Autism Spectrum Disorder, Sleep Disturbance
Conditions
Keywords
Parent Training, Telehealth, Sleep Problems
Brief summary
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.
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.
Interventions
BEHAVIORALSleep Parent Training
SPT provides a comprehensive intervention that teaches parents the basic concepts and practical skills to address an array of sleep problems.
BEHAVIORALSleep Parent Education
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.
Sponsors
United States Department of Defense
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to 7 Years
Healthy volunteers
No
Inclusion criteria
1. Both genders \>2 and \<7 years of age 2. Clinical diagnosis of ASD corroborated by the Modified Checklist for Autism in Toddlers169 or the Social Communication Questionnaire.170 3. Score of \>5 on the CSI and a Clinical Global Impression Severity (CGI-S) score of Moderate or greater. 4. Medication and supplement free or on stable medication or supplements (no changes in the past 6 weeks and no planned changes for 16 weeks). 5. Parental proficiency in spoken and written English language.
Exclusion criteria
1. 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). 2. Children with a psychiatric disorder or serious behavioral problems requiring immediate treatment. 3. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline on MSPSQ-CSI | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in ABC- Irritability From Baseline | 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 |
| Change in PSI From Baseline | 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 |
| PSOC Change From Baseline | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Treatment Fidelity | 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. |
Countries
United States
Participant flow
Recruitment details
Recruitment began in November 2018 and the final participant was enrolled in August 2022.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 36 |
| 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. | 38 |
| Total | 74 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 6 | 3 |
Baseline characteristics
| Characteristic | Total | Sleep Parent Education | Sleep Parent Training |
|---|---|---|---|
| Aberrant Behavior Checklist Subscale III (Stereotypic Behavior) (baseline), mean ± sd* | 6.2 units on a scale STANDARD_DEVIATION 5.1 | 5.5 units on a scale STANDARD_DEVIATION 5.1 | 7 units on a scale STANDARD_DEVIATION 5.1 |
| Aberrant Behavior Checklist Subscale I (Irritability) (baseline), mean ± sd* | 14 units on a scale STANDARD_DEVIATION 9.2 | 13 units on a scale STANDARD_DEVIATION 7.8 | 16 units on a scale STANDARD_DEVIATION 10 |
| Aberrant Behavior Checklist Subscale II (Social Withdraw) (baseline), mean ± sd* | 13 units on a scale STANDARD_DEVIATION 7.9 | 11 units on a scale STANDARD_DEVIATION 6.9 | 14 units on a scale STANDARD_DEVIATION 8.5 |
| Aberrant Behavior Checklist Subscale IV (Hyperactivity/Noncompliance) (baseline), mean ± sd* | 23 units on a scale STANDARD_DEVIATION 12 | 22 units on a scale STANDARD_DEVIATION 12 | 25 units on a scale STANDARD_DEVIATION 12 |
| Aberrant Behavior Checklist Subscale V (Inappropriate Speech) (baseline), mean ± sd* | 3.1 units on a scale STANDARD_DEVIATION 2.7 | 3 units on a scale STANDARD_DEVIATION 2.6 | 3.1 units on a scale STANDARD_DEVIATION 2.8 |
| Age, Continuous | 3.7 years STANDARD_DEVIATION 1.4 | 3.8 years STANDARD_DEVIATION 1.4 | 3.6 years STANDARD_DEVIATION 1.4 |
| Children's ChronoType Questionnaire Morningness/Eveningness (M/E) scale score (baseline), mean ± sd* | 27 units on a scale STANDARD_DEVIATION 7.8 | 28 units on a scale STANDARD_DEVIATION 8.4 | 26 units on a scale STANDARD_DEVIATION 7.1 |
| Child's usual living arrangement, n (%) Parental Home (At Least One Parent) | 72 Participants | 37 Participants | 35 Participants |
| Child's usual living arrangement, n (%) Relative (Other Than Parents) | 2 Participants | 1 Participants | 1 Participants |
