*Research Question*

Does a weighted blanket impact sleep quality among children with autism, sleep disturbances, and sensory over-responsivity?

### **2. Materials and Methods**

The current study implemented an ABA research design with pre- and post-test phases [26]. The research design was selected based upon the alignment of the purpose and research question guiding the study. Further, the design is used due to the low availability of a clinical sample in a largely rural and medically underserved area in the Intermountain West region of the United States. The overall study aimed at increasing the duration of the intervention phase, using a caregiver questionnaire tracking participant behavioral changes and using a sample of younger children that were implemented in the Gringras et al. [14] and Gee et al. [15,16] studies.

The pre-test phase consisted of participants' caregivers completing subjective measures related to their child's sleep behavior patterns and sensory processing preferences/challenges. The Sensory Processing Measure–Preschool version (SPM-P) [27] and Children's Sleep Habits Questionnaire (CSHQ) [28] were administered to ensure the participant met the study's inclusion criteria. The SPM-P is a judgment-based rating scale to measure distinct sensory processing patterns (tactile, vestibular, auditory, visual, etc.), praxis, and social participation among preschool-aged children (3–5 years of age). The CSHQ is a judgment-based rating scale completed by caregivers to measure sleep habits in children ages 4 to 10. The measure has an internal consistency of 0.78 with a sensitivity of 0.80. The classification accuracy of sleep disorders among the targeted age range is 80% [27].

The first phase of the study labeled the baseline phase, lasted for at least seven days. During the baseline phase, the participants' caregivers completed a five-question, non-standardized Daily Caregiver Survey that quantitatively identified the time to fall asleep at night, duration of night sleep, number of times the child woke up during the night, and a child's morning mood. The survey was developed as an attempt to integrate recommendations from the Gringras et al. study [14]. After completing the baseline measures, the participants transitioned to a 14-day weighted blanket intervention phase. Throughout the intervention phase, participants slept with a weighted blanket, and the caregivers continued to complete the daily surveys. After completing the intervention phase, the weighted blankets were withdrawn, and the study transitioned into the withdrawal phase. During the withdrawal phase, caregivers continued to complete daily surveys for eight days.

### *2.1. Method of Recruitment*

The Human Subjects Committee approved the study at Idaho State University (Pocatello, ID) (on 10 February 2017, IRB-FY2016-170). Study participants were recruited via brochures distributed by the first author and primary investigator (PI) to local pediatricians, pediatric occupational therapists, and speech-language pathologists. Interested caregivers contacted the PI directly to receive additional study details and ask questions. During the initial phone conversation, the PI asked several questions to determine eligibility (see inclusion criteria). If the participant met the inclusion criteria and demonstrated a willingness to participate in the study, written informed consent was obtained. Informed consent was obtained before the participants beginning the study.

### *2.2. Inclusion Criteria*

Study participants were required to meet the following inclusion criteria to participate in this study. The child needed to:


The caregiver needed to:


Participants and caregivers were excluded from the study if they did not meet the above-listed inclusion criteria.

### Description of the Participants

Participant one, using the pseudonym John, was a four-year, five-month-old male child with a reported autism diagnosis that included a cognitive impairment. The findings from the SPM-P [27] caregiver report screener indicated a Definite Dysfunction in the behavioral manifestations of over-responsivity to tactile (*T*-Score of 72), auditory (*T*-Score of 78), and visual sensory (*T*-Score of 70) stimuli. The qualitative results from the CSHQ [28] caregiver report ratings indicated he demonstrated poor sleep quality as evidenced by difficulty falling asleep ("always"—seven days a week), staying asleep ("always"—seven days a week), wakes up too early ("usually"—five days a week) and experiences a poor morning mood ("usually"—five days a week). No other medical comorbidities were reported.

Participant two using the pseudonym Katie, was a four year, one-month-old female child with a reported diagnosis of autism. The findings from the SPM-P [28] caregiver report screener indicated a Definite Dysfunction in the behavioral manifestations of over-responsivity to tactile (*T*-Score of 80), auditory (*T*-Score of 74), and visual sensory (*T*-Score of 73) stimuli. The qualitative results from the CSHQ caregiver report ratings indicated that she demonstrated difficulty staying asleep (wakes more than once at night ("usually"—five days a week)), wakes up too early ("always"—seven days a week) and experiences a poor morning mood ("usually"—five days a week). No other medical comorbidities were reported.

### *2.3. Dependent Variables*

Daily Caregiver Surveys (delivered online via SurveyMonkey®) were completed throughout all study phases. The non-standardized survey consisted of six subjective questions assessing the participants' sleep habits from the previous day and mood the morning the survey was completed. Each survey was completed by the caregiver based upon their best recollection of the previous night's events. The survey tracked the caregivers' perception of their child's sleep latency, number of naps, duration of naps, number of night wakings, sleep duration, and morning mood. Morning mood was operationalized as feelings, varying in intensity and duration, and usually involving more than one emotion [29]. In this case, the authors identified agitation/calm as one emotion related to mood. The assessment of morning mood (i.e., agitation/calm) allowed for the participants' caregivers to rate the

current level of the child's agitation compared to the prior day using a five-point Likert like scale (more agitated, slightly more agitated, no di fference, slightly calmer, and more calm).

The Sense [30] Sleep App was used to objectively track variables, including the participant's overall sleep quality, total hours of sleep, and the number of hours of deep sleep. The Sense Sleep App included a motion tracker called a "pill" attached to the participants' pillowcase or sheet at the head of the bed. The tracker's base component sat next to the bed and captured movement-related information from the pill attached to the participant's pillow or sheet. The Sense Sleep App exported data that were transmitted and stored from the pill and the base each morning to an Apple Inc. device (e.g., iPad provided by the PI to each participant). Upon return of the iPad at the end of the research study, the data were transferred to a Microsoft Excel spreadsheet. This commercially purchased device had not been utilized in any peer-reviewed literature. Due to the proprietary nature of the device, information related to reliability and validity were unavailable. From a pragmatic perspective, the Sense Sleep App was used because it was a non-wearable system. The target population is young children (3–6 years old) who also demonstrated tactile sensory over-responsivity, which removed the option of using wearable devices such as the Garmin Jr. HR. Additionally, the cost was approximately USD 99.00, which is a ffordable for most clinicians to utilize in practice.
