CBT for Insomnia in Children with Autism

(RECHArge Trial)

Overseen By Sydney Shoemaker, MS

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Missouri-Columbia

Must not be taking: Psychotropics, others

Disqualifiers: Other sleep disorders, Epilepsy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: 8 weeks

180 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways to help children with Autism Spectrum Disorder (ASD) who have trouble sleeping. Participants will receive either in-person cognitive behavioral therapy (CBT) for insomnia, remote CBT for insomnia, or remote sleep hygiene education to determine which method best improves sleep. The trial aims to assess how these treatments affect sleep and daily activities like mood and concentration. It is suitable for children aged 6-12 diagnosed with ASD who have experienced sleep issues for over three months, where these troubles also impact their daytime activities. As an unphased trial, this study offers a unique opportunity for participants to contribute to understanding effective sleep interventions for children with ASD.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Cognitive Behavioral Therapy (CBT) for insomnia is generally safe for children with autism, whether conducted in-person or online. Studies have found that both children and their parents consider these therapies helpful. In a small study, telehealth-delivered CBT allowed children to receive treatment at home, improving their sleep without major issues.

For the remote sleep hygiene and related education (SHARE) treatment, early evidence suggests it also helps children with autism sleep better. Although this treatment is newer and less studied, initial results are promising for both safety and effectiveness.

Overall, CBT methods, whether in-person or online, and sleep education like SHARE, show good results in helping children with autism sleep better, without major safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they offer new, flexible approaches to managing insomnia in children with autism. Unlike standard treatments like medication and general sleep hygiene advice, these cognitive-behavioral therapies (CBT) allow for personalization based on each child's verbal abilities and family dynamics. The remote delivery option is particularly distinctive, making it more accessible for families who may struggle to attend in-person sessions. By tailoring the treatment to specific sleep concerns and providing ongoing support with telephone boosters, these therapies aim to improve sleep more effectively and conveniently.

What evidence suggests that this trial's treatments could be effective for insomnia in children with autism?

Studies have shown that cognitive behavioral therapy (CBT) can effectively help children, including those with autism, sleep better. In this trial, participants will receive one of the following treatments: in-person CBT, remote CBT, or remote sleep hygiene education (SHARE). Research indicates that both in-person and online CBT for insomnia can improve sleep and reduce tiredness for children and their parents. Specifically, children with autism who received online CBT reported better sleep and behavior. Additionally, remote sleep hygiene education (SHARE) has shown promise in helping those with autism sleep better, with early studies showing positive results. Overall, these therapies are considered promising options for addressing insomnia in children with autism. ^{2 3 6 7 8}

Who Is on the Research Team?

Christina McCrae, PhD

Principal Investigator

University of Missouri-Columbia

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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

Trial Overview 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.

How Is the Trial Designed?

Group I: Remote behavioral SHARE for insomnia in children with autism Experimental Treatment 1 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 autism Experimental Treatment 1 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 autism Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

University of Missouri-Columbia

Lead Sponsor

Trials

387

Recruited

629,000+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Published Research Related to This Trial

Telehealth delivery of cognitive behavioral treatment for insomnia (teleCBT-CI) was successfully implemented for a 7-year-old boy with autism, showing improvements in both objective and subjective sleep measures.

The treatment also led to reductions in behavioral issues such as irritability, lethargy, stereotypy, and hyperactivity, indicating that teleCBT-CI can enhance overall functioning in children with autism and insomnia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using Telehealth to Deliver Family-Based Cognitive Behavioral Treatment of Insomnia in a School-Aged Child With Autism Spectrum Disorder. Davenport, MA., Berry, JR., Mazurek, MO., et al.[2022]

A pilot study involving 17 children with autism and insomnia showed that an 8-session cognitive behavioral treatment for childhood insomnia (CBT-CI) significantly improved both child and parent sleep, as well as reduced challenging behaviors like irritability and hyperactivity.

Parents reported that CBT-CI was helpful and suitable for their children, indicating that this treatment is feasible and promising for addressing insomnia in school-aged children with autism, warranting further research through randomized controlled trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive behavioral treatment of insomnia in school-aged children with autism spectrum disorder: A pilot feasibility study. McCrae, CS., Chan, WS., Curtis, AF., et al.[2020]

A pilot study involving six adolescents with Autism Spectrum Disorder (ASD) showed that internet-delivered cognitive behavioral therapy for insomnia (iCBT-I) was feasible and led to significant reductions in insomnia symptoms.

