Cincinnati, Ohio 45229

  • Sleep

Purpose:

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.


Criteria:

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 is Available At:


Original ID:

2018-0649


NCT ID:

NCT04270812


Secondary ID:


Study Acronym:


Brief Title:

Treating Sleep in Teens With ADHD


Official Title:

Treating Sleep Problems in Adolescents With ADHD: A Pilot Study


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

N/A


Minimum Age:

13 Years


Maximum Age:

17 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Children's Hospital Medical Center, Cincinnati


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

15


Enrollment Type:

Anticipated


Study Dates

Start Date:October 16, 2018
Completion Date:October 31, 2020
Completion Type:Anticipated
Primary Completion Date:May 31, 2020
Primary Completion Type:Anticipated
Verification Date:February 2020
Last Changed Date:February 12, 2020
First Received Date:February 11, 2020

Study Outcomes

Outcome Type:Primary Outcome
Measure:Change in overall sleep quality: Pittsburgh Sleep Quality Index (PSQI)
Time Frame:Immediately after the intervention
Safety Issues:False
Description:Overall sleep quality measured used the adolescent-completed Pittsburgh Sleep Quality Index (PSQI)
Outcome Type:Secondary Outcome
Measure:Change in sleep duration
Time Frame:Immediately after the intervention
Safety Issues:False
Description:Sleep duration assessed using daily sleep diary
Outcome Type:Secondary Outcome
Measure:Change in sleep onset
Time Frame:Immediately after the intervention
Safety Issues:False
Description:Sleep onset time assessed using daily sleep diary
Outcome Type:Secondary Outcome
Measure:Change in sleep disturbance
Time Frame:Immediately after the intervention
Safety Issues:False
Description:Overall sleep disturbance measured used the parent-completed Children's Sleep Habits Questionnaire (CSHQ)
Outcome Type:Secondary Outcome
Measure:Change in objective sleep functioning
Time Frame:Immediately after the intervention
Safety Issues:False
Description:Objective sleep functioning assessed using actigraphy
Outcome Type:Secondary Outcome
Measure:Change in circadian preference
Time Frame:Immediately after the intervention
Safety Issues:False
Description:Circadian preference assessed with the adolescent-completed Children's Morningness-Eveningness Preference (CMEP) Scale

Study Interventions

Intervention Type:Behavioral
Name:Transdiagnostic Sleep and Circadian Intervention f
Description: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.
Arm Name:Sleep Treatment

Study Arms

Study Arm Type:Experimental
Arm Name:Sleep Treatment
Description:This arm consists of the sleep treatment that will be administered to all participants in the single-arm open trial.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Children's Hospital Medical Center, Cincinnati

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: September 16, 2021

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