Sleep Restriction Therapy for Autism and Sleep Disorders

Overseen By Robin Libove, BS

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Severe psychiatric disorder, Epilepsy, others

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

Compensation: Varies

Number of Visits: 7

Duration: 3 weeks

25 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this open label trial is to examine the acceptability, tolerability, and feasibility and preliminary effectiveness of sleep restriction therapy for sleep problems in children with autism spectrum disorder (ASD). Treatment will be delivered via secure telemedicine platform and consist of parent-training in delivering the intervention.

Will I have to stop taking my current medications?

The trial requires that participants have stable medications for at least 2 weeks and no planned changes in their treatments during the study. So, you should not stop taking your current medications if they are stable.

What data supports the effectiveness of the treatment Sleep Restriction Therapy for Autism and Sleep Disorders?

Research shows that sleep restriction therapies can effectively improve insomnia in children by increasing evening sleepiness, which helps them fall asleep faster. This approach has been successful in reducing sleep onset latency (the time it takes to fall asleep) and improving overall sleep quality in children with chronic insomnia. ^{1 2 3 4 5}

Is Sleep Restriction Therapy safe for humans?

The research articles provided do not specifically address the safety of Sleep Restriction Therapy, but they do discuss the safety of related treatments like melatonin and cognitive-behavioral therapy for sleep issues in children with autism, which were found to be well-tolerated and safe. ^{1 2 3 6 7}

How does Sleep Restriction Therapy differ from other treatments for sleep disorders in children with autism?

Sleep Restriction Therapy is unique because it focuses on limiting the time spent in bed to increase sleep efficiency, which is different from other treatments like melatonin supplements or cognitive-behavioral therapy that aim to directly improve sleep onset and maintenance. This approach can help reset the body's internal clock and improve overall sleep quality. ^{1 2 3 8 9}

Research Team

Emma K Baker, MPsych(Clin), PhD

Principal Investigator

Stanford University

Eligibility Criteria

This trial is for children with Autism Spectrum Disorder (ASD) who are experiencing sleep problems. Parents will be trained to deliver the therapy via a secure telemedicine platform.

Inclusion Criteria

Stable on medications for at least 2 weeks

Diagnosed with autism spectrum disorder based on history and review of available medical records

I have been diagnosed with sleep problems.

Exclusion Criteria

My child currently has seizures or epilepsy.

Parent or child diagnosed with severe psychiatric disorder or unstable medical problem

Primary sleep disorder is a circadian rhythm sleep-wake disorder as determined by the sleep interview and Children's ChronoType Questionnaire.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive sleep restriction therapy delivered via telehealth sessions once per week for three weeks, with parent-training in delivering the intervention.

3 weeks

3 visits (virtual)

Follow-up

Participants implement sleep restriction therapy and are monitored for safety and effectiveness during a follow-up period.

4 weeks

4 weeks of monitoring

Treatment Details

Interventions

• Sleep Restriction Therapy

Trial Overview The study is testing Sleep Restriction Therapy (SRT) to see if it's acceptable, tolerable, and effective for improving sleep in children with ASD.

Participant Groups

Group I: Sleep Restriction Therapy Experimental Treatment 1 Intervention

Participants attend telehealth sessions once per week for three weeks and implement sleep restriction therapy in between sessions and for 4 weeks during a follow-up period.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Findings from Research

In a 14-week study involving 24 children with autism spectrum disorders, supplemental melatonin significantly improved sleep onset latency, showing effectiveness as early as the first week and maintaining benefits over several months.

The treatment was well tolerated and safe, leading to improvements not only in sleep but also in behavior and parenting stress, supporting the potential for larger randomized trials in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Melatonin for sleep in children with autism: a controlled trial examining dose, tolerability, and outcomes. Malow, B., Adkins, KW., McGrew, SG., 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]

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]

References

1. India pubmed.ncbi.nlm.nih.gov

Autism and sleep disorders. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Controlled-release melatonin, singly and combined with cognitive behavioural therapy, for persistent insomnia in children with autism spectrum disorders: a randomized placebo-controlled trial. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Melatonin for sleep in children with autism: a controlled trial examining dose, tolerability, and outcomes. [2022]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Sleep Disorders in Children and Adolescents with Autism Spectrum Disorder: Diagnosis, Epidemiology, and Management. [2021]

5. England pubmed.ncbi.nlm.nih.gov

A randomised controlled dismantling trial of sleep restriction therapies for chronic insomnia disorder in middle childhood: effects on sleep and anxiety, and possible contraindications. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Protocol for targeting insomnia in school-aged children with autism spectrum disorder without intellectual disability: a randomised control trial. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Randomised Controlled Trial of a Behavioural Sleep Intervention, 'Sleeping Sound', for Autistic Children: 12-Month Outcomes and Moderators of Treatment. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Cognitive behavioral treatment of insomnia in school-aged children with autism spectrum disorder: A pilot feasibility study. [2020]

9. Australia pubmed.ncbi.nlm.nih.gov

Behavioral and/or pharmacological interventions for managing sleep disturbances in children with autism spectrum disorder: an umbrella review protocol. [2019]