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NCT04097496 · ClinicalTrials.gov registry record · NA

Effects of ACT OUT! Social Issue Theater on Youth and Adolescents

A NA study, sponsored by Indiana University.

Terminated
Registry status
NA
Development phase
1,537
Enrollment target

NCT04097496: Clinical Trial NA study, sponsored by Indiana University.

NCT04097496 is a NA study that was terminated before completion, run by Indiana University. The registered enrollment target is 1,537 participants, roughly in line with the 1,404-participant average among 58,714 other NA trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04097496, a NA study, was terminated before completion, sponsored by Indiana University.

TERMINATED
Registry status
NA
Development phase
1,537 participants
Enrollment target

Study Summary

The ACT OUT! Trial is designed as a proof-of-concept, cluster, randomized, superiority trial with two parallel groups. Although the unit of measurement is student, the unit of randomization is classroom, stratified by school. For each grade, an even number of classrooms will be selected from each school; half of the selected classrooms will be randomly assigned to intervention arm, whereas the other half will be assigned to control arm. This way, sociodemographic and school-level factors will be made approximately comparable between intervention and control arms.

Primary Outcome

Computed from the Delaware Social Emotional Competency Scale (DSECS-S). The score is averaged from Likert-type data (e.g., one overall score will be computed from 12 questions). The score ranges from '1' to '4' - some items will be reverse coded, so that a '4' is consistently the optimal score across questions and for the total scale value.

Interventions

  • BEHAVIORAL Act Out! Intervention

Trial Details

FieldValue
Enrollment Target 1,537 participants
Start Date 2019-10-16
Est. Completion 2020-03-15
Phase NA
Indiana University

890 total trials

Why NCT04097496 stopped before completion

NCT04097496 is an interventional study that assigns participants to a tested intervention. Its 1,537 participants enrollment target places it among the larger protocols in the corpus, roughly in line with the 1,404-participant average among 58,714 other NA trials with a reported enrollment target.

The record links to 0 conditions, and to 1 intervention - of which Act Out! Intervention is the first listed.

NCT04097496 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04097496 about?

NCT04097496 is a clinical study titled "Effects of ACT OUT! Social Issue Theater on Youth and Adolescents". The ACT OUT! Trial is designed as a proof-of-concept, cluster, randomized, superiority trial with two parallel groups. Although the unit of measurement is student, the unit of randomization is classroom, stratified by school. For each grade, an even number of classrooms will be selected from each sc...

What is the current status of trial NCT04097496?

This trial is currently terminated. It is a NA study. The enrollment target is 1,537 participants. The study started on 2019-10-16. Estimated completion is 2020-03-15.

What interventions are being tested in trial NCT04097496?

The interventions under investigation include: Act Out! Intervention (BEHAVIORAL).

Who is sponsoring clinical trial NCT04097496?

This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04097496's enrollment target sits among peer trials

1,537 65th of 2000 higher than 1,936 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04097496, the US trial registry maintained by the National Library of Medicine. NCT04097496 (large enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.