Autism Spectrum DisorderNCT03668873

Telehealth Delivery of Treatment for Sleep Disturbances in Young Children With Autism Spectrum Disorder

A study testing Sleep Parent Training and Sleep Parent Education in people with Autism Spectrum Disorder and Sleep Disturbance, run by The Cleveland Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 2 to 7 years
Conditions the study is for: Autism Spectrum Disorder, Sleep Disturbance
What is being tested?: Sleep Parent Training and Sleep Parent Education
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 91 participants
Where: 1 siteUnited States
Study dates: 1 Nov 2018to 26 Dec 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 2 to 7 years
All sexes
No healthy volunteers
Child

Who may be able to join

Both genders >2 and <7 years of age
Clinical diagnosis of ASD corroborated by the Modified Checklist for Autism in Toddlers169 or the Social Communication Questionnaire.170
Score of >5 on the CSI and a Clinical Global Impression Severity (CGI-S) score of Moderate or greater.
Medication and supplement free or on stable medication or supplements (no changes in the past 6 weeks and no planned changes for 16 weeks).
Parental proficiency in spoken and written English language.

Who cannot join

Children with a serious medical condition or a known or suspected medical cause for sleep disturbances (e.g., nocturnal seizures, unresolved gastrointestinal problems such as reflux or constipation).
Children with a psychiatric disorder or serious behavioral problems requiring immediate treatment.
Children with known or suspected sleep apnea, restless legs, or periodic limb movements during sleep, or a circadian-based sleep disorder (e.g. delayed or advanced sleep phase syndrome) based on history and all available information.

Trial locations and contacts

1 site in 1 country.

United States1 site

Cleveland Clinic Centerl for Autism
Cleveland, Ohio, 44104

Other trials in United States

About this study

Study Design: Ninety children with Autism Spectrum Disorder (ASD), between the ages of 2 to less than 7 years, and their parents will be recruited for this 10 week randomized clinical trial. Participants will be randomized to five individually delivered sessions of Sleep Parent Training (SPT) or five individually delivered sessions of Sleep Parent Education (SPE). Delivery of the programs will be via telehealth platform which also includes parent-child coaching in real-time. In addition to baseline, outcome measures will be collected at week 5 (midpoint of trial) and week 10 (endpoint of trial) as well as follow-up at week 16 to determine durability of treatment.

Read the detailed description

This study will deliver an already initially tested manualized parent training program specially targeting bedtime and sleep disturbances, but delivered via telehealth platform and enhancing the program using live parent coaching at bedtime. Utilizing REDCap automated survey invitations feature, investigators will provide reminders of the intervention recommendations and data collection requirements. In a randomized clinical trial of 90 children with ASD, ages 2 to less than 7 years, a parent training program targeting sleep disturbance (Sleep Parent Training; SPT), will be compared to Sleep Parent Education (SPE). The investigators hypothesize that SPT will be superior in improving child sleep, child daytime functioning as well as parent well-being compared to SPE.

Specific Aims: Aim 1. To evaluate the efficacy of Sleep Parent Training program (SPT) delivered via telehealth for sleep disturbances compared Sleep Parent Educational Program (SPE, time and attention control) also delivered via telehealth in 90 children with ASD (ages >2 to <7 years) with moderate or greater sleep disturbances as measured by the Composite Sleep Index (CSI) of the modified Simonds and Parraga Sleep Questionnaire (MSPSQ).97 Aim 2. To evaluate the impact of SPT on child and parent quality of life (daytime child behavior, parental stress, parent sense of competency, mental health) compared to SPE.

Conditions: Autism Spectrum Disorder, Sleep Disturbance
Being tested: Sleep Parent Training, Sleep Parent Education
Keywords: Parent Training, Telehealth, Sleep Problems
Medical subject headings: Autism Spectrum Disorder, Parasomnias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Sleep Parent TrainingBehavioural
SPT provides a comprehensive intervention that teaches parents the basic concepts and practical skills to address an array of sleep problems.
Sleep Parent EducationBehavioural
SPE is a structured program intended to mimic treatment as usual. Thus, SPE is an accepted treatment and serves as an active comparator that controls for time and attention.