| Clinical Global Impressions - Severity (baseline), mean ± sd | 4 units on a scale STANDARD_DEVIATION 0.7 | 4 units on a scale STANDARD_DEVIATION 0.75 | 3.9 units on a scale STANDARD_DEVIATION 0.65 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants | 6 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 64 Participants | 32 Participants | 32 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| In the current household, primary caregiver's highest level of education, n (%) Advanced graduate or professional degree | 35 Participants | 21 Participants | 14 Participants |
| In the current household, primary caregiver's highest level of education, n (%) College Graduate | 22 Participants | 9 Participants | 13 Participants |
| In the current household, primary caregiver's highest level of education, n (%) High school graduate or GED | 8 Participants | 4 Participants | 4 Participants |
| In the current household, primary caregiver's highest level of education, n (%) Some college or post-high school or 2yr degree | 9 Participants | 4 Participants | 5 Participants |
| Modified Simonds & Parraga Sleep Questionnaire-Composite Sleep Index (baseline), mean ± sd | 7.5 units on a scale STANDARD_DEVIATION 2.1 | 7.4 units on a scale STANDARD_DEVIATION 2 | 7.6 units on a scale STANDARD_DEVIATION 2.2 |
| Parental Stress Index Difficult Child (DC) (baseline), mean ± sd* | 41 units on a scale STANDARD_DEVIATION 6.4 | 40 units on a scale STANDARD_DEVIATION 6.5 | 43 units on a scale STANDARD_DEVIATION 6.2 |
| Parental Stress Index Parental Distress (PD) (baseline), mean ± sd* | 33 units on a scale STANDARD_DEVIATION 10 | 33 units on a scale STANDARD_DEVIATION 11 | 33 units on a scale STANDARD_DEVIATION 8.9 |
| Parental Stress Index Parent-Child Dysfunctional interaction (P-CDI) (baseline), mean ± sd* | 33 units on a scale STANDARD_DEVIATION 6.9 | 32 units on a scale STANDARD_DEVIATION 6.6 | 34 units on a scale STANDARD_DEVIATION 7.1 |
| Parenting Sense of Competence Scale Total Score (baseline), mean ± sd* | 72 units on a scale STANDARD_DEVIATION 13 | 72 units on a scale STANDARD_DEVIATION 14 | 72 units on a scale STANDARD_DEVIATION 11 |
| Parenting stress index-short form Defensive Responding (baseline), mean ± sd* | 21 units on a scale STANDARD_DEVIATION 6.7 | 20 units on a scale STANDARD_DEVIATION 7.4 | 21 units on a scale STANDARD_DEVIATION 5.9 |
| Parenting stress index-short form- Total Stress (baseline), mean ± sd* | 108 units on a scale STANDARD_DEVIATION 19 | 105 units on a scale STANDARD_DEVIATION 21 | 111 units on a scale STANDARD_DEVIATION 16 |
| Patient Health Questionnaire Total Score (baseline), mean ± sd* | 4 units on a scale STANDARD_DEVIATION 3.1 | 4 units on a scale STANDARD_DEVIATION 3.5 | 4 units on a scale STANDARD_DEVIATION 2.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 5 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 9 Participants | 7 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 53 Participants | 24 Participants | 29 Participants |
| Sex: Female, Male Female | 12 Participants | 5 Participants | 7 Participants |
| Sex: Female, Male Male | 62 Participants | 33 Participants | 29 Participants |
| Type of group educational activity the child attends, n (%)* Child Care only | 6 Participants | 4 Participants | 2 Participants |
| Type of group educational activity the child attends, n (%)* Data Missing | 1 Participants | 1 Participants | 0 Participants |
| Type of group educational activity the child attends, n (%)* None | 18 Participants | 9 Participants | 9 Participants |
| Type of group educational activity the child attends, n (%)* Private School | 8 Participants | 3 Participants | 5 Participants |
| Type of group educational activity the child attends, n (%)* Public School | 14 Participants | 7 Participants | 7 Participants |
| Type of group educational activity the child attends, n (%)* Special Education | 27 Participants | 14 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 32 | 0 / 36 |
| other Total, other adverse events | 15 / 32 | 14 / 36 |
| serious Total, serious adverse events | 1 / 32 | 1 / 36 |
Outcome results
Primary
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.