Participants reported general satisfaction with the treatment, improved sleep, and gained insights into their sleep patterns, highlighting the potential of iCBT-I as a beneficial intervention for insomnia in adolescents with ASD, though further research is needed to confirm its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-delivered Cognitive Behavioral Therapy for insomnia in youth with autism spectrum disorder: A pilot study. Georén, L., Jansson-Fröjmark, M., Nordenstam, L., et al.[2022]

A pilot study demonstrated that telehealth delivery of cognitive behavioral treatment for childhood insomnia (CBT-CI) effectively improved sleep and behavior in children with autism, as well as reducing parent fatigue.

Parents reported that the telehealth format was helpful, age-appropriate, and suitable for children with autism, suggesting that this method could increase access to treatment for insomnia in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telehealth cognitive behavioral therapy for insomnia in children with autism spectrum disorder: A pilot examining feasibility, satisfaction, and preliminary findings. McCrae, CS., Chan, WS., Curtis, AF., et al.[2021]

A significant percentage (50-80%) of children with autism spectrum disorder (ASD) experience insomnia, which negatively impacts their overall health, highlighting the need for effective screening tools.

An expert panel has recommended routine insomnia screening for all children with ASD and has developed structured tools to help clinicians monitor and manage insomnia, aiming to enhance treatment effectiveness and standardize care across different clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Practice Tools for Screening and Monitoring Insomnia in Children and Adolescents with Autism Spectrum Disorder. Banaschewski, T., Bruni, O., Fuentes, J., et al.[2022]

This study will be the first to evaluate cognitive behavioral treatment for childhood insomnia (CBT-CI) specifically adapted for children with autism spectrum disorder (ASD) and insomnia, involving 180 participants aged 6-12 years.

The trial aims to assess the effectiveness of CBT-CI in reducing insomnia and its negative impacts on children with ASD, with outcomes measured at multiple time points, including sleep quality, daytime functioning, and parental stress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protocol for targeting insomnia in school-aged children with autism spectrum disorder without intellectual disability: a randomised control trial. McCrae, CS., Mazurek, MO., Curtis, AF., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9149190/

Internet-delivered Cognitive Behavioral Therapy for ... In summary, most of the participants reported iCBT-I as having a good outcome, reporting better sleep after completing the treatment. One participant reported ...

2. withpower.com withpower.com/trial/phase-child-development-disorders-pervasive-8-2020-46964

CBT for Insomnia in Children with Autism (RECHArge Trial) 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 ...

3. bmjopen.bmj.com bmjopen.bmj.com/content/11/8/e045944

Protocol for targeting insomnia in school-aged children ... In a single arm pilot, in-person CBT-CI (n=17) conducted over 8 weeks of treatment improved both objective and subjective child total sleep and total wake time, ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1551714424002878

Protocol of a randomized controlled trial into guided ... In this randomized controlled trial, we will investigate the effectiveness of i-Sleep Autism, a guided, internet-delivered, cognitive behavioral intervention ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/jsr.70058

Effectiveness of Cognitive Behavioural Therapy for ... The present systematic review and narrative synthesis investigates the effectiveness of CBT-I in individuals with neurodevelopmental conditions.

6. academic.oup.com academic.oup.com/sleep/article-abstract/41/suppl_1/A298/4988844

0802 CBT for Insomnia in Children with Autism Spectrum ... In-person and remote CBT-CI-A improved sleep and daytime functioning in school-aged children with ASD and their parents. These findings indicate ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8388273/

Protocol for targeting insomnia in school-aged children ... 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.

8. researchgate.net researchgate.net/publication/336159026_Cognitive_behavioral_treatment_of_insomnia_in_school-aged_children_with_autism_spectrum_disorder_A_pilot_feasibility_study

Cognitive behavioral treatment of insomnia in school‐aged ... Cognitive behavioral treatment for childhood insomnia (CBT-CI) may improve sleep and functioning in children with autism and their parents, but ...