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NCT Number: NCT04270812

Treating Sleep in Teens With ADHD

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.

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Key information

Conditions

ADHD Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders Sleep

Age range

13 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Between 13 and 17 years of age at the first TranS-C session.
  • Estimated IQ ≥ 80 as assessed by the Kaufman Brief Intelligence Test, Second Edition (KBIT-2).
  • Meet full DSM-5 criteria for ADHD (per protocol).
  • Meet criteria for sleep problems (per protocol).
  • Sufficient English language ability necessary to complete study measures and intervention per parent and/or research staff judgment.
  • 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

  • Children who have participated in a behavioral or cognitive-behavioral sleep treatment in the past year will be ineligible.
  • Children with a parent-report diagnosis of autism spectrum disorder, bipolar disorder, obsessive-compulsive disorder, or psychosis will be excluded.
  • Children taking a prescribed medication for sleep problems per parent report (not including melatonin).
  • 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.

Treatment and study plan

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

Behavioral

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.

Primary outcomes

  1. Change in overall sleep quality: Pittsburgh Sleep Quality Index (PSQI)

    Time frame: Immediately after the intervention

    Overall sleep quality measured used the adolescent-completed Pittsburgh Sleep Quality Index (PSQI)

Secondary outcomes

  1. Change in sleep duration

    Time frame: Immediately after the intervention

    Sleep duration assessed using daily sleep diary

  2. Change in sleep onset

    Time frame: Immediately after the intervention

    Sleep onset time assessed using daily sleep diary

  3. Change in sleep disturbance

    Time frame: Immediately after the intervention

    Overall sleep disturbance measured used the parent-completed Children's Sleep Habits Questionnaire (CSHQ)

  4. Change in objective sleep functioning

    Time frame: Immediately after the intervention

    Objective sleep functioning assessed using actigraphy

  5. Change in circadian preference

    Time frame: Immediately after the intervention

    Circadian preference assessed with the adolescent-completed Children's Morningness-Eveningness Preference (CMEP) Scale

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Registry information

Official study title

Treating Sleep Problems in Adolescents With ADHD: A Pilot Study

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Feb 17, 2020
Registry last updated
Jul 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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