Treating Sleep in Teens With ADHD

NCT04270812 | Completed

• 1 other identifier: 2018-0649
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

ADHD; Sleep

Outcome Measures

Primary Outcomes (1)

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

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

  Immediately after the intervention

Secondary Outcomes (5)

• Change in sleep duration

  Immediately after the intervention

• Change in sleep onset

  Immediately after the intervention

• Change in sleep disturbance

  Immediately after the intervention

• Change in objective sleep functioning

  Immediately after the intervention

• Change in circadian preference

  Immediately after the intervention

Study Arms (1)

Sleep Treatment

EXPERIMENTAL

This arm consists of the sleep treatment that will be administered to all participants in the single-arm open trial.

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

Interventions

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.

Sleep Treatment

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Related Publications (1)

• Becker SP, Duraccio KM, Sidol CA, Fershtman CEM, Byars KC, Harvey AG. Impact of a Behavioral Sleep Intervention in Adolescents With ADHD: Feasibility, Acceptability, and Preliminary Effectiveness From a Pilot Open Trial. J Atten Disord. 2022 May;26(7):1051-1066. doi: 10.1177/10870547211056965. Epub 2021 Nov 5.

  PMID: 34738484 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a single group open trial.

Study Record Dates

• First Submitted: February 11, 2020
• First Posted: February 17, 2020
• Study Start: October 16, 2018
• Primary Completion: May 31, 2020
• Study Completion: October 31, 2020
• Last Updated: July 28, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)