Treatment to Improve Sleep in Caregivers With Insomnia and a Child With Autism

NCT05373537 | Active Not Recruiting

• 1 other identifier: 850797
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

Autism Spectrum Disorder (ASD) represents one of the most perplexing neurobiological disorders with a prevalence of 1 in 54 children. The lifelong challenging and disruptive behaviors often associated with ASD requires caregivers to change their behavior and modify their environments to provide an ecosystem for optimal outcomes for their child, family and themselves. ASD behaviors can have significant impact on caregivers mental health and family functioning, including the ability to develop and maintain healthy sleep routines. The caregiving population in US has a high prevalence of insomnia; two thirds of caregivers experiencing difficulties falling and/or staying asleep. The prevalence of insomnia in children with ASD is equally high, 60-80% experiencing night waking contributing to poor daytime behavior and disrupted sleep in the caregivers. This pilot RCT will focus on improving caregivers sleep in the context of caring for a child with ASD and insomnia with a multi-disciplinary team. The investigators will compare a home-based tailored CBT for Insomnia (CBT-I) versus a web-based Way to Health CBT-I intervention. This data will support a larger RCT with the Department of Defense funding opportunity through the Congressionally Directed Medical Research Program. This Autism Research Program focuses on improving lives of those living with ASD.

Conditions

Autism Spectrum Disorder; Insomnia Chronic; Caregiver Burden

Outcome Measures

Primary Outcomes (2)

• Caregiver Acceptability Opinion Survey

  Opinion Survey with 8 items rated on a 7- point Likert scale. minimum of 0 and max of 56 with a score of 40 or greater will be considered acceptable for this study.

  At week 8

• Feasibility of pilot study

  This study will be considered feasible if we obtain a 70% completion rate for the all measures.

  At week 8

Secondary Outcomes (10)

• Change in reported sleep on sleep diaries

  8 weeks

• Change in Caregiver behaviors

  week 8

• Change in Child Daytime behaviors

  week 8

• Change in total sleep time average measured by an actigraphy watch for caregiver

  week 8

• Change in sleep latency as measured by actigraphy watch for caregiver

  week 8

Study Arms (2)

Home-based

EXPERIMENTAL

home- based CBT-Insomnia intervention

Behavioral: Cognitive behavioral therapy for Insomnia

web-based

EXPERIMENTAL

web-based CBT-Insomnia intervention

Behavioral: Cognitive behavioral therapy for Insomnia

Interventions

Cognitive behavioral therapy for Insomnia BEHAVIORAL

Caregiver with insomnia will receive CBT-Insomnia and will be trained to implement CBT-I tailored for their child with Autism Spectrum Disorder and Insomnia

Home-based; web-based

Eligibility Criteria

• Age: 3 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Caregiver age 18 years or older
• Diagnosis of Insomnia
• Parental/guardian will give permission (informed consent) for child
• Telephone and web Access
• Stable medical and behavioral conditions, with no change in health status in the past three months
• Commitment to maintaining stable medication doses and keeping medication consistent
• Children age 3 to 17 years and one of their parents
• Diagnosis of Autism Spectrum Disorders, confirmed with Autism Diagnostic Observation Schedule and/or DSM-IV criteria.
• Diagnosis of Behavioral Insomnia or Insomnia due to ASD (Insomnia due to internal
• Parental/guardian permission (informed consent) and if appropriate, child assent.
• Telephone and web Access
• Stable medical and behavioral conditions, with no change in health status in the past
• Commitment to maintaining stable medication doses and keeping child's sleep medication consistent

You may not qualify if:

• Insomnia due to co-occurring medical conditions and/ or sleep disorders such as obstructive sleep apnea (OSA), narcolepsy, restless leg syndrome, severe reflux, nocturnal asthma
• Unstable co-occurring medical conditions such as epilepsy or other neurological disorders, sickle cell anemia, diabetes or severe eczema
• Significant hearing or vision loss
• Known genetic disorders such as Fragile X, 22ql 1.2 Deletion Syndrome, Rett Disorder, Down Syndrome.
• Subjects who, in the opinion of the Investigator, may be non¬ compliant with study schedules or procedures.

Sponsors & Collaborators

• University of Pennsylvania: lead
• Children's Hospital of Philadelphia: collaborator

Study Sites (2)

University of Pennsylvania

Philadelphia, Pennsylvania, 19041, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Sleep Initiation and Maintenance Disorders; Caregiver Burden

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Stress, Psychological; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pilot Randomized control trial Comparing a home-based vs a web-based approach to CBT-Insomnia

Study Record Dates

• First Submitted: April 11, 2022
• First Posted: May 13, 2022
• Study Start: November 5, 2022
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: starting 6 months after publications
• Access Criteria: The PIs will review requests for access

Locations

US (2)