Engaging Stakeholders to Optimize an Evidence Based Transdiagnostic Sleep & Circadian Intervention for Autistic Adults

/ABSTRACT This K23 proposal will address the critical need for evidence-based transdiagnostic sleep interventions for autistic adults. Autistic adults frequently report a multitude of pervasive sleep and circadian problems, including difficulties initiating and maintaining sleep, excessive sleepiness, delayed phase, and irregular sleep– wake schedules. These sleep and circadian problems often occur in unison rather as isolated problems, and contribute to the onset, worsening, and continuation of mental health disorders. This project will adapt and pilot the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C), an effective sleep intervention, so that its content and delivery are effective and sustainable for autistic adults. Aim 1 is to iteratively adapt as needed and pilot TranS-C for autistic adults (18-65 yrs). Preliminary data, iterative pilot testing with autistic adults (N=15-24), and input from an advisory panel of autistic adults (N=4), caregivers (N=4), medical providers (N=2), and behavioral health clinicians (N=2) will guide needed adaptations. Assessments for Aim 1 include multidimensional sleep health (MSH) (actigraphy, self-report measures), as well as implementation science outcomes (feasibility, acceptability, engagement, and fidelity). Aim 2 is to conduct a pilot randomized trial of the adapted TranS-C to examine intervention efficacy, as well as feasibility, acceptability, engagement and fidelity. Autistic adults (18-65 yrs) (N=90) will be randomly assigned to the adapted TranS-C, traditional TranS-C, or a wait-list control, with assessments of multidimensional sleep health (MSH) (actigraphy, self-report measures), as well as self-report measures of social, emotional, and cognitive functioning, at pretreatment, posttreatment, and 3-month follow-up. Aim 3 is to evaluate hypothesized mediational processes that may explain relationship between sleep and circadian problems and social, emotional, and cognitive functioning in autistic adults. The proposed research and the career development plan will support Dr. Lenker’s training goals to acquire skills and knowledge in: (1) qualitative and mixed methods for intervention adaptation and development; (2) conduct of clinical trials, especially for TranS-C and Autism; and (3) the application of implementation science methods and frameworks to clinical sleep research. The resources and expertise of the assembled team of interdisciplinary mentors will provide an outstanding context to propel Dr. Lenker’s career. This project will also provide necessary data for Dr. Lenker’s future R01 submission of a large-scale effectiveness-implementation trial of a transdiagnostic sleep intervention trial. This project aligns with NICHD’s priorities, as it focuses on the complexity of co-occurring conditions such as sleep and circadian problems for autistic adults within a multidimensional and transdiagnostic context, as well as the development of effective patient-centered treatment options for autistic adults utilizing implementation science frameworks. Project Number: 1K23HD118526-01A1 | Fiscal Year: 2026 | NIH Institute/Center: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Principal Investigator: Kristina Lenker | Institution: PENNSYLVANIA STATE UNIV HERSHEY MED CTR, HERSHEY, PA | Award Amount: $170,851 | Activity Code: K23 | Study Section: Special Emphasis Panel[ZRG1 BP-R (90)] View on NIH RePORTER: https://reporter.nih.gov/project-details/11299274