Study groups in NCT03668873
Study group	Role	What they receive
Sleep Parent Training	Experimental	The five SPT sessions (each 60-90 minutes in duration) are individually delivered over 10-week virtually (HIPAA compliant video-chat). After Session A, session order may be adjusted to address child-specific problems. One-on-one delivery of SPT permits flexibility for child-specific problems within the program. Receives: Behavioral: Sleep Parent Training
Sleep Parent Education	Active comparator	SPE consists of five 60-90 minute sessions, delivered individually over 10 weeks. SPE provides useful information to families of young children with ASD and sleep problems. Session A is designed to develop rapport. The sleep hygiene session (Session B) has been modeled from the RUBI manual. The other sessions include a systematic presentation on several relevant topics. An example of a SPE session is provided in the Intervention section. This condition is intended to parallel what would be offered in typical care, but by telehealth, where a parent might be educated about ASD as well as attend an outpatient appointment at a sleep clinic. Receives: Behavioral: Sleep Parent Education

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline on MSPSQ-CSI
Modified Simonds \& Parraga Sleep Questionnaire-Composite Sleep Index (MSPSQ - CSI). The modified version of the Simonds \& Parraga Sleep Questionnaire (MSPSQ6 was completed by the child's primary caregiver at baseline, and weeks 5 and 10 weeks for both groups. We used earlier described conventions for determining the MSPSQ - CSI score. The CSI was calculated by assigning a score to the frequency of sleep problems targeted: bedtime resistance (item 5), night waking (item 10), early waking (item 51) and sleeping in places other than bed (item 35). In addition, scores were assigned for the duration of sleep latency (item 6) and night wakings (item 12). Minimum score of 0 and maximum score of 12, higher score indicated worse outcome. The sample sizes reflect the number of participants who completed surveys at each follow-up.
Measured: Baseline, 5 weeks, and 10 weeks
Percentage of Treatment Responders at Week 10 Using Clinical Global Impression (CGI-I) Scale
Improvement scale of the Clinical Global Impression (CGI-I) Scale is a clinician-rated, 7-point scale designed to measure overall improvement from baseline. Scores range from 1 (Very Much Improved) to 4 (Unchanged) to 7 (Very Much Worse). An IE masked to group assignment used all available information to judge treatment response. CGI-I ratings of Much Improved (score of 2) or Very Much Improved (score of 1) were used to classify subjects as positive responders. All other scores classify subjects as negative responders. Subjects who dropped out or had missing data were classified as negative responders.
Measured: 10 weeks

Secondary outcomes (3)

Change in ABC- Irritability From Baseline
Aberrant Behavior Checklist. Each item is rated on a Likert scale from 0 (not a problem) to 3 (severe in degree)The ABC has shown adequate sensitivity to change in several pharmacological and behavioral treatment studies. The 15 item Irritability subscale has been used in other studies as a proxy for sleep-related impairment. Scores range from 0 to 45, higher score meaning a worse outcome. The sample sizes reflect the number of participants who completed surveys at each follow-up
Measured: Baseline, 5 weeks, and 10 weeks
Change in PSI From Baseline
This 36-item parent-completed questionnaire for children 12 years of age and younger and has three scales: 1) Parental Distress; 2) Difficult Child Characteristics; and, 3) Dysfunctional Parent-Child Interaction. This measure was developed from the PSI Full Form using factor analysis, and has been used to assess parental stress and parent-child relationships in children with autism and intellectual disabilities. Scores range from 36- 180. A total score of 88 (85th percentile) and above is considered in the clinically significant range for parental stress. The sample sizes reflect the number of participants who completed surveys at each follow-up
Measured: baseline, 5 weeks, and 10 weeks
PSOC Change From Baseline
This 17-item scale was developed to assess parental self-efficacy. Each item is answered on a 6-point scale ranging from strongly disagree to strongly agree. The PSOC also yields a Total Competence score ranging from 17 to 102 with higher scores reflecting higher competence.
Measured: Baseline, 5 week, 10 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Nov 201826 Dec 2022

First posted13 Sep 2018
Study start1 Nov 2018
Primary completion20 Nov 2022
Study completion26 Dec 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
More trials run by The Cleveland ClinicThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 91 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03668873
Sponsor's protocol ID: AR170155
Status last verified: May 2024
First submitted: 7 Sep 2018
Last updated: 19 Sep 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Shared in NDA

