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NCT04484649 · ClinicalTrials.gov registry record · NA

Sleeping Healthy/Living Healthy Development

A NA study, sponsored by Columbia University.

Completed
Registry status
NA
Development phase
61
Enrollment target

NCT04484649 is a NA study that has completed, run by Columbia University. The registered enrollment target is 61 participants.

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The verdict

NCT04484649, a NA study, has completed, sponsored by Columbia University.

COMPLETED
Registry status
NA
Development phase
61 participants
Enrollment target

Study 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.

Interventions

  • BEHAVIORAL Attention Control
  • BEHAVIORAL Sleeping Healthy/Living Healthy

Trial Details

FieldValue
Enrollment Target 61 participants
Start Date 2021-10-12
Est. Completion 2022-06-07
Phase NA

Sponsor

Columbia University

958 total trials

What the Registry Record Tells You About NCT04484649

The ClinicalTrials.gov registry entry for NCT04484649 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 61 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Columbia University, which has 958 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Attention Control is the first listed.

NCT04484649 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT04484649 about?

NCT04484649 is a clinical study titled "Sleeping Healthy/Living Healthy Development". 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 p...

What is the current status of trial NCT04484649?

This trial is currently completed. It is a NA study. The enrollment target is 61 participants. The study started on 2021-10-12. Estimated completion is 2022-06-07.

What interventions are being tested in trial NCT04484649?

The interventions under investigation include: Attention Control (BEHAVIORAL), Sleeping Healthy/Living Healthy (BEHAVIORAL).

Who is sponsoring clinical trial NCT04484649?

This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.