Telehealth Delivery of Treatment for Sleep Disturbances in Young Children With Autism Spectrum Disorder
- Conditions
- Sleep DisturbanceAutism Spectrum Disorder
- Interventions
- Behavioral: Sleep Parent TrainingBehavioral: Sleep Parent Education
- Registration Number
- NCT03668873
- Lead Sponsor
- The Cleveland Clinic
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 90
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sleep Parent Training Sleep Parent Training 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. Sleep Parent Education 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
Cleveland Clinic Centerl for Autism
🇺🇸Cleveland, Ohio, United States