The primary aim of the present research project is to examine the feasibility, as measured by treatment perceptions, and tolerability, as measured by adherence and attrition, of two weeks of flashed light therapy alone followed by four weeks of daily flashed light therapy combined with four weekly videoconference-delivered cognitive behavioral therapy sessions targeting circadian rhythms and sleep in four adolescents aged 14 to 17 years with attention-deficit/hyperactivity disorder and delayed sleep-wake schedules.
Participation in this research will last about 7 weeks. Participation will involve an initial screening visit lasting 3 hours to assess eligibility. This visit will involve interviews and tasks to assess for psychiatric diagnosis, sleep history, ADHD severity, and thought patterns. Participants and parents will also complete questionnaires assessing parent-reported and self-reported ADHD severity, personal and family demographics, and medical and psychiatric history. Following this visit, participants will be asked to monitor their sleep for 7 nights using a sleep watch and sleep diary, and provide daily report of bedtimes and risetimes via text message. After sleep monitoring, an 8-hour baseline assessment visit involving interviews, questionnaires, and saliva sampling will be scheduled from 7 hours before average habitual bedtime up until average bedtime to assess the internal body clock. The morning following the baseline assessment, light therapy will begin and continue daily for two weeks. During the two-week period, participants will monitor sleep nightly using a sleep watch and sleep diary. Following termination of the two-week course of flashed light therapy, participants will complete an 8-hour mid-treatment assessment involving interviews, questionnaires, and saliva sampling, as described above. Following this assessment, participants will begin weekly 50-minute individual videoconference-delivered cognitive behavioral therapy while continuing to use the flashed light therapy device and monitor sleep (via sleep diary, watch, and sleep location verification) for a duration of four weeks. Following treatment, participants will have a post-treatment 8-hour assessment, again involving interviews, questionnaires, and a salivary assessment of the internal body clock, as described above.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
Light flashes will be presented over 60 minutes as 3-millilisecond flashes of white light at 4,000 lux every 20 seconds
Treatment will involve psychoeducation on sleep, circadian rhythms and light exposure, motivational interviewing, advancing of bedtime schedule, time management and coping with poor sleep, sleep hygiene, stimulus control, sleep restriction, and cognitive restructuring for worry.
Semel Institute for Neuroscience and Human Behavior, University of California, Los Angeles
Los Angeles, California, United States
Treatment Feasibility: Child-reported
Child rating of how acceptable they find the treatment to be on a scale from 1 (very unacceptable) to 7 (very acceptable).
Time frame: 7 weeks
Treatment Feasibility: Parent-reported
Parent rating of how acceptable they find the treatment to be on a scale from 1 (very unacceptable) to 7 (very acceptable).
Time frame: 7 weeks
Treatment Tolerability: Treatment Adherence
The number of days the participant was exposed to morning light therapy per self-report tracker.
Time frame: 7 weeks
Treatment Tolerability: Attrition
The number of participants who withdrew from the study out of the total cases enrolled.
Time frame: 7 weeks
Assessment Tolerability: Child-reported
Child rating of how tolerable they find the study assessments to be on a scale from 1 (very intolerable) to 7 (very tolerable).
Time frame: 7 weeks
Assessment Tolerability: Parent-reported
Parent rating of how tolerable they find the study assessments to be on a scale from 1 (very intolerable) to 7 (very tolerable).
Time frame: 7 weeks
Treatment Sensitivity of Circadian Phase
Change in clock time of dim-light melatonin onset across baseline, mid-treatment, and post-treatment assessment timepoints.
Time frame: 7 weeks
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TREATMENT
Masking
NONE
Enrollment
6
Treatment Sensitivity of Sleep Onset Time
Change in clock time of sleep onset across baseline, mid-treatment, and post-treatment assessment timepoints, as measured by actigraphy.
Time frame: 7 weeks
Treatment Sensitivity of Sleep Duration
Change in total sleep time (total number of minutes spent asleep during the sleep episode) across baseline, mid-treatment, and post-treatment, as measured by actigraphy.
Time frame: 7 weeks
Treatment Sensitivity of Clinician-rated ADHD Severity (ADHD-RS-5)
Change in clinician rated ADHD Rating Scale-5 (ADHD-RS-5) total score across baseline, mid-treatment, and post-treatment assessment timepoints. The ADHD-RS-5 is an 18-item clinical rated scale assessing ADHD symptoms and the extent to which these symptoms exact impairment (DuPaul et al., 2016). Clinicans rate symptom severity and impairment on a scale ranging from 0 (none) to 3 (severe).
Time frame: 7 weeks