Trial Outcomes & Findings for Telehealth Delivery of Treatment for Sleep Disturbances in Young Children With Autism Spectrum Disorder (NCT NCT03668873)

Last Updated: 2024-09-19

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

91 participants

Primary outcome timeframe

Baseline, 5 weeks, and 10 weeks

Results posted on

2024-09-19

Participant Flow

Recruitment began in November 2018 and the final participant was enrolled in August 2022.

140 children were pre-screened and 102 were found to be eligible for a full screen. Of those, 91 consented. There were 14 screen failures (4 whose CSI was less than 5, 7 whose ASD diagnosis could not be corroborated, and 3 who did not follow through with full screening). Leaving 77 participants to be randomized, data were available for 36 participants randomized to SPT and 38 participants to SPE after 2 drop out in SPT and 1 in SPE before the intervention was initiated.

Participant milestones

Participant milestones
Measure	Sleep Parent Training The five SPT sessions (each 60-90 minutes in duration) are individually delivered over 10-weeks. In addition to the five sessions, there are three home visits conducted via Express Care Online (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 Training: SPT provides a comprehensive intervention that teaches parents the basic concepts and practical skills to address an array of sleep problems.	Sleep Parent Education 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. Sleep Parent Education: SPE is a structured program intended to mimic competent treatment as usual. Thus, SPE is an accepted treatment and serves as an active comparator that controls for time and attention.
Overall Study STARTED	38	39
Overall Study COMPLETED	32	36
Overall Study NOT COMPLETED	6	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Sleep Parent Training The five SPT sessions (each 60-90 minutes in duration) are individually delivered over 10-weeks. In addition to the five sessions, there are three home visits conducted via Express Care Online (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 Training: SPT provides a comprehensive intervention that teaches parents the basic concepts and practical skills to address an array of sleep problems.	Sleep Parent Education 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. Sleep Parent Education: SPE is a structured program intended to mimic competent treatment as usual. Thus, SPE is an accepted treatment and serves as an active comparator that controls for time and attention.
Overall Study Lost to Follow-up	6	3

