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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up each morning for 2 weeks at baseline
Awards & highlights
RECHArge Trial 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.Check my eligibility
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.See study design
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.
RECHArge Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My child has autism and trouble sleeping.
Select...
I am between 6 and 12 years old.
RECHArge Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ each morning for 2 weeks immediately after the intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~each morning for 2 weeks immediately after the intervention
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 moreSecondary outcome measures
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 moreRECHArge 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.
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Who is running the clinical trial?
University of Missouri-ColumbiaLead Sponsor
362 Previous Clinical Trials
627,934 Total Patients Enrolled
7 Trials studying Autism Spectrum Disorder
1,694 Patients Enrolled for Autism Spectrum Disorder
United States Department of DefenseFED
865 Previous Clinical Trials
327,519 Total Patients Enrolled
18 Trials studying Autism Spectrum Disorder
1,560 Patients Enrolled for Autism Spectrum Disorder
Christina S McCrae, PhDPrincipal InvestigatorUniversity of Missouri-Columbia
3 Previous Clinical Trials
281 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not open to being randomly assigned to a treatment group.I haven't started any new sleep or stimulant meds in the last month.Any other health issues that could make it hard to take part in the trial.My child has autism and trouble sleeping.You have been diagnosed with autism spectrum disorder (ASD) in the past.A parent says that the child cannot do Holter Monitoring or actigraphy because of extreme sensitivity or behavioral outbursts.I am not currently in any non-drug sleep treatment programs.You need to have a verbal IQ of 70 or higher.You have been diagnosed using specific tests for autism.My parent cannot fill out forms or follow treatment plans due to cognitive issues.I do not have untreated medical issues like sleep disorders, epilepsy, or severe mental health conditions.I am not on medications that affect sleep, except for stimulants, sleep meds, or melatonin.I am between 6 and 12 years old.My child or I have had trouble sleeping for over 3 months.I am unable to give consent or my child cannot agree to participate.You have trouble with your mood, thinking, social activities, or school work because you can't sleep well at night.You have trouble falling asleep or staying asleep for more than 30 minutes on at least 6 nights.
Research Study Groups:
This trial has the following groups:- Group 1: Remote CBT for insomnia in children with autism
- Group 2: Remote behavioral SHARE for insomnia in children with autism
- Group 3: In-person CBT for insomnia in children with autism
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What key insights are being sought through this research endeavor?
"The primary metric that will be observed over the course of 2 weeks following the intervention is Baseline Average Bed/Waketime Variability for the child. As a secondary outcome, Child Quality of Life: PedsQL Parent Form (a 23-item scale with strong internal consistency and clinical validity) will be assessed by parents at baseline, post-intervention, and 6 months after treatment."
Answered by AI
How many individuals have been accepted into this research endeavor?
"Affirmative. According to the clinical trial's page on clinicaltrials.gov, this research endeavour is still gathering participants since its initial posting on September 15th 2020 and last update in March 16th 2022. A total of 180 individuals are needed for at least one specified medical facility."
Answered by AI
Can I partake in this medical experiment?
"This clinical trial is seeking 180 minors aged 6-12, who have been diagnosed with Autism Spectrum Disorder and insomnia. Other criteria include a minimum verbal IQ of 70, parental involvement of those living in the same home as the patient, and evidence of daytime dysfunction (affecting mood, cognition, socialisation or study) due to sleeplessness."
Answered by AI
Does this medical research require additional participants?
"Affirmative. Perusal of clinicaltrials.gov reveals that this medical study, first posted on September 15th 2020, is actively seeking candidates for enrolment. The trial requires 180 participants to be recruited from a single research centre."
Answered by AI
Does this clinical trial impose an age limitation, and if so what is the cutoff?
"According to the criteria set out by this study, it is only recruiting participants between 6 and 12 years old. There are 245 studies that focus on enrollees below 18 years of age and 202 studies focusing on older adults over 65."
Answered by AI
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