CBT for Insomnia in Children with Autism
(RECHArge Trial)
Recruiting in Palo Alto (17 mi)
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Missouri-Columbia
Must not be taking: Psychotropics, others
Disqualifiers: Other sleep disorders, Epilepsy, others
No Placebo Group
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial does not require stopping all medications, but if your child is taking stimulants, sleep medications, or melatonin, they must have been stable on these for at least 3 months before joining the trial.
What data supports the effectiveness of the treatment for insomnia in children with autism?
Research shows that Cognitive Behavioral Therapy for Childhood Insomnia (CBT-CI), whether delivered in-person or via telehealth, can improve sleep and reduce challenging behaviors in children with autism. Studies found that both children and their parents experienced better sleep and reduced fatigue, indicating that CBT-CI is a promising treatment for insomnia in this population.
12345Is Cognitive Behavioral Therapy for Insomnia safe for children with autism?
The studies suggest that Cognitive Behavioral Therapy for Insomnia (CBT-CI) is safe for children with autism, as it was well-received by parents and children, and no safety concerns were reported in the research.
12346How does the treatment for insomnia in children with autism differ from other treatments?
This treatment is unique because it uses Cognitive Behavioral Therapy (CBT) specifically adapted for children with autism, and it can be delivered remotely via telehealth, making it more accessible for families who may have difficulty attending in-person sessions. It not only improves sleep but also enhances daytime functioning and reduces challenging behaviors in children with autism.
12346Eligibility Criteria
This trial is for children aged 6-12 with Autism Spectrum Disorder and chronic insomnia, who have a verbal IQ of at least 70. Their parent or guardian must be able to read English at a 5th-grade level and live with the child. Kids on stable sleep-related meds can join, but those with untreated medical issues affecting sleep or taking certain other drugs cannot.Inclusion Criteria
My child has autism and trouble sleeping.
You have been diagnosed with autism spectrum disorder (ASD) in the past.
You need to have a verbal IQ of 70 or higher.
+7 more
Exclusion Criteria
I am not open to being randomly assigned to a treatment group.
I haven't started any new sleep or stimulant meds in the last month.
Any other health issues that could make it hard to take part in the trial.
+7 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2 weeks
1 visit (in-person)
Treatment
Participants undergo 4 sessions of behavioral therapy for sleep problems followed by 4 bimonthly booster sessions
8 weeks
4 visits (in-person or remote), 4 booster sessions (telephone)
Follow-up
Participants are monitored for sleep and secondary outcomes at 6-month and 12-month intervals
12 months
2 visits (in-person or remote)
Participant Groups
The study tests three ways to treat insomnia in kids with autism: in-person cognitive behavioral therapy (CBT), remote CBT, and remote sleep hygiene education (SHARE). It involves initial sessions followed by booster sessions, measuring outcomes like heart rate variability and changes in behavior.
3Treatment groups
Experimental Treatment
Group I: Remote behavioral SHARE for insomnia in children with autismExperimental Treatment1 Intervention
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.
Group II: Remote CBT for insomnia in children with autismExperimental Treatment1 Intervention
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.
Group III: In-person CBT for insomnia in children with autismExperimental Treatment1 Intervention
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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Thompson Center for Autism and Neurodevelopmental DisordersColumbia, MO
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Who Is Running the Clinical Trial?
University of Missouri-ColumbiaLead Sponsor
United States Department of DefenseCollaborator
References
Using Telehealth to Deliver Family-Based Cognitive Behavioral Treatment of Insomnia in a School-Aged Child With Autism Spectrum Disorder. [2022]Chronic insomnia (>3 months) is common in children with autism. Cognitive behavioral treatment for insomnia in children (CBT-CI) holds promise for improving sleep and daytime functioning in school-aged children with autism and their parents, but typical delivery involving multiple in-person office visits limits accessibility. This case study describes telehealth delivery of CBT-CI (teleCBT-CI) with a 7-year 4-month-old biracial boy with autism spectrum disorder (ASD) and insomnia and his parents. He and his mother wore actigraphs and completed electronic sleep diaries for 2 weeks, and his mother completed the Aberrant Behavior Checklist at pre/post/1-month follow-up. He and both of his parents completed eight telehealth treatment sessions. TeleCBT-CI improved the boy's sleep (objective, subjective) and decreased irritability, lethargy, stereotypy, and hyperactivity. This case study shows that teleCBT-CI is feasible and can improve child sleep and functioning.