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sleep Parent Training n=36 Participants The five SPT sessions (each 60-90 minutes in duration) are individually delivered over 10-weeks. In addition to the five sessions, there are three home visits conducted via Express Care Online (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 Training: SPT provides a comprehensive intervention that teaches parents the basic concepts and practical skills to address an array of sleep problems.	Sleep Parent Education n=38 Participants 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. Sleep Parent Education: SPE is a structured program intended to mimic competent treatment as usual. Thus, SPE is an accepted treatment and serves as an active comparator that controls for time and attention.	Total n=74 Participants Total of all reporting groups
Age, Continuous	3.6 years STANDARD_DEVIATION 1.4 • n=5 Participants	3.8 years STANDARD_DEVIATION 1.4 • n=7 Participants	3.7 years STANDARD_DEVIATION 1.4 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	29 Participants n=5 Participants	33 Participants n=7 Participants	62 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	32 Participants n=5 Participants	32 Participants n=7 Participants	64 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) White	29 Participants n=5 Participants	24 Participants n=7 Participants	53 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	7 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Type of group educational activity the child attends, n (%)* Child Care only	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Type of group educational activity the child attends, n (%)* Public School	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Type of group educational activity the child attends, n (%)* Private School	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Type of group educational activity the child attends, n (%)* Special Education	13 Participants n=5 Participants	14 Participants n=7 Participants	27 Participants n=5 Participants
Type of group educational activity the child attends, n (%)* None	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Type of group educational activity the child attends, n (%)* Data Missing	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Child's usual living arrangement, n (%) Parental Home (At Least One Parent)	35 Participants n=5 Participants	37 Participants n=7 Participants	72 Participants n=5 Participants
Child's usual living arrangement, n (%) Relative (Other Than Parents)	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
In the current household, primary caregiver's highest level of education, n (%) High school graduate or GED	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
In the current household, primary caregiver's highest level of education, n (%) Some college or post-high school or 2yr degree	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
In the current household, primary caregiver's highest level of education, n (%) College Graduate	13 Participants n=5 Participants	9 Participants n=7 Participants	22 Participants n=5 Participants
In the current household, primary caregiver's highest level of education, n (%) Advanced graduate or professional degree	14 Participants n=5 Participants	21 Participants n=7 Participants	35 Participants n=5 Participants
Modified Simonds & Parraga Sleep Questionnaire-Composite Sleep Index (baseline), mean ± sd	7.6 units on a scale STANDARD_DEVIATION 2.2 • n=5 Participants	7.4 units on a scale STANDARD_DEVIATION 2.0 • n=7 Participants	7.5 units on a scale STANDARD_DEVIATION 2.1 • n=5 Participants
Clinical Global Impressions - Severity (baseline), mean ± sd	3.9 units on a scale STANDARD_DEVIATION .65 • n=5 Participants	4 units on a scale STANDARD_DEVIATION .75 • n=7 Participants	4 units on a scale STANDARD_DEVIATION 0.70 • n=5 Participants
Aberrant Behavior Checklist Subscale I (Irritability) (baseline), mean ± sd*	16 units on a scale STANDARD_DEVIATION 10 • n=5 Participants	13 units on a scale STANDARD_DEVIATION 7.8 • n=7 Participants	14 units on a scale STANDARD_DEVIATION 9.2 • n=5 Participants
Aberrant Behavior Checklist Subscale II (Social Withdraw) (baseline), mean ± sd*	14 units on a scale STANDARD_DEVIATION 8.5 • n=5 Participants	11 units on a scale STANDARD_DEVIATION 6.9 • n=7 Participants	13 units on a scale STANDARD_DEVIATION 7.9 • n=5 Participants
Aberrant Behavior Checklist Subscale III (Stereotypic Behavior) (baseline), mean ± sd*	7 units on a scale STANDARD_DEVIATION 5.1 • n=5 Participants	5.5 units on a scale STANDARD_DEVIATION 5.1 • n=7 Participants	6.2 units on a scale STANDARD_DEVIATION 5.1 • n=5 Participants
Aberrant Behavior Checklist Subscale IV (Hyperactivity/Noncompliance) (baseline), mean ± sd*	25 units on a scale STANDARD_DEVIATION 12 • n=5 Participants	22 units on a scale STANDARD_DEVIATION 12 • n=7 Participants	23 units on a scale STANDARD_DEVIATION 12 • n=5 Participants
Aberrant Behavior Checklist Subscale V (Inappropriate Speech) (baseline), mean ± sd*	3.1 units on a scale STANDARD_DEVIATION 2.8 • n=5 Participants	3 units on a scale STANDARD_DEVIATION 2.6 • n=7 Participants	3.1 units on a scale STANDARD_DEVIATION 2.7 • n=5 Participants
Children's ChronoType Questionnaire Morningness/Eveningness (M/E) scale score (baseline), mean ± sd*	26 units on a scale STANDARD_DEVIATION 7.1 • n=5 Participants	28 units on a scale STANDARD_DEVIATION 8.4 • n=7 Participants	27 units on a scale STANDARD_DEVIATION 7.8 • n=5 Participants
Parenting stress index-short form Defensive Responding (baseline), mean ± sd*	21 units on a scale STANDARD_DEVIATION 5.9 • n=5 Participants	20 units on a scale STANDARD_DEVIATION 7.4 • n=7 Participants	21 units on a scale STANDARD_DEVIATION 6.7 • n=5 Participants
Parental Stress Index Parental Distress (PD) (baseline), mean ± sd*	33 units on a scale STANDARD_DEVIATION 8.9 • n=5 Participants	33 units on a scale STANDARD_DEVIATION 11 • n=7 Participants	33 units on a scale STANDARD_DEVIATION 10 • n=5 Participants
Parental Stress Index Parent-Child Dysfunctional interaction (P-CDI) (baseline), mean ± sd*	34 units on a scale STANDARD_DEVIATION 7.1 • n=5 Participants	32 units on a scale STANDARD_DEVIATION 6.6 • n=7 Participants	33 units on a scale STANDARD_DEVIATION 6.9 • n=5 Participants
Parental Stress Index Difficult Child (DC) (baseline), mean ± sd*	43 units on a scale STANDARD_DEVIATION 6.2 • n=5 Participants	40 units on a scale STANDARD_DEVIATION 6.5 • n=7 Participants	41 units on a scale STANDARD_DEVIATION 6.4 • n=5 Participants
Parenting stress index-short form- Total Stress (baseline), mean ± sd*	111 units on a scale STANDARD_DEVIATION 16 • n=5 Participants	105 units on a scale STANDARD_DEVIATION 21 • n=7 Participants	108 units on a scale STANDARD_DEVIATION 19 • n=5 Participants
Parenting Sense of Competence Scale Total Score (baseline), mean ± sd*	72 units on a scale STANDARD_DEVIATION 11 • n=5 Participants	72 units on a scale STANDARD_DEVIATION 14 • n=7 Participants	72 units on a scale STANDARD_DEVIATION 13 • n=5 Participants
Patient Health Questionnaire Total Score (baseline), mean ± sd*	4 units on a scale STANDARD_DEVIATION 2.7 • n=5 Participants	4 units on a scale STANDARD_DEVIATION 3.5 • n=7 Participants	4 units on a scale STANDARD_DEVIATION 3.1 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 5 weeks, and 10 weeks

Population: 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.

