ACTIVE_NOT_RECRUITING

Flashed Light Therapy for Adolescents With ADHD and Delayed Sleep Timing

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Flashed Light Therapy for Adolescents With ADHD and Delayed Sleep Timing

Quick Facts

Study Start:2023-10-20

Study Completion:2027-03-20

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06036420

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:14 Years to 17 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion Criteria
1. Age of 14 to 17 years 2. Current DSM-5 diagnosis of attention-deficit/hyperactivity disorder (any type) 3. Self-reported average bedtime of 11:00 pm or later, with difficulty shifting bedtime earlier and difficulty waking up early enough in the morning 4. Evening chronotype (i.e., score ≤ 27 on the Morningness-Eveningness scale for Children) 5. Clinically significant ADHD severity (ADHD-Rating Scale-5 score ≥ 24) 6. Moderate global functioning impairment or worse (Clinical Global Impression-Severity scale score ≥ 4) 7. Attending school (i.e., standard school year or summer school) during study enrollment 8. Fluency in English	1. Current or lifetime diagnosis of bipolar Disorder, psychosis, autism spectrum disorder, or pervasive developmental disorder 2. Alcohol or substance dependence or suicidality within the past 6 months 3. Current depression or anxiety in the severe range or higher 4. Sleep disorder present besides delayed sleep-wake phase disorder (Clinical Sleep History Interview) 5. Sleep solely in the prone position (i.e., on stomach) 6. Full scale IQ ≤ 80 (Wechsler Abbreviated Scale for Intelligence-II) 7. Use of any over-the-counter (e.g., melatonin, Benadryl) or prescribed sleep medication in the past month or planned use during the study 8. Changes to any psychiatric medication within one month of study enrollment or planned changes during the study 9. Use of photosensitizing medication within one month of study enrollment or planned during the study 10. Participation in behavior therapy for sleep and/or ADHD within 3 months of study enrollment or planned participation during the course of the study 11. Use of light therapy within 6 months of study enrollment or planned use during the study 12. Travel across \> 2 time zones within one month of study enrollment or planned travel outside of the time zone of participation during the study 13. Structural barriers to sleep (e.g., night shift work, extracurriculars scheduled until late in the evening, early rising for sports practice) 14. Medical or neurological condition (e.g., seizure disorder, chronic migraines) that would interfere in the individual's ability to participate

Inclusion Criteria

Exclusion Criteria

1. Age of 14 to 17 years
2. Current DSM-5 diagnosis of attention-deficit/hyperactivity disorder (any type)
3. Self-reported average bedtime of 11:00 pm or later, with difficulty shifting bedtime earlier and difficulty waking up early enough in the morning
4. Evening chronotype (i.e., score ≤ 27 on the Morningness-Eveningness scale for Children)
5. Clinically significant ADHD severity (ADHD-Rating Scale-5 score ≥ 24)
6. Moderate global functioning impairment or worse (Clinical Global Impression-Severity scale score ≥ 4)
7. Attending school (i.e., standard school year or summer school) during study enrollment
8. Fluency in English

1. Current or lifetime diagnosis of bipolar Disorder, psychosis, autism spectrum disorder, or pervasive developmental disorder
2. Alcohol or substance dependence or suicidality within the past 6 months
3. Current depression or anxiety in the severe range or higher
4. Sleep disorder present besides delayed sleep-wake phase disorder (Clinical Sleep History Interview)
5. Sleep solely in the prone position (i.e., on stomach)
6. Full scale IQ ≤ 80 (Wechsler Abbreviated Scale for Intelligence-II)
7. Use of any over-the-counter (e.g., melatonin, Benadryl) or prescribed sleep medication in the past month or planned use during the study
8. Changes to any psychiatric medication within one month of study enrollment or planned changes during the study
9. Use of photosensitizing medication within one month of study enrollment or planned during the study
10. Participation in behavior therapy for sleep and/or ADHD within 3 months of study enrollment or planned participation during the course of the study
11. Use of light therapy within 6 months of study enrollment or planned use during the study
12. Travel across \> 2 time zones within one month of study enrollment or planned travel outside of the time zone of participation during the study
13. Structural barriers to sleep (e.g., night shift work, extracurriculars scheduled until late in the evening, early rising for sports practice)
14. Medical or neurological condition (e.g., seizure disorder, chronic migraines) that would interfere in the individual's ability to participate

Contacts and Locations

Principal Investigator

Emily J Ricketts, Ph.D.

PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Study Locations (Sites)

Semel Institute for Neuroscience and Human Behavior, University of California, Los Angeles

Los Angeles, California, 90095

United States

Collaborators and Investigators

Sponsor: University of California, Los Angeles

Emily J Ricketts, Ph.D., PRINCIPAL_INVESTIGATOR, University of California, Los Angeles

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-20

Study Completion Date2027-03-20

Study Record Updates

Study Start Date2023-10-20

Study Completion Date2027-03-20

Terms related to this study

Keywords Provided by Researchers

ADHD
light flashes
CBT
sleep

Additional Relevant MeSH Terms

ADHD