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Treating Sleep in Teens With ADHD

Treating Sleep Problems in Adolescents With ADHD: A Pilot Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04270812
Enrollment
14
Registered
2020-02-17
Start date
2018-10-16
Completion date
2020-10-31
Last updated
2021-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ADHD, Sleep

Brief summary

Sleep problems are common in adolescence and recognized as an international public health concern given their links to a range of adverse outcomes. Adolescents with attention-deficit/hyperactivity disorder (ADHD) experience more sleep problems than their peers, including delayed sleep onset, shorter sleep duration, poorer sleep quality, more sleep variability, and greater daytime sleepiness. Further, research conducted by the investigator's team has shown that sleep problems are strongly associated with - and causal contributors to - functional impairment in adolescents with ADHD, including increased mood, behavior, and academic problems. However, sleep problems are not currently addressed in any evidence-based treatment for adolescents with ADHD, and no study has evaluated an intervention targeting sleep problems in adolescents with ADHD. This is a notable gap in the field since consensus statements on sleep suggest that treating sleep problems may improve ADHD and associated impairments. Evidence-based cognitive-behavioral sleep interventions, including the Transdiagnostic Sleep and Circadian Intervention for Youth (TranS-C) intervention, are effective for improving sleep and associated impairments (e.g., attention, mood) in adolescents with sleep problems. However, these interventions have never been tested in adolescents with ADHD specifically. This will be the first to evaluate a cognitive-behavioral sleep intervention (TranS-C) in adolescents with ADHD who experience co-occurring sleep problems. This study will recruit 15 adolescents with ADHD and sleep problems to enroll in and complete an open trial of the TranS-C intervention to evaluate its feasibility, acceptability, and preliminary efficacy. Findings will provide key pilot data regarding treatment of sleep problems in adolescents with ADHD.

Interventions

BEHAVIORALTransdiagnostic Sleep and Circadian Intervention for Youth (TranS-C)

TranS-C adopts a modular approach to reversing the psychosocial, behavioral, and cognitive processes maintaining sleep problems via 4 cross-cutting modules (introduced in the first session and included in every session thereafter), 4 core modules and 7 optional modules. TranS-C typically involves 6-8 individual, weekly 50-minute sessions.

Sponsors

Children's Hospital Medical Center, Cincinnati
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

This is a single group open trial.

Eligibility

Sex/Gender
ALL
Age
13 Years to 17 Years
Healthy volunteers
No

Inclusion criteria

1. Between 13 and 17 years of age at the first TranS-C session. 2. Estimated IQ ≥ 80 as assessed by the Kaufman Brief Intelligence Test, Second Edition (KBIT-2). 3. Meet full DSM-5 criteria for ADHD (per protocol). 4. Meet criteria for sleep problems (per protocol). 5. Sufficient English language ability necessary to complete study measures and intervention per parent and/or research staff judgment. 6. If applicable: If the adolescent is taking a medication for ADHD or another psychiatric disorder (e.g., anxiety, depression), the adolescent must be on a stable medication dose/schedule for at least one month, and families will also be asked to not change/add medications the adolescent takes during the intervention period.

Exclusion criteria

1. Children who have participated in a behavioral or cognitive-behavioral sleep treatment in the past year will be ineligible. 2. Children with a parent-report diagnosis of autism spectrum disorder, bipolar disorder, obsessive-compulsive disorder, or psychosis will be excluded. 3. Children taking a prescribed medication for sleep problems per parent report (not including melatonin). 4. Significant visual, hearing, or speech impairment not helped with corrective or assistive devices (e.g., glasses, hearing aids) per parent report or study staff judgment.

Design outcomes

Primary

MeasureTime frameDescription
Change in overall sleep quality: Pittsburgh Sleep Quality Index (PSQI)Immediately after the interventionOverall sleep quality measured used the adolescent-completed Pittsburgh Sleep Quality Index (PSQI)

Secondary

MeasureTime frameDescription
Change in sleep durationImmediately after the interventionSleep duration assessed using daily sleep diary
Change in sleep onsetImmediately after the interventionSleep onset time assessed using daily sleep diary
Change in sleep disturbanceImmediately after the interventionOverall sleep disturbance measured used the parent-completed Children's Sleep Habits Questionnaire (CSHQ)
Change in objective sleep functioningImmediately after the interventionObjective sleep functioning assessed using actigraphy
Change in circadian preferenceImmediately after the interventionCircadian preference assessed with the adolescent-completed Children's Morningness-Eveningness Preference (CMEP) Scale

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026