Outcome measures

Outcome measures
Measure	Sleep Parent Training n=32 Participants The five SPT sessions (each 60-90 minutes in duration) are individually delivered over 10-weeks. In addition to the five sessions, there are three home visits conducted via Express Care Online (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 Training: SPT provides a comprehensive intervention that teaches parents the basic concepts and practical skills to address an array of sleep problems.	Sleep Parent Education n=33 Participants 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. Sleep Parent Education: SPE is a structured program intended to mimic competent treatment as usual. Thus, SPE is an accepted treatment and serves as an active comparator that controls for time and attention.
Change From Baseline on MSPSQ-CSI Week 5	-2.09 units on a scale Interval -3.05 to -1.12	-0.64 units on a scale Interval -1.24 to -0.04
Change From Baseline on MSPSQ-CSI Week 10	-3.31 units on a scale Interval -4.08 to -2.54	-1.46 units on a scale Interval -2.19 to -0.73

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Sleep Parent Training n=36 Participants The five SPT sessions (each 60-90 minutes in duration) are individually delivered over 10-weeks. In addition to the five sessions, there are three home visits conducted via Express Care Online (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 Training: SPT provides a comprehensive intervention that teaches parents the basic concepts and practical skills to address an array of sleep problems.	Sleep Parent Education n=38 Participants 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. Sleep Parent Education: SPE is a structured program intended to mimic competent treatment as usual. Thus, SPE is an accepted treatment and serves as an active comparator that controls for time and attention.
Percentage of Treatment Responders at Week 10 Using Clinical Global Impression (CGI-I) Scale	20 Participants	12 Participants

SECONDARY outcome

Timeframe: Baseline, 5 weeks, and 10 weeks

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

Outcome measures

Outcome measures
Measure	Sleep Parent Training n=31 Participants The five SPT sessions (each 60-90 minutes in duration) are individually delivered over 10-weeks. In addition to the five sessions, there are three home visits conducted via Express Care Online (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 Training: SPT provides a comprehensive intervention that teaches parents the basic concepts and practical skills to address an array of sleep problems.	Sleep Parent Education n=33 Participants 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. Sleep Parent Education: SPE is a structured program intended to mimic competent treatment as usual. Thus, SPE is an accepted treatment and serves as an active comparator that controls for time and attention.
Change in ABC- Irritability From Baseline week 5	-0.13 units on a scale Interval -2.28 to 2.01	-2.00 units on a scale Interval -3.29 to -0.7
Change in ABC- Irritability From Baseline week 10	-2.32 units on a scale Interval -4.29 to -0.36	-2.6 units on a scale Interval -3.78 to -1.43

SECONDARY outcome

Timeframe: baseline, 5 weeks, and 10 weeks

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

Outcome measures

Outcome measures
Measure	Sleep Parent Training n=30 Participants The five SPT sessions (each 60-90 minutes in duration) are individually delivered over 10-weeks. In addition to the five sessions, there are three home visits conducted via Express Care Online (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 Training: SPT provides a comprehensive intervention that teaches parents the basic concepts and practical skills to address an array of sleep problems.	Sleep Parent Education n=33 Participants 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. Sleep Parent Education: SPE is a structured program intended to mimic competent treatment as usual. Thus, SPE is an accepted treatment and serves as an active comparator that controls for time and attention.
Change in PSI From Baseline Week 5	-6.23 units on a scale Interval -10.38 to -2.07	-4.94 units on a scale Interval -9.88 to 0.0
Change in PSI From Baseline Week 10	-9.88 units on a scale Interval -15.05 to -4.72	-8.77 units on a scale Interval -14.22 to -3.33

SECONDARY outcome

Timeframe: Baseline, 5 week, 10 weeks

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.

