Bedtime Routine for Autism

Overseen By Adriane M Soehner, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Disqualifiers: Non-English speakers, Trauma history, others

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

Compensation: Varies

Number of Visits: 3

Duration: 2 weeks

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new bedtime routine, "The Power Down," designed to help autistic children aged 6-10 settle down and fall asleep more easily. The researchers aim to determine if families find this routine easy to follow and helpful. The trial includes a two-week test period for the routine. Families with a child who has autism, struggles to fall asleep, and reacts strongly to sensory experiences may be a good fit. Participants must live in the Pittsburgh area and commit to the routine every night during the study. As an unphased study, this trial allows families to contribute to research that could enhance sleep routines for autistic children.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that this bedtime routine protocol is safe for autistic youth?

Research has shown that the "Power Down" routine is a new method designed to help autistic children prepare for sleep. As a behavioral approach rather than a medical treatment, specific safety data is not available. However, such strategies are generally considered safe because they do not involve medication or medical procedures.

The study is in its early stages and primarily assesses whether families find the routine easy to use and helpful. This suggests that any risks are likely very low. The main consideration is ensuring the routine is comfortable and not overwhelming for the children. Since this is not a drug-based treatment, typical side effects associated with medications are not expected. ^{1 2 3 4 5}

Why are researchers excited about this trial?

"Power Down" is unique because it focuses on creating a structured bedtime routine specifically tailored for individuals with autism. This approach differs from standard treatments, which often involve behavioral therapies or medications aimed at managing symptoms throughout the day. Researchers are excited about Power Down because it targets sleep issues, a common challenge in autism, by establishing consistent and calming pre-sleep activities. This non-pharmacological method offers a holistic way to improve sleep without relying on medication, potentially enhancing overall well-being and daily functioning.

What evidence suggests that the Power Down protocol is effective for improving bedtime routines in autistic youth?

Research has shown that sleep programs can help children with autism. For example, studies have found that bedtime routines, such as gradually moving bedtime earlier, can help children sleep longer and fall asleep faster. Better sleep for children also benefits parents by improving their sleep and emotional well-being. Additionally, online and telehealth sleep programs have helped children sleep more efficiently, meaning they spend more time actually sleeping when in bed. In this trial, all participants will engage in the "Power Down" pilot arm, a new method being tested. These findings suggest that structured bedtime routines can help children with autism relax and sleep better. ^{6 7 8 9 10}

Who Is on the Research Team?

Amy G Hartman, PhD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for autistic children aged 6-10 who have trouble settling down to sleep. It's designed to see if caregivers can use the 'Power Down' method every night and if families find it helpful.

Inclusion Criteria

My child is between 6 and 10 years old.

Parent-reported autism diagnosis for child

Parent-reported extended and problematic settling down delay

Exclusion Criteria

Participants will be excluded if they do not understand English or are unable to travel to University of Pittsburgh Medical Center Western Psychiatric Hospital

My child finds physical touch upsetting due to past trauma.

My child spends most nights at another home where the caregiver won't join this study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (virtual or phone call)

Training

Caregivers receive in-lab training on the Power Down protocol and practice with their child

1 day

1 visit (in-person)

Treatment

Caregivers perform the Power Down massage nightly for two weeks, completing morning and evening diaries

2 weeks

Daily virtual diary entries

Follow-up

Participants complete an exit interview and return the activity monitor

1 week

1 visit (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Power Down

Trial Overview

The study tests a new bedtime routine called 'Power Down.' Researchers want to know if it's easy for parents to follow and whether they think it works well for their kids with sleep issues.

How Is the Trial Designed?

Group I: Power Down pilot arm Experimental Treatment 1 Intervention

All participants will engage in a 2-week pilot intervention trial with baseline and post-intervention testing.

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

Published Research Related to This Trial

About two-thirds of children with autism spectrum disorder (ASD) experience chronic insomnia, highlighting a significant issue in this population.

Effective strategies for improving sleep in children with ASD include sleep education, environmental modifications, behavioral interventions, and the use of melatonin, as outlined in a practice pathway developed by the Autism Treatment Network.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep in Children with Autism Spectrum Disorder. Souders, MC., Zavodny, S., Eriksen, W., et al.[2022]

In a study of 93 children aged 6-12 years with autism spectrum disorder, nearly 40% were found to have sleep disorders, highlighting a significant prevalence of sleep issues in this population.

Insomnia was identified as the most common sleep disorder, affecting 25.8% of the children, indicating a critical area for further attention and potential intervention in managing autism spectrum disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep disturbances in children with autism spectrum disorder in Lahore, Pakistan; a cross-sectional study. Baig, U., Mehdi, SM., Imtiaz Afzal, HM.[2022]

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]

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]

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Autism & Safety Facts

Safety is a vital concern for families affected by autism. Find information here on Bullying, Restraint & Seclusion, Wandering, Sexual Abuse and more.