NCT04508569

Brief Summary

An evaluation of a promising Teen Pregnancy Prevention Curriculum, Big Decisions, in ninth grade students in three high schools in South Texas.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,170

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2019

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 7, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 11, 2020

Completed
Last Updated

August 11, 2020

Status Verified

August 1, 2020

Enrollment Period

3.3 years

First QC Date

August 7, 2020

Last Update Submit

August 7, 2020

Conditions

Teen Pregnancy Prevention

Outcome Measures

Primary Outcomes (1)

  • Use of condom or effective method of birth control last time you had sex

    Did you use a condom or effective method of birth control the last time you had sex?

    One year

Secondary Outcomes (2)

  • intention to use condom or birth control

    immediate post-test

  • Frequency of communication with parents about abstinence and sex

    immediate post-test

Study Arms (2)

Big Decisions

EXPERIMENTAL
Behavioral: Big Decisions

Youth Voices

ACTIVE COMPARATOR
Behavioral: Big Decisions

Interventions

Big DecisionsBEHAVIORAL

Big Decisions is a promising teen pregnancy prevention intervention that consists primarily of abstinence-plus sexual health education curriculum. The intended dosage for students is 10 classroom-based sexual health lessons.

Big DecisionsYouth Voices

Eligibility Criteria

Age13 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Must be in ninth grade and enrolled in a participating class at a participating high school

You may not qualify if:

  • Lack of consent or assent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Philliber Research and Evaluation

Accord, New York, 12404, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2020

First Posted

August 11, 2020

Study Start

September 1, 2016

Primary Completion

December 15, 2019

Study Completion

December 15, 2019

Last Updated

August 11, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)