Outcome measures

Outcome measures
Measure	Sleep Parent Training n=31 Participants The five SPT sessions (each 60-90 minutes in duration) are individually delivered over 10-weeks. In addition to the five sessions, there are three home visits conducted via Express Care Online (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 Training: SPT provides a comprehensive intervention that teaches parents the basic concepts and practical skills to address an array of sleep problems.	Sleep Parent Education n=32 Participants 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. Sleep Parent Education: SPE is a structured program intended to mimic competent treatment as usual. Thus, SPE is an accepted treatment and serves as an active comparator that controls for time and attention.
PSOC Change From Baseline Week 5	2.9 units on a scale Interval 0.81 to 4.99	-1.81 units on a scale Interval -4.41 to 0.78
PSOC Change From Baseline Week 10	3.96 units on a scale Interval 1.98 to 5.94	-0.68 units on a scale Interval -3.04 to 1.68

OTHER_PRE_SPECIFIED outcome

Timeframe: 10 weeks

Treatment fidelity checklists include the therapist integrity goals, parent objectives and level of adherence for each SPT and SPE session. Therapists rate themselves on 5-7 session-specific goals on a scale of 0 to 2 as follows: (0 = Goal was not achieved; 1 = Goal was partially achieved; 2 = Goal was fully achieved). Therapists are asked to comment on items rated 0. Parent objectives and adherence are scored on a similar scale. The score for each session = sum of scores for all items in that session divided by the total possible score X 100 (possible range 0-100%, higher score is better fidelity and adherence). The treatment fidelity checklists have been modeled after four other previously NIH-funded projects.

Outcome measures

Outcome measures
Measure	Sleep Parent Training n=36 Participants The five SPT sessions (each 60-90 minutes in duration) are individually delivered over 10-weeks. In addition to the five sessions, there are three home visits conducted via Express Care Online (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 Training: SPT provides a comprehensive intervention that teaches parents the basic concepts and practical skills to address an array of sleep problems.	Sleep Parent Education n=38 Participants 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. Sleep Parent Education: SPE is a structured program intended to mimic competent treatment as usual. Thus, SPE is an accepted treatment and serves as an active comparator that controls for time and attention.
Treatment Fidelity Treatment Integrity	98.05 percentage Interval 40.0 to 100.0	98.27 percentage Interval 66.6 to 100.0
Treatment Fidelity Parent Adherence	97.69 percentage Interval 60.0 to 100.0	99.15 percentage Interval 50.0 to 100.0

Adverse Events

Sleep Parent Training

Serious events: 1 serious events

Other events: 15 other events

Deaths: 0 deaths

Sleep Parent Education

Serious events: 1 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Sleep Parent Training n=32 participants at risk The five SPT sessions (each 60-90 minutes in duration) are individually delivered over 10-weeks. In addition to the five sessions, there are three home visits conducted via Express Care Online (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 Training: SPT provides a comprehensive intervention that teaches parents the basic concepts and practical skills to address an array of sleep problems.	Sleep Parent Education n=36 participants at risk 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. Sleep Parent Education: SPE is a structured program intended to mimic competent treatment as usual. Thus, SPE is an accepted treatment and serves as an active comparator that controls for time and attention.
Gastrointestinal disorders PICA event	3.1% 1/32 • Number of events 1 • Adverse events were collected at screening, baseline, week 5, week 10 and week 16. The Safety/Adverse Event Review Form also asked about the child's sleep, appetite and bowel habits. Reports of new adverse events or worsening of previously reported events were rated mild, moderate or severe. Hospitalization was documented as a serious adverse event. A "yes" answer to any of these queries prompted further questions to determine duration and severity. The onset, offset and severity of adverse events was documented whether presumed to be related to the study treatment or not.	2.8% 1/36 • Number of events 1 • Adverse events were collected at screening, baseline, week 5, week 10 and week 16. The Safety/Adverse Event Review Form also asked about the child's sleep, appetite and bowel habits. Reports of new adverse events or worsening of previously reported events were rated mild, moderate or severe. Hospitalization was documented as a serious adverse event. A "yes" answer to any of these queries prompted further questions to determine duration and severity. The onset, offset and severity of adverse events was documented whether presumed to be related to the study treatment or not.