Publications

Johnson CR, Turner KS, Foldes E, Brooks MM, Kronk R, Wiggs L. Behavioral parent training to address sleep disturbances in young children with autism spectrum disorder: a pilot trial. Sleep Med. 2013 Oct;14(10):995-1004. doi: 10.1016/j.sleep.2013.05.013. Epub 2013 Aug 27.
PubMed 23993773
Johnson CR, Barto L, Worley S, Rothstein R, Alder ML. Telehealth parent training for sleep disturbances in young children with autism spectrum disorder: A randomized controlled trial. Sleep Med. 2023 Nov;111:208-219. doi: 10.1016/j.sleep.2023.08.033. Epub 2023 Sep 12.
PubMed 37806263

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Telehealth Delivery of Treatment for Sleep Disturbances in Young Children With Autism Spectrum Disorder
ClinicalTrials.gov ID: NCT03668873
Acronym / sponsor ID: AR170155
Conditions: Autism Spectrum Disorder, Sleep Disturbance
Keywords: Parent Training, Telehealth, Sleep Problems
Study type: Interventional
Recruitment status: Completed
Enrolment: 91 participants (actual)
Lead sponsor: The Cleveland ClinicUniversity, hospital or other
Collaborators: United States Department of Defense
Study start: 1 Nov 2018 (actual)
Primary completion: 20 Nov 2022 (actual)
Study completion: 26 Dec 2022 (actual)
First posted: 13 Sep 2018 (actual)
Results: Posted 19 Sep 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Sleep Parent Training	Experimental	Behavioral: Sleep Parent TrainingThe five SPT sessions (each 60-90 minutes in duration) are individually delivered over 10-week virtually (HIPAA compliant video-chat). After Session A, session order may be adjusted to address child-specific problems. One-on-one delivery of SPT permits flexibility for child-specific problems within the program.
Sleep Parent Education	Active comparator	Behavioral: Sleep Parent EducationSPE consists of five 60-90 minute sessions, delivered individually over 10 weeks. SPE provides useful information to families of young children with ASD and sleep problems. Session A is designed to develop rapport. The sleep hygiene session (Session B) has been modeled from the RUBI manual. The other sessions include a systematic presentation on several relevant topics. An example of a SPE session is provided in the Intervention section. This condition is intended to parallel what would be offered in typical care, but by telehealth, where a parent might be educated about ASD as well as attend an outpatient appointment at a sleep clinic.

Who may qualify

Ages: 2 to 7 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (5 listed)

Both genders >2 and <7 years of age
Clinical diagnosis of ASD corroborated by the Modified Checklist for Autism in Toddlers169 or the Social Communication Questionnaire.170
Score of >5 on the CSI and a Clinical Global Impression Severity (CGI-S) score of Moderate or greater.
Medication and supplement free or on stable medication or supplements (no changes in the past 6 weeks and no planned changes for 16 weeks).
Parental proficiency in spoken and written English language.

Key exclusion criteria (3 listed)

Children with a serious medical condition or a known or suspected medical cause for sleep disturbances (e.g., nocturnal seizures, unresolved gastrointestinal problems such as reflux or constipation).
Children with a psychiatric disorder or serious behavioral problems requiring immediate treatment.
Children with known or suspected sleep apnea, restless legs, or periodic limb movements during sleep, or a circadian-based sleep disorder (e.g. delayed or advanced sleep phase syndrome) based on history and all available information.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Sleep Parent TrainingSPT provides a comprehensive intervention that teaches parents the basic concepts and practical skills to address an array of sleep problems.	Behavioural	Sleep Parent Training
Sleep Parent EducationSPE is a structured program intended to mimic treatment as usual. Thus, SPE is an accepted treatment and serves as an active comparator that controls for time and attention.	Behavioural	Sleep Parent Education