Cognitive behavioral treatment of insomnia in school-aged children with autism spectrum disorder: A pilot feasibility study. [2020]Insomnia is common in autism and associated with challenging behavior and worse parent sleep. Cognitive behavioral treatment for childhood insomnia (CBT-CI) is efficacious in typically developing children, but not yet tested in school-aged children with autism. This single arm pilot tested 8-session CBT-CI in 17 children with autism and insomnia (M age = 8.76 years, SD = 1.99) and their parent(s) (M age = 39.50 years, SD = 4.83). Treatment integrity was assessed for each session [delivery (by therapist), receipt (participant understanding), and enactment (home practice)]. Children and parents wore actigraphs and completed electronic diaries for 2-weeks to obtain objective and subjective sleep onset latency (SOL), total sleep/wake times (TST/TWT), and sleep efficiency (SE) at pre/post/1-month follow-up. Parents also completed the Aberrant Behavior Checklist [irritability, lethargy, stereotypy, hyperactivity, inappropriate speech (e.g., excessive/repetitive, loud self-talk)] at pre/post/1-month. Fifteen children completed all sessions. Average integrity scores were high [90%-delivery/receipt, 87.5%-enactment]. Parents found CBT-CI helpful, age-appropriate, and autism-friendly. Paired samples t-tests (family-wise error controlled) found CBT-CI improved child sleep (objective SOL-18 min, TWT- 34 min, SE-5%; subjective SOL-29 min, TST-63 min, TWT-45 min, SE-8%), and decreased irritability, lethargy, stereotypy, and hyperactivity. At 1-month, objective TST improved, inappropriate speech decreased, but hyperactivity was no longer decreased. Other gains were maintained. Parent sleep (objective SOL-12 min, TST-35 min, TWT-21 min, SE-4%; subjective SOL-11 min, TWT- 31min, SE-11%) and fatigue also improved. At 1-month, gains were maintained. This pilot shows CBT-CI is a feasible treatment that holds promise for improving child and parent sleep and functioning and suggests a randomized controlled trial in school-aged children with autism is worth conducting. Autism Res 2020, 13: 167-176. © 2019 International Society for Autism Research, Wiley Periodicals, Inc. LAY SUMMARY: Insomnia is common in autism and associated with challenging behaviors and poor parent sleep and stress. Cognitive behavioral treatment for childhood insomnia (CBT-CI) has not been tested in school-aged children with autism. This pilot study shows therapists, parents, and children were able to use CBT-CI to improve child and parent sleep, child behavior, and parent fatigue. Parents found CBT-CI helpful, age-appropriate, and autism-friendly. CBT-CI holds promise for treating insomnia in school-aged children with autism and deserves further testing.
Telehealth cognitive behavioral therapy for insomnia in children with autism spectrum disorder: A pilot examining feasibility, satisfaction, and preliminary findings. [2021]Insomnia is common in children with autism. Cognitive behavioral treatment for childhood insomnia (CBT-CI) may improve sleep and functioning in children with autism and their parents, but typical delivery involving multiple office visits can make it difficult for some children to get this treatment. This pilot study tested telehealth delivery of CBT-CI using computers, which allowed children and their parents to get the treatment at home. This pilot shows therapists that parents and children were able to use telehealth CBT-CI to improve child and parent sleep, child behavior and arousal, and parent fatigue. Parents found telehealth CBT-CI helpful, age-appropriate, and autism-friendly. Telehealth CBT-CI holds promise for treating insomnia in school-aged children with autism and deserves further testing.
Protocol for targeting insomnia in school-aged children with autism spectrum disorder without intellectual disability: a randomised control trial. [2021]Insomnia affects up to 80% of children with autism spectrum disorder (ASD). Negative consequences of insomnia in ASD include decreased quality of life (QOL), impaired learning and cognition, increased stereotypic and challenging behaviours, and increased parental stress. Cognitive behavioural treatment for childhood insomnia (CBT-CI) is a promising treatment for dealing with insomnia and its negative consequences but has not yet been studied in school-aged children with ASD and comorbid insomnia. Access to healthcare is another challenge for children with ASD, particularly in rural and underserved regions. Previous studies indicate that ASD and insomnia share common arousal-based underpinnings, and we hypothesise that CBT-CI will reduce the hyperarousal associated with insomnia and ASD. This trial will be the first to examine CBT-CI adapted for children with ASD and will provide new information about two different modes of delivery across a variety of primary and secondary child and parent sleep and related outcomes. Knowledge obtained from this trial might allow us to develop new or modify current treatments to better target childhood insomnia and ASD.
Internet-delivered Cognitive Behavioral Therapy for insomnia in youth with autism spectrum disorder: A pilot study. [2022]Adolescents with ASD often suffer from sleep disorders affecting their development and quality of life. Research concerning psychological treatment of insomnia in this population is scarce. The objective of this pilot study was to examine the feasibility of internet-delivered CBT for insomnia (iCBT-I) and the participants' experiences after completing the treatment. Both quantitative and qualitative methods were used. Six adolescents with ASD and insomnia, aged 13 to 17, participated in the study. The results of the qualitative investigation showed general satisfaction with the iCBT-I. The participants experienced both better sleep and insights into their sleep patterns. Thematic analysis revealed five themes: experience of the structure of the treatment, treatment content, experienced outcomes, experienced difficulties, and suggested improvements. The results indicate the need for additional support for some participants and suggest distinct recommendations for further studies. The quantitative investigation showed large reductions in insomnia symptoms indicating the feasibility of the treatment in this population. The findings suggest promising results, but more studies are needed to define the efficacy of iCBT-I for adolescents with ASD.
Practice Tools for Screening and Monitoring Insomnia in Children and Adolescents with Autism Spectrum Disorder. [2022]Between 50-80% of children with autism spectrum disorder (ASD) have insomnia, which adversely affects their mental and physical health. However, there is no consensus to-date on suitable tools for insomnia screening and monitoring in daily clinical practice. An expert panel of child neuropsychiatry and sleep specialists, with expertise in children with neurodevelopmental disabilities, recommends: (1) performing insomnia screening of all children with ASD; (2) considering discussion or referral to a sleep specialist when comorbid sleep disorders are suspected. The panel further developed structured, brief screening and monitoring tools to facilitate insomnia screening and management in daily practice, monitor treatment effectiveness and standardize and compare outcomes across clinical settings to improve care and well-being of children with ASD and their families.