Sleeping Healthy/Living Healthy Development

NCT04484649 | Completed Results

• 1 other identifier: AAAS9595
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot study will: (1) develop Sleeping Healthy/Living Healthy, a school-based health center (SBHC) intervention that combines MBIH and sleep hygiene strategies to improve sleep quality in urban adolescents with poor sleep quality; (2) evaluate the feasibility and acceptability of intervention procedures; and (3) assess the preliminary intervention effects on sleep quality in urban adolescents. This study includes a development phase and a pilot individually-randomized group treatment (IRGT) phase. In Year 1, the investigators will develop the novel integrated intervention using an iterative participatory design process. In Year 2, the investigators will conduct an IRGT trial with 60 adolescents with insufficient sleep recruited from two SBHCs in New York City. Adolescents will be randomized 1:1 to receive the intervention or an attention control of equal intensity and duration. Process evaluation interviews guided by a rigorous fidelity framework with adolescents and with SBHC providers and personnel will be conducted to obtain feedback regarding intervention procedures.

Conditions

Sleep; Psychological Stress

Outcome Measures

Primary Outcomes (9)

• Average Sleep Duration (Past 2 Weeks)

  Measured using actigraphy. Measured in minutes.

  Baseline (Day 0)

• Average Sleep Duration (Past 2 Weeks)

  Measured with actigraphy. Measured in minutes.

  Immediate Post (up to 7 weeks after baseline)

• Average Sleep Duration (Past 2 Weeks)

  Measured in actigraphy. Measured in minutes.

  Follow-up (up to 2.5 months)

• Sleep Fragmentation - Sleep Efficiency (%) (Past Month)

  Represented as a percentage. Sleep efficiency = (# hours slept/# hours in bed) X 100% Sleep efficiency can range from 0-100%, with higher sleep efficiency representing better sleep. The numerator and denominator will be measured through actigraphy.

  Baseline (Day 0)

• Sleep Fragmentation - Sleep Efficiency (%) (Past Month)

  Represented as a percentage. Sleep efficiency = (# hours slept/# hours in bed) X 100% Sleep efficiency can range from 0-100%, with higher sleep efficiency representing better sleep. The numerator and denominator will be measured through actigraphy.

  Immediate Post (up to 7 weeks after baseline)

• Sleep Fragmentation - Sleep Efficiency (%) (Past Month)

  Represented as a percentage. Sleep efficiency = (# hours slept/# hours in bed) X 100% Sleep efficiency can range from 0-100%, with higher sleep efficiency representing better sleep. The numerator and denominator will be measured through actigraphy.

  Follow-up (up to 2.5 months)

• Sleep Fragmentation - Number of Sleep Disruptions (Past Month)

  Number of sleep disruptions (number of times awakened) per night (mean, in past month): measured using actigraphy.

  Baseline (Day 0)

• Sleep Fragmentation - Number of Sleep Disruptions (Past Month)

  Number of sleep disruptions (number of times awakened) per night (mean, in past month): measured using actigraphy.

  Immediate Post (up to 7 weeks after baseline)

• Sleep Fragmentation - Number of Sleep Disruptions (Past Month)

  Number of sleep disruptions (number of times awakened) per night (mean, in past month): measured using actigraphy.

  Follow-up (up to 2.5 months)

Secondary Outcomes (18)

• Score on Pittsburgh Sleep Quality Index (PSQI Global Score)

  Baseline (Day 0)

• Score on Pittsburgh Sleep Quality Index (PSQI Global Score)

  Immediate Post (up to 7 weeks after baseline)

• Score on Pittsburgh Sleep Quality Index (PSQI Global Score)

  Follow-up (up to 2.5 months)

• Score on the Perceived Stress Scale (PSS)

  Baseline (Day 0)

• Score on the Perceived Stress Scale (PSS)

  Immediate Post (up to 7 weeks after baseline)

Study Arms (2)

Intervention

EXPERIMENTAL

Sleeping Healthy/Living Healthy

Behavioral: Sleeping Healthy/Living Healthy

Control

ACTIVE COMPARATOR

Attention Control

Behavioral: Attention Control

Interventions

Sleeping Healthy/Living Healthy BEHAVIORAL

Sleeping Healthy/Living Healthy will be a school based health center (SBHC)-based intervention integrating mind-body integrative health (MBIH) and sleep hygiene strategies to improve sleep quality in urban adolescents. The Sleeping Healthy/Living Healthy intervention content and format will be determined in a Development Phase 1. The investigator anticipates the intervention will consist of two group and two one-on-one sessions. The intervention will be grounded in social-cognitive theory and use motivational interviewing to support MBIH and sleep hygiene strategies. Sessions will be delivered once per week by SBHC providers and health educators.

Intervention

Attention Control BEHAVIORAL

The Attention Control Intervention condition will meet the requirements for a comparison treatment for testing behavioral interventions - equivalent in contact time, credible and interesting, and exert limited treatment effects. In the same number of sessions and format as the Sleeping Healthy/Living Healthy intervention (anticipated to be two group and two one-on-one sessions delivered once per week by SBHC providers and health educators), the study will teach participants about sleep and other health topics relevant to adolescents (e.g., nutrition, injury prevention) devoid of the MBIH elements in our integrated intervention.

Control

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Age 13.0 -17.9;
• Grade 9 - 11;
• Currently enrolled as a patient in one of the participating SBHCs; and
• Report sleep duration \< 8 hours (below the minimally recommended number of hours of sleep for this age group through the following questions: What time do you: a) usually fall asleep on weekdays and b) usually wake up on weekdays?).

You may not qualify if:

• Report of prior diagnosis of a sleep disorder, such as sleep disordered breathing, restless leg syndrome, or periodic limb movement;
• Significant developmental delay and/or severe psychiatric or medical conditions that preclude completion of study procedures or confound analyses; or
• Not capable of communicating (reading, speaking, writing) in English.

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Samantha Garbers-Adams, PhD
• Organization: Columbia University Irving Medical Center

svg2108@cumc.columbia.edu

212-305-0123

Study Officials

• Samantha Garbers-Adams, PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2020
• First Posted: July 23, 2020
• Study Start: October 12, 2021
• Primary Completion: June 7, 2022
• Study Completion: June 7, 2022
• Last Updated: September 20, 2024
• Results First Posted: September 20, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)