Targeted Intervention for Insufficient Sleep Among Typically-Developing Adolescents (TAPAS)

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.

Study Overview

• Status: Completed
• Conditions: Sleep Disturbance
• Intervention / Treatment: Behavioral: Targeted Approaches for Promoting Adolescent Sleep (TAPAS); Behavioral: Sleep Monitoring Only

Detailed Description

General Description:

This study has two sub-studies: one for youth who experience behaviorally insufficient sleep syndrome (BISS) and one for youth who obtain sufficient sleep. This includes a randomized controlled trial for youth who obtain insufficient sleep (BISS), and a universal education (UE) only intervention for youth who obtain sufficient sleep.

All participants will complete a pre-consent screen. Those with sufficient sleep will complete consent/assent and a full screening assessment, and they will watch a sleep education video (UE). If eligible for the sufficient sleeper study, the full screening assessment will serve as a baseline assessment as well. Participants will complete a follow-up assessment about one month later.

Those who pre-screen as insufficient sleepers will complete consent/assent, complete a full screening process, and watch a sleep education video (UE). Those who remain eligible after the full screening process will complete a baseline assessment. Then, youth will be randomized to the TAPAS intervention or to a wait-list control (monitoring only). After completing the post-period 1 follow-up assessment, those in the wait-list control group will switch to the other arm, via a cross-over design. Participants in the intervention-first group will continue to receive the intervention iin Period 2 after post-period 1. After this period, participants will complete the post-period 2 follow-up assessment.

Detailed Description:

Participants. Youth ages 13-15 will be recruited through various methods (e.g., social media advertising, University research registry, flyers, email listservs and online magazines, and from the waiting room of the Children's Hospital of Pittsburgh Center for Adolescent and Young Adult Health (CAYAH)). Among those screened, the investigators will deliver universal education about sleep and conduct baseline and follow-up assessments among n=35 sufficient sleepers. Investigators will randomize n=50 with insufficient sleep to the TAPAS intervention or wait-list control (monitoring only). Overall, investigators plan to collect complete data on n=40 participants, after attrition.

Baseline assessments will include: measures of sleep (sleep diary and actigraphy), academic functioning, attention, affect, motivation, and risk behavior.

TAPAS Intervention. Program goals are to increase knowledge about healthy sleep practices, to increase sleep duration by going to bed earlier (sleep extension), and to increase regularity in sleep timing over the week by limiting oversleeping on the weekends. During the 45-60 minute intervention session, the youth and clinician will discuss the youth's sleep timing and quality and explore the youth's attitudes and social influences on sleep. The clinician will develop discrepancies between current sleep behavior and the youth's values and goals.

It is proposed that the 4-8-week text messaging/web-based portion of the intervention will begin immediately after the clinician session. Participants will receive twice-weekly summaries of their sleep based on diary entries. Participants will then be asked via the web if they'd like to modify their sleep, providing them with autonomy in their answer. Investigators will rely on strategies for extending and regularizing sleep.

Wait-List Control (monitoring only) Condition. The wait-list is proposed to last half the duration as the targeted intervention (4 vs 8 weeks). Participants will monitor sleep with the sleep diary, but they will not receive feedback or any other information on their sleep.

Participants will repeat the baseline assessments and 7 days of actigraphy at the end of Period 1 and at the end of Period 2 (only those randomized to Wait-List Control will cross-over to TAPAS intervention for Period 2).

Follow-up assessments will include: measures of sleep (sleep diary and actigraphy), academic functioning, attention, affect, motivation, and risk behavior.

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 15 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

All participants will be excluded if they live more than roughly an hour's drive from Pittsburgh, Pennsylvania (PA).

Insufficient Sleepers:

Investigators will screen, deliver universal education (UE), and offer participation to all participants:

1. ages 13 years, 0 months to 15 years, 11 months;
2. able and willing to give informed assent to participate (with informed consent from parent);
3. insufficient sleep (≤7.5 hours sleep on average weeknights); and
4. weekend-weekday sleep timing shift >=1.5 hours.

Inclusion criteria are not applicable for parents.

Exclusion Criteria:

1. Evidence of mental retardation, pervasive developmental disorder, or organic central nervous system disorder will exclude potential participants;
2. unstable medical conditions;
3. use of psychotropic medications or medications known to impact sleep;
4. adolescent pregnancy;
5. clinical levels of psychopathology, except for youth with a sole diagnosis of gender dysphoria;
6. current sleep disorders except for sleep-onset insomnia;
7. extreme evening preference; and
8. Currently living >1 hour outside of the greater Pittsburgh region.

Sufficient Sleepers:

Inclusion Criteria:

1. ages 13-15;
2. sufficient sleep (>7.5 hours of sleep);
3. willing/able to provide informed assent/consent.

Exclusion Criteria:

1. Evidence of mental retardation, pervasive developmental disorder, or organic central nervous system disorder;
2. unstable medical conditions;
3. use of psychotropic medications or medications known to impact sleep;
4. adolescent pregnancy;
5. clinical levels of psychopathology, except for youth with a sole diagnosis of gender dysphoria;
6. current sleep disorders except for sleep-onset insomnia;
7. extreme evening preference; and
8. Currently living >1 hour outside of the greater Pittsburgh region.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: TAPAS; 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); 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.; Other Names: TAPAS
EXPERIMENTAL: Sleep monitoring only, then TAPAS; 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); 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.; Other Names: TAPAS; Behavioral: Sleep Monitoring Only; Participants will monitor sleep with sleep diary, but they will not receive feedback or any other information on to sleep.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Actigraphy Sleep Duration	Average sleep duration (in hours and minutes) as measured by actigraphy	4 weeks
Actigraphy Sleep Timing	Average sleep timing as measured by actigraphy	4 weeks
Actigraphy Weekend-Weekday Sleep Timing Differences	Differences in average weekend and weekday sleep timing as measured by actigraphy	4 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Academic Functioning	Grades in School	4 weeks
Attention	The Psychomotor Vigilance Test (PVT) is a computer-based test of vigilant attention, which is measured by reaction time in milliseconds.	4 weeks
Affect	The Mood and Feelings Questionnaire (MFQ) is a measure or depressive symptoms. Scores range from 0 to 66, with higher scores indicating greater depressive symptoms.	4 weeks
Risk Behavior	The Balloon Analogue Risk Task (BART) is a computerized measure of risk-taking behavior. In the task, the participant can earn money by pumping up balloons. Each pump incrementally results in a larger balloon and an associated increase in earn money. However, popping a balloon results in loss of money. Each balloon pops at a different point. The primary outcome is average number of pumps on unexploded balloons, with higher scores indicative of greater risk-taking propensity	4 weeks

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: Jessica C Levenson, PhD, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 24, 2019
• Primary Completion (ACTUAL): August 25, 2022
• Study Completion (ACTUAL): August 25, 2022

Study Registration Dates

• First Submitted: September 24, 2019
• First Submitted That Met QC Criteria: November 11, 2019
• First Posted (ACTUAL): November 14, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 12, 2022
• Last Update Submitted That Met QC Criteria: October 10, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Wake Disorders; Neurologic Manifestations; Dyssomnias; Parasomnias; Sleep Deprivation
• Other Study ID Numbers: STUDY19080033; K23HD087433 (NIH)

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