Targeted Intervention for Insufficient Sleep Among Typically-Developing Adolescents

NCT04163003 | Completed

• 2 other identifiers: STUDY19080033K23HD087433
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

The overall aim of Dr. Levenson's research proposal is to test the acceptability, feasibility, and preliminary outcomes of a sleep promotion program delivered to 13-15 year olds who report insufficient sleep. Dr. Levenson will examine the feasibility and acceptability of the program through a randomized pilot trial (n=40) that uses a two-period, wait-list control design. Then, Dr. Levenson will test whether the program is associated with changes in sleep, motivation, and four outcome domains: academic functioning, attention, risk behavior, and affect. Such a broadly relevant program has the potential for enormous public health impact by improving sleep and facilitating healthy development across a range of domains among typically-developing adolescents who are highly vulnerable to adverse consequences.

Conditions

Sleep Disturbance

Outcome Measures

Primary Outcomes (7)

• Attrition

  Participant attrition rate

  4 weeks

• Response Rate

  Participant response rate to electronic intervention prompts

  4 weeks

• Adherence

  A locally-developed Sleep Promotion Program Rating form indicates which program components covered in each clinician session. The measure is a checklist that indicates the presence or absence of each component covered in the session.

  1 session

• Participant Satisfaction

  A locally-developed Treatment Satisfaction Questionnaire measures program satisfaction. Scores range from 18 to 75, with higher scores indicating greater satisfaction.

  4 weeks

• Sleep Diary Sleep Duration

  Average sleep duration (in hours and minutes) as measured by sleep diary

  4 weeks

• Sleep Diary Sleep Timing

  Average sleep timing as measured by sleep diary

  4 weeks

• Sleep Diary Weekend-Weekday Sleep Timing Differences

  Difference in average weekend and weekday sleep timing as measured by sleep diary

  4 weeks

Secondary Outcomes (3)

• Actigraphy Sleep Duration

  4 weeks

• Actigraphy Sleep Timing

  4 weeks

• Actigraphy Weekend-Weekday Sleep Timing Differences

  4 weeks

Other Outcomes (4)

• Academic Functioning

  4 weeks

• Attention

  4 weeks

• Affect

  4 weeks

Study Arms (2)

TAPAS

EXPERIMENTAL

Participants will participate in the TAPAS intervention, which will consist of one in-person engagement session with a therapist and 8 weeks of web-based automated intervention prompts. The program will utilize empirically supported approaches for promoting sleep health, delivered in-person and via text-message, focusing on: tailored psychoeducation, motivation and efficacy to change sleep, extending sleep duration, and regularizing sleep timing across the week.

Behavioral: Targeted Approaches for Promoting Adolescent Sleep (TAPAS)

Sleep monitoring only, then TAPAS

EXPERIMENTAL

Participants will participate in sleep monitoring only first, then participate in the TAPAS intervention. First, participants will monitor sleep with sleep diary, but they will not receive feedback or any other information on to sleep.TAPAS will consist of one engagement session with a therapist and 4 weeks of web-based automated intervention prompts. The program will utilize empirically supported approaches for promoting sleep health, delivered in-person and via text-message, focusing on: tailored psychoeducation, motivation and efficacy to change sleep, extending sleep duration, and regularizing sleep timing across the week. Sleep monitoring is proposed to last the same duration as the targeted intervention in this arm.

Behavioral: Targeted Approaches for Promoting Adolescent Sleep (TAPAS); Behavioral: Sleep Monitoring Only

Interventions

Targeted Approaches for Promoting Adolescent Sleep (TAPAS) BEHAVIORAL

The targeted intervention is a three part sleep program, involving a 2- minute psychoeducation video, an in-person session with a clinician focusing on sleep, and web-based goal setting related to sleep behaviors. Intervention approaches to promoting adolescent sleep and reducing insufficient sleep use a motivational interviewing style, rooted in cognitive-behavioral strategies for improving sleep.

Also known as: TAPAS

Sleep monitoring only, then TAPAS; TAPAS

Sleep Monitoring Only BEHAVIORAL

Participants will monitor sleep with sleep diary, but they will not receive feedback or any other information on to sleep.

Sleep monitoring only, then TAPAS

Eligibility Criteria

• Age: 13 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may not qualify if:

• Evidence of mental retardation, pervasive developmental disorder, or organic central nervous system disorder will exclude potential participants;
• unstable medical conditions;
• use of psychotropic medications or medications known to impact sleep;
• adolescent pregnancy;
• clinical levels of psychopathology, except for youth with a sole diagnosis of gender dysphoria;
• current sleep disorders except for sleep-onset insomnia;
• extreme evening preference; and
• Currently living \>1 hour outside of the greater Pittsburgh region.
• Sufficient Sleepers:
• ages 13-15;
• sufficient sleep (\>7.5 hours of sleep);
• willing/able to provide informed assent/consent.
• Evidence of mental retardation, pervasive developmental disorder, or organic central nervous system disorder;
• unstable medical conditions;
• use of psychotropic medications or medications known to impact sleep;

Sponsors & Collaborators

• University of Pittsburgh: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (2)

• Wescott DL, Goldstein TR, Wallace ML, Miller E, Buysse DJ, Harvey A, Suffoletto B, Rofey DL, Levenson JC. Effects of a single session intervention on actigraphy-measured sleep for adolescents with insufficient and irregular sleep: A randomized controlled trial. Sleep Health. 2026 Jan 19:S2352-7218(25)00280-3. doi: 10.1016/j.sleh.2025.12.008. Online ahead of print.

  PMID: 41558877 DERIVED

• Levenson JC, Goldstein TR, Wallace ML, Witt R, Harvey AG, Buysse D, Rofey DL, Suffoletto B, Miller E. A sleep promotion program for insufficient sleep among adolescents: a pilot feasibility randomized controlled trial. J Clin Sleep Med. 2025 Mar 1;21(3):529-541. doi: 10.5664/jcsm.11456.

  PMID: 39506293 DERIVED

MeSH Terms

Conditions

Parasomnias

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Jessica C Levenson, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychiatry and Pediatrics

Model Details: Among those with insufficient sleep, after participants are screened and receive universal education about sleep, those with insufficient sleep will be offered to participate in the randomized pilot trial. There are two arms in the randomized trial: TAPAS intervention, and wait-list control (monitoring only). The study will enroll n=50 participants in the Randomized Control Trial (RCT) to obtain full data on n=40 participants after attrition. Participants who obtain sufficient sleep will not be randomized, but will obtain the universal education only. Investigators anticipate enrolling n=35 adolescents with sufficient sleep.

Study Record Dates

• First Submitted: September 24, 2019
• First Posted: November 14, 2019
• Study Start: October 24, 2019
• Primary Completion: August 25, 2022
• Study Completion: August 25, 2022
• Last Updated: October 12, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)