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CBT for Insomnia in Children with Autism (RECHArge Trial)

N/A
Recruiting
Led By Christina S McCrae, PhD
Research Sponsored by University of Missouri-Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Child diagnosed with ASD and insomnia
Age between 6 and 12 years
Must not have
Unwilling to accept random assignment
Parent unable to complete forms or implement treatment procedures due to cognitive impairment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24/7 during each 2 week assessment at 6 month follow up
Awards & highlights

Summary

This trial will study whether cognitive behavioral therapy (in-person or remote) can help children with ASD and insomnia, as well as their parent(s). Arousal will be measured through heart-rate variability and sleep and secondary outcomes (child daytime behavior, parent sleep) will be collected at different intervals.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since the interventions are non-pharmacological therapies focused on behavior modification and education, significant side effects are not expected. However, there may be minimal risks associated with discomfort from wearing monitoring devices during the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My child has autism and trouble sleeping.
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I am between 6 and 12 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not open to being randomly assigned to a treatment group.
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My parent cannot fill out forms or follow treatment plans due to cognitive issues.
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I am unable to give consent or my child cannot agree to participate.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24/7 during each 2 week assessment at 12 month follow up
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24/7 during each 2 week assessment at 12 month follow up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Baseline Average Bed/Waketime Variability for the child
Baseline Average Objective Sleep Efficiency for the child
Baseline Average Objective Total Sleep Time for the parent
+13 more
Secondary study objectives
Aberrant Behavior Checklist (ABC) for the child at 12 months
Aberrant Behavior Checklist (ABC) for the child at 6 months
Aberrant Behavior Checklist (ABC) for the child immediately after the intervention
+97 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Remote behavioral SHARE for insomnia in children with autismExperimental Treatment1 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 autismExperimental Treatment1 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 autismExperimental Treatment1 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.

Find a Location

Who is running the clinical trial?

University of Missouri-ColumbiaLead Sponsor
376 Previous Clinical Trials
628,481 Total Patients Enrolled
7 Trials studying Autism Spectrum Disorder
1,694 Patients Enrolled for Autism Spectrum Disorder
United States Department of DefenseFED
891 Previous Clinical Trials
332,298 Total Patients Enrolled
18 Trials studying Autism Spectrum Disorder
1,569 Patients Enrolled for Autism Spectrum Disorder
Christina S McCrae, PhDPrincipal InvestigatorUniversity of Missouri-Columbia
3 Previous Clinical Trials
281 Total Patients Enrolled

Media Library

In-Person CBT for insomnia in children with autism Clinical Trial Eligibility Overview. Trial Name: NCT04545606 — N/A
Autism Spectrum Disorder Research Study Groups: Remote CBT for insomnia in children with autism, Remote behavioral SHARE for insomnia in children with autism, In-person CBT for insomnia in children with autism
Autism Spectrum Disorder Clinical Trial 2023: In-Person CBT for insomnia in children with autism Highlights & Side Effects. Trial Name: NCT04545606 — N/A
In-Person CBT for insomnia in children with autism 2023 Treatment Timeline for Medical Study. Trial Name: NCT04545606 — N/A
~31 spots leftby Aug 2025
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