Time frame: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Sleep Parent Training | Change From Baseline on MSPSQ-CSI | Week 5 | -2.09 units on a scale |
| Sleep Parent Training | Change From Baseline on MSPSQ-CSI | Week 10 | -3.31 units on a scale |
| Sleep Parent Education | Change From Baseline on MSPSQ-CSI | Week 5 | -0.64 units on a scale |
| Sleep Parent Education | Change From Baseline on MSPSQ-CSI | Week 10 | -1.46 units on a scale |
Comparison: The null hypothesis was that the SPE and SPT groups did not differ on change in CSI score at 10 weeks. Assuming a standard deviation of 2.5 units and an attrition rate of 10%, an enrollment target of 90 participants would provide 90% power to detect a difference of 1.85 points or greater with a type I error rate of 0.05 using a two-tailed two-sample t-test.p-value: <0.00195% CI: [-2.88, -0.81]Mixed Models Analysis
Primary
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sleep Parent Training | Percentage of Treatment Responders at Week 10 Using Clinical Global Impression (CGI-I) Scale | 20 Participants |
| Sleep Parent Education | Percentage of Treatment Responders at Week 10 Using Clinical Global Impression (CGI-I) Scale | 12 Participants |
Comparison: The null hypothesis was that the SPE and SPT groups did not differ on the rate of positive response to CGI-I at 10 weeks. Assuming a 25%-40% positive response rate at 10 weeks in the SPE group and 45 patients per group, power was 90% to detect a 32% or greater difference in positive response rate (57%-72% in SPT group, respectively), with a type I error rate of 0.05 using a Chi-square test.p-value: 0.03795% CI: [2, 46]Chi-squared
Secondary
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
Time frame: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Sleep Parent Training | Change in ABC- Irritability From Baseline | week 5 | -0.13 units on a scale |
| Sleep Parent Training | Change in ABC- Irritability From Baseline | week 10 | -2.32 units on a scale |
| Sleep Parent Education | Change in ABC- Irritability From Baseline | week 10 | -2.6 units on a scale |
| Sleep Parent Education | Change in ABC- Irritability From Baseline | week 5 | -2.00 units on a scale |
p-value: 0.81Mixed Models Analysis
Secondary
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
Time frame: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Sleep Parent Training | Change in PSI From Baseline | Week 5 | -6.23 units on a scale |
| Sleep Parent Training | Change in PSI From Baseline | Week 10 | -9.88 units on a scale |
| Sleep Parent Education | Change in PSI From Baseline | Week 5 | -4.94 units on a scale |
| Sleep Parent Education | Change in PSI From Baseline | Week 10 | -8.77 units on a scale |
p-value: 0.77Mixed Models Analysis
Secondary
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.
Time frame: Baseline, 5 week, 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Sleep Parent Training | PSOC Change From Baseline | Week 5 | 2.9 units on a scale |
| Sleep Parent Training | PSOC Change From Baseline | Week 10 | 3.96 units on a scale |
| Sleep Parent Education | PSOC Change From Baseline | Week 5 | -1.81 units on a scale |
| Sleep Parent Education | PSOC Change From Baseline | Week 10 | -0.68 units on a scale |
p-value: 0.003Mixed Models Analysis
Other Pre-specified
Treatment Fidelity
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.
Time frame: 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
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Sleep Parent Training | Treatment Fidelity | Treatment Integrity | 98.05 percentage |
| Sleep Parent Training | Treatment Fidelity | Parent Adherence | 97.69 percentage |
| Sleep Parent Education | Treatment Fidelity | Treatment Integrity | 98.27 percentage |
| Sleep Parent Education | Treatment Fidelity | Parent Adherence | 99.15 percentage |