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Sleeping Healthy/Living Healthy Development

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Columbia University

Status

Completed

Conditions

Psychological Stress
Sleep

Treatments

Behavioral: Sleeping Healthy/Living Healthy
Behavioral: Attention Control

Study type

Interventional

Funder types

Other

Identifiers

NCT04484649
AAAS9595

Details and patient eligibility

About

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.

Full 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.

Enrollment

61 patients

Sex

All

Ages

13 to 17 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

61 participants in 2 patient groups

Intervention
Experimental group
Description:
Sleeping Healthy/Living Healthy
Treatment:
Behavioral: Sleeping Healthy/Living Healthy
Control
Active Comparator group
Description:
Attention Control
Treatment:
Behavioral: Attention Control

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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