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

Primary Purpose

Sleep Disturbance

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Targeted Approaches for Promoting Adolescent Sleep (TAPAS)
Sleep Monitoring Only
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Disturbance

Eligibility Criteria

13 Years - 15 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Pittsburgh

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

TAPAS

Sleep monitoring only, then TAPAS

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Attrition
Participant attrition rate
Response Rate
Participant response rate to electronic intervention prompts
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.
Participant Satisfaction
A locally-developed Treatment Satisfaction Questionnaire measures program satisfaction. Scores range from 18 to 75, with higher scores indicating greater satisfaction.
Sleep Diary Sleep Duration
Average sleep duration (in hours and minutes) as measured by sleep diary
Sleep Diary Sleep Timing
Average sleep timing as measured by sleep diary
Sleep Diary Weekend-Weekday Sleep Timing Differences
Difference in average weekend and weekday sleep timing as measured by sleep diary

Secondary Outcome Measures

Actigraphy Sleep Duration
Average sleep duration (in hours and minutes) as measured by actigraphy
Actigraphy Sleep Timing
Average sleep timing as measured by actigraphy
Actigraphy Weekend-Weekday Sleep Timing Differences
Differences in average weekend and weekday sleep timing as measured by actigraphy

Full Information

First Posted
September 24, 2019
Last Updated
October 10, 2022
Sponsor
University of Pittsburgh
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT04163003
Brief Title
Targeted Intervention for Insufficient Sleep Among Typically-Developing Adolescents
Acronym
TAPAS
Official Title
Targeted Intervention for Insufficient Sleep Among Typically-Developing Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
October 24, 2019 (Actual)
Primary Completion Date
August 25, 2022 (Actual)
Study Completion Date
August 25, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Disturbance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TAPAS
Arm Type
Experimental
Arm Description
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.
Arm Title
Sleep monitoring only, then TAPAS
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Targeted Approaches for Promoting Adolescent Sleep (TAPAS)
Other Intervention Name(s)
TAPAS
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Sleep Monitoring Only
Intervention Description
Participants will monitor sleep with sleep diary, but they will not receive feedback or any other information on to sleep.
Primary Outcome Measure Information:
Title
Attrition
Description
Participant attrition rate
Time Frame
4 weeks
Title
Response Rate
Description
Participant response rate to electronic intervention prompts
Time Frame
4 weeks
Title
Adherence
Description
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.
Time Frame
1 session
Title
Participant Satisfaction
Description
A locally-developed Treatment Satisfaction Questionnaire measures program satisfaction. Scores range from 18 to 75, with higher scores indicating greater satisfaction.
Time Frame
4 weeks
Title
Sleep Diary Sleep Duration
Description
Average sleep duration (in hours and minutes) as measured by sleep diary
Time Frame
4 weeks
Title
Sleep Diary Sleep Timing
Description
Average sleep timing as measured by sleep diary
Time Frame
4 weeks
Title
Sleep Diary Weekend-Weekday Sleep Timing Differences
Description
Difference in average weekend and weekday sleep timing as measured by sleep diary
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Actigraphy Sleep Duration
Description
Average sleep duration (in hours and minutes) as measured by actigraphy
Time Frame
4 weeks
Title
Actigraphy Sleep Timing
Description
Average sleep timing as measured by actigraphy
Time Frame
4 weeks
Title
Actigraphy Weekend-Weekday Sleep Timing Differences
Description
Differences in average weekend and weekday sleep timing as measured by actigraphy
Time Frame
4 weeks
Other Pre-specified Outcome Measures:
Title
Academic Functioning
Description
Grades in School
Time Frame
4 weeks
Title
Attention
Description
The Psychomotor Vigilance Test (PVT) is a computer-based test of vigilant attention, which is measured by reaction time in milliseconds.
Time Frame
4 weeks
Title
Affect
Description
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.
Time Frame
4 weeks
Title
Risk Behavior
Description
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
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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: ages 13 years, 0 months to 15 years, 11 months; able and willing to give informed assent to participate (with informed consent from parent); insufficient sleep (≤7.5 hours sleep on average weeknights); and weekend-weekday sleep timing shift >=1.5 hours. Inclusion criteria are not applicable for parents. Exclusion Criteria: 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: Inclusion Criteria: ages 13-15; sufficient sleep (>7.5 hours of sleep); willing/able to provide informed assent/consent. Exclusion Criteria: 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; 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessica C Levenson, PhD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Targeted Intervention for Insufficient Sleep Among Typically-Developing Adolescents

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