Sleeping Healthy/Living Healthy Development

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

Interventions

BEHAVIORAL

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.

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.

Sponsors & Collaborators

• Columbia University

  lead OTHER

Principal Investigators

• Samantha Garbers-Adams, PhD · Columbia University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

13 Years

Max Age

17 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-10-12

Primary Completion

2022-06-07

Completion

2022-06-07

Countries

• United States

Study Locations