Targeted Intervention for Insufficient Sleep Among Typically-Developing Adolescents

Sleep Disturbance Clinical Trial

— TAPAS  

Official title:

Targeted Intervention for Insufficient Sleep Among Typically-Developing Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04163003
• Other study ID #: STUDY19080033
• Secondary ID: K23HD087433
• Status: Completed
• Phase: N/A
• Start date: October 24, 2019
• Est. completion date: August 25, 2022

Study information

• Verified date: October 2022
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: August 25, 2022
• Est. primary completion date: August 25, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 15 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dyssomnias
• Parasomnias
• Sleep Deprivation
• Sleep Disturbance

Intervention

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

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Academic Functioning	Grades in School	4 weeks
Other	Attention	The Psychomotor Vigilance Test (PVT) is a computer-based test of vigilant attention, which is measured by reaction time in milliseconds.	4 weeks
Other	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
Other	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
Primary	Attrition	Participant attrition rate	4 weeks
Primary	Response Rate	Participant response rate to electronic intervention prompts	4 weeks
Primary	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
Primary	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
Primary	Sleep Diary Sleep Duration	Average sleep duration (in hours and minutes) as measured by sleep diary	4 weeks
Primary	Sleep Diary Sleep Timing	Average sleep timing as measured by sleep diary	4 weeks
Primary	Sleep Diary Weekend-Weekday Sleep Timing Differences	Difference in average weekend and weekday sleep timing as measured by sleep diary	4 weeks
Secondary	Actigraphy Sleep Duration	Average sleep duration (in hours and minutes) as measured by actigraphy	4 weeks
Secondary	Actigraphy Sleep Timing	Average sleep timing as measured by actigraphy	4 weeks
Secondary	Actigraphy Weekend-Weekday Sleep Timing Differences	Differences in average weekend and weekday sleep timing as measured by actigraphy	4 weeks