Treating Sleep in Teens With ADHD

Treating Sleep Problems in Adolescents With ADHD: A Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Sleep; ADHD
• Intervention / Treatment: Behavioral: Transdiagnostic Sleep and Circadian Intervention for Youth (TranS-C)

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 15 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Sleep Treatment; 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); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in sleep duration	Sleep duration assessed using daily sleep diary	Immediately after the intervention
Change in sleep onset	Sleep onset time assessed using daily sleep diary	Immediately after the intervention
Change in sleep disturbance	Overall sleep disturbance measured used the parent-completed Children's Sleep Habits Questionnaire (CSHQ)	Immediately after the intervention
Change in objective sleep functioning	Objective sleep functioning assessed using actigraphy	Immediately after the intervention
Change in circadian preference	Circadian preference assessed with the adolescent-completed Children's Morningness-Eveningness Preference (CMEP) Scale	Immediately after the intervention

Collaborators and Investigators

• Sponsor: Children's Hospital Medical Center, Cincinnati

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2018
• Primary Completion (Actual): May 31, 2020
• Study Completion (Actual): October 31, 2020

Study Registration Dates

• First Submitted: February 11, 2020
• First Submitted That Met QC Criteria: February 12, 2020
• First Posted (Actual): February 17, 2020

Study Record Updates

• Last Update Posted (Actual): July 28, 2021
• Last Update Submitted That Met QC Criteria: July 27, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 2018-0649

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No