Sleeping Healthy/Living Healthy Development

NCT ID: NCT04484649

Last Updated: 2024-09-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-12
• Study Completion Date: 2022-06-07

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.

Detailed Description

Poor sleep quality, which contributes to impaired functioning, is elevated in urban, ethnic/racial minority adolescents due, in part, to poor sleep hygiene. Despite successful sleep hygiene interventions in younger children, none focus on adolescents, a group with unique developmental needs. Urban adolescents face unique contextual stressors, which may contribute to ineffective use of sleep hygiene behaviors. Mind-body integrative (MBIH) approaches (e.g. yoga, meditation) improve sleep quality in adults, but are rarely applied to adolescents. MBIH has been shown to reduce stress among adolescents. Taken together, this suggests that integrating MBIH with sleep hygiene strategies has the potential for a synergistic effect on improving sleep quality, yet no interventions concurrently use MBIH and sleep hygiene with adolescents.

Conditions

Sleep; Psychological Stress

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Intervention

Sleeping Healthy/Living Healthy

Group Type: EXPERIMENTAL

Sleeping Healthy/Living Healthy

Intervention Type: 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.

Control

Attention Control

Group Type: ACTIVE_COMPARATOR

Attention Control

Intervention Type: 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.

Interventions

Sleeping Healthy/Living Healthy

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 Type: BEHAVIORAL

Attention Control

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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?).

Exclusion Criteria

• 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.

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Samantha Garbers-Adams, PhD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Columbia University Irving Medical Center

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

AAAS9595

Identifier Type: -

Identifier Source: org_study_id