabilities Study Section[CPDD] View on NIH RePORTER: https://reporter.nih.gov/project-details/1R01HD11463101A1