Other adverse events

Other adverse events
Measure	Sleep Parent Training n=32 participants at risk The five SPT sessions (each 60-90 minutes in duration) are individually delivered over 10-weeks. In addition to the five sessions, there are three home visits conducted via Express Care Online (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 Training: SPT provides a comprehensive intervention that teaches parents the basic concepts and practical skills to address an array of sleep problems.	Sleep Parent Education n=36 participants at risk 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. Sleep Parent Education: SPE is a structured program intended to mimic competent treatment as usual. Thus, SPE is an accepted treatment and serves as an active comparator that controls for time and attention.
Infections and infestations cold or unknown virus	28.1% 9/32 • Adverse events were collected at screening, baseline, week 5, week 10 and week 16. The Safety/Adverse Event Review Form also asked about the child's sleep, appetite and bowel habits. Reports of new adverse events or worsening of previously reported events were rated mild, moderate or severe. Hospitalization was documented as a serious adverse event. A "yes" answer to any of these queries prompted further questions to determine duration and severity. The onset, offset and severity of adverse events was documented whether presumed to be related to the study treatment or not.	30.6% 11/36 • Adverse events were collected at screening, baseline, week 5, week 10 and week 16. The Safety/Adverse Event Review Form also asked about the child's sleep, appetite and bowel habits. Reports of new adverse events or worsening of previously reported events were rated mild, moderate or severe. Hospitalization was documented as a serious adverse event. A "yes" answer to any of these queries prompted further questions to determine duration and severity. The onset, offset and severity of adverse events was documented whether presumed to be related to the study treatment or not.
General disorders Tooth injury	6.2% 2/32 • Adverse events were collected at screening, baseline, week 5, week 10 and week 16. The Safety/Adverse Event Review Form also asked about the child's sleep, appetite and bowel habits. Reports of new adverse events or worsening of previously reported events were rated mild, moderate or severe. Hospitalization was documented as a serious adverse event. A "yes" answer to any of these queries prompted further questions to determine duration and severity. The onset, offset and severity of adverse events was documented whether presumed to be related to the study treatment or not.	2.8% 1/36 • Adverse events were collected at screening, baseline, week 5, week 10 and week 16. The Safety/Adverse Event Review Form also asked about the child's sleep, appetite and bowel habits. Reports of new adverse events or worsening of previously reported events were rated mild, moderate or severe. Hospitalization was documented as a serious adverse event. A "yes" answer to any of these queries prompted further questions to determine duration and severity. The onset, offset and severity of adverse events was documented whether presumed to be related to the study treatment or not.
Infections and infestations COVID-19	3.1% 1/32 • Adverse events were collected at screening, baseline, week 5, week 10 and week 16. The Safety/Adverse Event Review Form also asked about the child's sleep, appetite and bowel habits. Reports of new adverse events or worsening of previously reported events were rated mild, moderate or severe. Hospitalization was documented as a serious adverse event. A "yes" answer to any of these queries prompted further questions to determine duration and severity. The onset, offset and severity of adverse events was documented whether presumed to be related to the study treatment or not.	0.00% 0/36 • Adverse events were collected at screening, baseline, week 5, week 10 and week 16. The Safety/Adverse Event Review Form also asked about the child's sleep, appetite and bowel habits. Reports of new adverse events or worsening of previously reported events were rated mild, moderate or severe. Hospitalization was documented as a serious adverse event. A "yes" answer to any of these queries prompted further questions to determine duration and severity. The onset, offset and severity of adverse events was documented whether presumed to be related to the study treatment or not.
General disorders Constipation	6.2% 2/32 • Adverse events were collected at screening, baseline, week 5, week 10 and week 16. The Safety/Adverse Event Review Form also asked about the child's sleep, appetite and bowel habits. Reports of new adverse events or worsening of previously reported events were rated mild, moderate or severe. Hospitalization was documented as a serious adverse event. A "yes" answer to any of these queries prompted further questions to determine duration and severity. The onset, offset and severity of adverse events was documented whether presumed to be related to the study treatment or not.	2.8% 1/36 • Adverse events were collected at screening, baseline, week 5, week 10 and week 16. The Safety/Adverse Event Review Form also asked about the child's sleep, appetite and bowel habits. Reports of new adverse events or worsening of previously reported events were rated mild, moderate or severe. Hospitalization was documented as a serious adverse event. A "yes" answer to any of these queries prompted further questions to determine duration and severity. The onset, offset and severity of adverse events was documented whether presumed to be related to the study treatment or not.
Infections and infestations Ear Infection	3.1% 1/32 • Adverse events were collected at screening, baseline, week 5, week 10 and week 16. The Safety/Adverse Event Review Form also asked about the child's sleep, appetite and bowel habits. Reports of new adverse events or worsening of previously reported events were rated mild, moderate or severe. Hospitalization was documented as a serious adverse event. A "yes" answer to any of these queries prompted further questions to determine duration and severity. The onset, offset and severity of adverse events was documented whether presumed to be related to the study treatment or not.	5.6% 2/36 • Adverse events were collected at screening, baseline, week 5, week 10 and week 16. The Safety/Adverse Event Review Form also asked about the child's sleep, appetite and bowel habits. Reports of new adverse events or worsening of previously reported events were rated mild, moderate or severe. Hospitalization was documented as a serious adverse event. A "yes" answer to any of these queries prompted further questions to determine duration and severity. The onset, offset and severity of adverse events was documented whether presumed to be related to the study treatment or not.

Additional Information

Cynthia R. Johnson, PhD

Cleveland Clinic Foundation

Phone: 216 448-6440

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place