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

Trial Summary

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 data supports the effectiveness of the treatment Power Down for improving sleep in children with autism?

Research shows that parent-based sleep education workshops, which include establishing a bedtime routine, improve sleep habits and reduce sleep onset delay in children with autism. This suggests that structured bedtime routines, like Power Down, may help improve sleep in these children. ^{1 2 3 4 5}

Is the bedtime routine treatment safe for children with autism?

Research on supplemental melatonin, which is part of the bedtime routine treatment, shows it is generally safe and well-tolerated in children with autism. It has been used to improve sleep without significant safety concerns. ^{1 2 4 5 6}

How does the treatment 'Power Down' differ from other treatments for autism-related sleep issues?

The 'Power Down' treatment is unique because it focuses on establishing a bedtime routine specifically tailored for children with autism, which may include behavioral strategies and parental involvement, unlike other treatments that often rely on sleep education, environmental changes, or melatonin supplements. ^{1 2 3 4 7}

What is the purpose of this trial?

The goal of this pilot intervention study is to examine the feasibility and acceptability of a novel bedtime manipulation protocol called "The Power Down" for autistic youth, ages 6-10. The main questions it aims to answer are: 1. Is the Power Down feasible for caregivers to do each night? 2. Do the families find the Power Down an acceptable intervention to address their child's difficulties settling down to fall asleep?

Research Team

Amy G Hartman, PhD

Principal Investigator

University of Pittsburgh

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Neurobehavioral Associations with NREM and REM Sleep Architecture in Children with Autism Spectrum Disorder. [2022]

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

Sleep in Children with Autism Spectrum Disorder. [2022]

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

Parent-based sleep education workshops in autism. [2021]

4. Pakistan pubmed.ncbi.nlm.nih.gov

Sleep disturbances in children with autism spectrum disorder in Lahore, Pakistan; a cross-sectional study. [2022]

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

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

Practice Tools for Screening and Monitoring Insomnia in Children and Adolescents with Autism Spectrum Disorder. [2022]