NCT01535651

Brief Summary

The investigators are exploring the use of short message service (text) messaging by cell phones to enhance the effects of the Teen Outreach Program, an effective teen pregnancy prevention program.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
852

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2011

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, 2011

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 15, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 20, 2012

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

May 17, 2018

Status Verified

May 1, 2018

Enrollment Period

3.7 years

First QC Date

February 15, 2012

Last Update Submit

May 14, 2018

Conditions

Pregnancy Prevention

Outcome Measures

Primary Outcomes (1)

  • pregnancy

    21 months

Secondary Outcomes (1)

  • school drop out

    21 months

Study Arms (2)

TOP Program plus Text messaging

EXPERIMENTAL

Boys and Girls Club members who participate in TOP over 9 months will receive regular text messages in addition to TOP

Behavioral: Teen Outreach Program with Media Enhancement (TOP4ME)

TOP Program alone

NO INTERVENTION

Boys and Girls Club participants will participate in TOP for 9 months

Interventions

Teen Outreach Program with Media Enhancement (TOP4ME)BEHAVIORAL

Persons participating in TOP will receive text messages weekly in addition to TOP

Also known as: Youth All Engaged! (YAE!)
TOP Program plus Text messaging

Eligibility Criteria

Age14 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • boys and girls club member in metro Denver, age 14-18

You may not qualify if:

  • non-english speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boys and Girls Clubs of Metro Denver

Denver, Colorado, 80204, United States

Location

Related Publications (1)

  • Devine S, Bull S, Dreisbach S, Shlay J. Enhancing a Teen Pregnancy Prevention Program with text messaging: engaging minority youth to develop TOP (R) Plus Text. J Adolesc Health. 2014 Mar;54(3 Suppl):S78-83. doi: 10.1016/j.jadohealth.2013.12.005.

    PMID: 24560081BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 15, 2012

First Posted

February 20, 2012

Study Start

September 1, 2011

Primary Completion

May 1, 2015

Study Completion

May 1, 2016

Last Updated

May 17, 2018

Record last verified: 2018-05

Locations

US(1)