Targeted Intervention for Insufficient Sleep Among Typically-Developing Adolescents
Condition: Sleep Disturbance
MeSH terms: Dyssomnias; Parasomnias; Sleep Deprivation
Study type: Interventional

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.
    

Intervention name(s): Targeted Approaches for Promoting Adolescent Sleep (TAPAS); Sleep Monitoring Only
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; Participants will monitor sleep with sleep diary, but they will not receive feedback or any other information on to sleep.
Other intervention name(s): TAPAS
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention 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)
Primary purpose: Treatment