Clinical trial NCT04163003: Targeted Intervention for Insufficient Sleep Among Typically-Developing Adolescents
Official title: Targeted Intervention for Insufficient Sleep Among Typically-Developing Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Disturbance
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2019-11-14
Enrollment: 82
Sex: ALL
Minimum age (years): 13
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: TREATMENT

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.

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:

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.

Primary outcomes:
measure: Attrition
timeFrame: 4 weeks
measure: Response Rate
timeFrame: 4 weeks
measure: Adherence
timeFrame: 1 session
measure: Participant Satisfaction
timeFrame: 4 weeks
measure: Sleep Diary Sleep Duration
timeFrame: 4 weeks
measure: Sleep Diary Sleep Timing
timeFrame: 4 weeks
measure: Sleep Diary Weekend-Weekday Sleep Timing Differences
timeFrame: 4 weeks
Secondary outcomes:
measure: Actigraphy Sleep Duration
timeFrame: 4 weeks
measure: Actigraphy Sleep Timing
timeFrame: 4 weeks
measure: Actigraphy Weekend-Weekday Sleep Timing Differences
timeFrame: 4 weeks
Other outcomes:
measure: Academic Functioning
timeFrame: 4 weeks
measure: Attention
timeFrame: 4 weeks
measure: Affect
timeFrame: 4 weeks
measure: Risk Behavior
timeFrame: 4 weeks
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Jessica C Levenson, PhD
role: PRINCIPAL_INVESTIGATOR
References: