Flashed Light Therapy for Adolescents With ADHD and Delayed Sleep Timing

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Flashed Light Therapy for Adolescents With ADHD and Delayed Sleep Timing

Conditions
-----------------
ADHD

Intervention / Treatment
-----------------
* Device: Flashed Light Therapy
* Behavioral: Videoconference-delivered Cognitive Behavioral Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age of 14 to 17 years Current DSM-5 diagnosis of attention-deficit/hyperactivity disorder (any type) Self-reported average bedtime of 11:00 pm or later, with difficulty shifting bedtime earlier and difficulty waking up early enough in the morning Evening chronotype (i.e., score ≤ 27 on the Morningness-Eveningness scale for Children) Clinically significant ADHD severity (ADHD-Rating Scale-5 score ≥ 24) Moderate global functioning impairment or worse (Clinical Global Impression-Severity scale score ≥ 4) Attending school (i.e., standard school year or summer school) during study enrollment Fluency in English Exclusion Criteria: Current or lifetime diagnosis of bipolar Disorder, psychosis, autism spectrum disorder, or pervasive developmental disorder Alcohol or substance dependence or suicidality within the past 6 months Current depression or anxiety in the severe range or higher Sleep disorder present besides delayed sleep-wake phase disorder (Clinical Sleep History Interview) Sleep solely in the prone position (i.e., on stomach) Full scale IQ ≤ 80 (Wechsler Abbreviated Scale for Intelligence-II) Use of any over-the-counter (e.g., melatonin, Benadryl) or prescribed sleep medication in the past month or planned use during the study Changes to any psychiatric medication within one month of study enrollment or planned changes during the study Use of photosensitizing medication within one month of study enrollment or planned during the study Participation in behavior therapy for sleep and/or ADHD within 3 months of study enrollment or planned participation during the course of the study Use of light therapy within 6 months of study enrollment or planned use during the study Travel across > 2 time zones within one month of study enrollment or planned travel outside of the time zone of participation during the study Structural barriers to sleep (e.g., night shift work, extracurriculars scheduled until late in the evening, early rising for sports practice) Medical or neurological condition (e.g., seizure disorder, chronic migraines) that would interfere in the individual's ability to participate

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 17 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1) Flashed Light Therapy, 2) Flashed Light Therapy with Cognitive Behavioral Therapy<br>Treatment Phase 1 (2 weeks duration): light flashes administered for 60 minutes daily beginning 75 minutes prior to the participant's average morning wake time and ending 15 minutes before average morning wake time. Treatment Phase 2 (4 weeks duration): will begin immediately following phase 1 and involve daily light flashes (as described above) combined with weekly 50-minute videoconference-delivered cognitive-behavioral therapy. | Device: Flashed Light Therapy<br>* Light flashes will be presented over 60 minutes as 3-millilisecond flashes of white light at 4,000 lux every 20 seconds<br>* Other names: Light flashes;Behavioral: Videoconference-delivered Cognitive Behavioral Therapy<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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). | 7 weeks | 
| Treatment Tolerability: Treatment Adherence | The number of days the participant was exposed to morning light therapy per self-report tracker. | 7 weeks | 
| Treatment Tolerability: Attrition | The number of participants who withdrew from the study out of the total cases enrolled. | 7 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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). | 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. | 7 weeks | 
| 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. | 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. | 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). | 7 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ADHD, light flashes, CBT, sleep