Primary outcome

Change From Baseline on MSPSQ-CSI
Time frame: Baseline, 5 weeks, and 10 weeks
Modified Simonds \& Parraga Sleep Questionnaire-Composite Sleep Index (MSPSQ - CSI). The modified version of the Simonds \& Parraga Sleep Questionnaire (MSPSQ6 was completed by the child's primary caregiver at baseline, and weeks 5 and 10 weeks for both groups. We used earlier described conventions for determining the MSPSQ - CSI score. The CSI was calculated by assigning a score to the frequency of sleep problems targeted: bedtime resistance (item 5), night waking (item 10), early waking (item 51) and sleeping in places other than bed (item 35). In addition, scores were assigned for the duration of sleep latency (item 6) and night wakings (item 12). Minimum score of 0 and maximum score of 12, higher score indicated worse outcome. The sample sizes reflect the number of participants who completed surveys at each follow-up.
Percentage of Treatment Responders at Week 10 Using Clinical Global Impression (CGI-I) Scale
Time frame: 10 weeks
Improvement scale of the Clinical Global Impression (CGI-I) Scale is a clinician-rated, 7-point scale designed to measure overall improvement from baseline. Scores range from 1 (Very Much Improved) to 4 (Unchanged) to 7 (Very Much Worse). An IE masked to group assignment used all available information to judge treatment response. CGI-I ratings of Much Improved (score of 2) or Very Much Improved (score of 1) were used to classify subjects as positive responders. All other scores classify subjects as negative responders. Subjects who dropped out or had missing data were classified as negative responders.

3 secondary outcomes

Change in ABC- Irritability From Baseline
Time frame: Baseline, 5 weeks, and 10 weeks
Change in PSI From Baseline
Time frame: baseline, 5 weeks, and 10 weeks
PSOC Change From Baseline
Time frame: Baseline, 5 week, 10 weeks

Results and safety

Results posted to the registry on 19 Sep 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sleep Parent Training	38	32
Sleep Parent Education	39	36

Primary outcome: Change From Baseline on MSPSQ-CSI

Time frame: Baseline, 5 weeks, and 10 weeks. Least squares mean (95% Confidence Interval). Unit: units on a scale

Measure	Sleep Parent Training n = 32	Sleep Parent Education n = 33
Week 5	-2.09 (-3.05 to -1.12)	-0.64 (-1.24 to -0.04)
Week 10	-3.31 (-4.08 to -2.54)	-1.46 (-2.19 to -0.73)

Sleep Parent Training vs Sleep Parent Education: Difference of Least Squares Means: -1.85 (95% CI -2.88 to -0.81), p <0.001, Mixed Models Analysis

Population analysed: A modified intention-to-treat principle was used for the primary analysis, in which participants who attended at least one treatment session were analyzed in the group to which they were randomized.

Primary outcome: Percentage of Treatment Responders at Week 10 Using Clinical Global Impression (CGI-I) Scale

Time frame: 10 weeks. Count of participants. Unit: Participants

Measure	Sleep Parent Training n = 36	Sleep Parent Education n = 38
Value	20	12

Sleep Parent Training vs Sleep Parent Education: Absolute percent difference: 24 (95% CI 2 to 46), p = 0.037, Chi-squared

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected at screening, baseline, week 5, week 10 and week 16.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sleep Parent Training	1 of 32 (3.1%)	15 of 32 (46.9%)	0 of 32
Sleep Parent Education	1 of 36 (2.8%)	14 of 36 (38.9%)	0 of 36

Limitations and caveats (from the sponsor): In designing the trial for telehealth delivery, we did not include some measures we might have if the study was in-person. For example, we did not have cognitive or language measures. These could also be treatment moderators in a larger study. We also did not include a measure of anxiety which is a likely predictive for treatment response. Further absent were measures of repetitive / restrictive behaviors or sensory sensitivities; both domains may influence response to the intervention.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 23993773Johnson CR, Turner KS, Foldes E, Brooks MM, Kronk R, Wiggs L. Behavioral parent training to address sleep disturbances in young children with autism spectrum disorder: a pilot trial. Sleep Med. 2013 Oct;14(10):995-1004. doi: 10.1016/j.sleep.2013.05.013. Epub 2013 Aug 27.
Results publication: PubMed 37806263Johnson CR, Barto L, Worley S, Rothstein R, Alder ML. Telehealth parent training for sleep disturbances in young children with autism spectrum disorder: A randomized controlled trial. Sleep Med. 2023 Nov;111:208-219. doi: 10.1016/j.sleep.2023.08.033. Epub 2023 Sep 12.
Individual participant dataSharing planned: No. Shared in NDA

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Cynthia R Johnson, PhD principal investigator

The Cleveland Clinic

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Sleep Parent Training and Sleep Parent Education in people with Autism Spectrum Disorder and Sleep Disturbance, run by The Cleveland Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline on MSPSQ-CSI (time frame: Baseline, 5 weeks, and 10 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03668873, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.