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Smartphone tool helps native teens prevent alcohol-related birth defects

NCT ID NCT04376346

Prevention Sponsor: University of Colorado, Denver Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a culturally adapted mobile health program called Mobile CHOICES to help urban American Indian and Alaska Native young women (ages 16-20) avoid drinking alcohol during pregnancy. The goal was to reduce the risk of Fetal Alcohol Spectrum Disorders, which cause lifelong disabilities. Researchers recruited 439 participants through social media and measured whether they reduced alcohol use and used effective contraception.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

439 people

The number who actually took part.

Started

Aug 2021

Finished

Feb 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

16 to 20 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Identifies as American Indian or Alaska Native (AIAN) * Biologically female * 16-20 years old * Not pregnant * Not living in tribal reservation or in an Alaska Native Village * Live in an urban area that is at least 50,000 in population * Not breastfeeding * Has an email account * Has a smart phone Exclusion Criteria: * Age 15 or younger, and 21 or older * Biologically male * Not AIAN * Pregnant or breastfeeding women * People who live on a tribal land or in communities with less than 50,000 in population * Reside in the state of Alaska (until study obtains local IRB approval)

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Conditions

The condition(s) this trial relates to.

fetal alcohol spectrum disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Alcohol exposed pregnancy

Contacts and locations

Locations

  • University of Colorado- Anschutz Medical Campus

    Aurora, Colorado, 80045, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.