NCT02333019

Brief Summary

While the U.S. teen birth rate is currently at its lowest level, it remains high in relation to other industrialized countries and continues to be a public health concern due to health risks for teen mothers and their babies, and associated social and economic costs. Parental monitoring, supervision, and open communication about sexual issues have been found to be protective factors for adolescent sexual activity and pregnancy. Our theoretically based Internet program for parents of pre-adolescent children aged 10-14, Let's Talk about Sex, is designed to build parental communication, knowledge, and attitudes to discuss sensitive topics with their child, including sexuality, pregnancy prevention, and preventing sexually transmitted illnesses (STIs). This age group of children was selected because parental communication about pregnancy and STI prevention will be most effective if initiated prior to, rather than after, the age when children commonly become sexually active. The "Let's Talk about Sex" program is grounded in behavior change theory and incorporates the use of video for behavioral modeling and emotional support.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
395

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2013

Shorter than P25 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

January 2, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 7, 2015

Completed
Last Updated

November 10, 2015

Status Verified

November 1, 2015

Enrollment Period

3 months

First QC Date

January 2, 2015

Last Update Submit

November 9, 2015

Conditions

Keywords

risk

Outcome Measures

Primary Outcomes (1)

  • Behavioral activation as measured by the Parent-Teen Sexual Risk Communication Scale

    Behavioral activation around discussions with their child was assessed with 9 items from the Parent-Teen Sexual Risk Communication Scale (Hutchinson, 2007). The items measure the type and quantity of information relayed in the parent-child conversation and were adapted to more precisely measure the content of the program (e.g., In general how much information have you shared with your daughter or son about human sexuality?). Response options were on a 5-point scale (1=none; 5=everything).

    8-week follow-up

Secondary Outcomes (5)

  • Behavioral intentions of parent to communicate with their child about sexuality and related topics

    4-week posttest and 8-week follow-up

  • Parents' perceived barriers in communicating with their children regarding pregnancy prevention and contraception

    4-week posttest and 8-week follow-up

  • Parents' perception of importance of communicating with their teen about sexuality and related topics

    4-week posttest and 8-week follow-up

  • Parents' knowledge of parent-teen communication about sexuality, birth control, and preventing sexually transmitted infections.

    4-week posttest and 8-week follow-up

  • Users' perception of program usability

    4-week posttest

Study Arms (2)

Let's Talk About Sex

EXPERIMENTAL

Participants assigned to the treatment condition viewed a multimedia web site designed to help parents of pre-adolescent children, aged 10 to 14 years old, build skills to communicate effectively about parental values and issues relating to sexuality, sex and relationships, and preventing pregnancy and sexually transmitted infections.

Behavioral: Let's Talk About Sex

Websites; preventing teen pregnancy

ACTIVE COMPARATOR

Participants assigned to the control condition were emailed urls for websites with information similar to the Let's Talk about Sex program. Parents were directed to the parents section of the National Campaign to Prevent Teen and Unplanned Pregnancy and children were directed to Nemours' KidsHealth website.

Behavioral: Websites; preventing teen pregnancy

Interventions

Multimedia web site to build parental skills in communicating with their pre-adolescnet child sex and relationships, pregnancy prevention, and risk of sexually transmitted infections.

Let's Talk About Sex

Two general web sites with information about preventing teen pregnancy

Websites; preventing teen pregnancy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Parent or guardian with a child 10-14 years of age
  • Parent / guardian must be over the age of 18
  • Child must live with the parent participating in the study at least 50% of the time

You may not qualify if:

  • Parents or guardians with a child not fitting within the specified age range
  • Parents or guardians whose child does not live with him/her at least 50% of the time
  • Parents or guardians younger than 18 years old; due to online nature of the evaluation, we were unable to verify parental consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Center for Applied Science

Eugene, Oregon, 97401, United States

Location

MeSH Terms

Conditions

Sexually Transmitted DiseasesCommunicationSexuality

Condition Hierarchy (Ancestors)

Communicable DiseasesInfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBehaviorSexual Behavior

Study Officials

  • Susan Schroeder, MPH, MCHES

    Oregon Center for Applied Science

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Scientist

Study Record Dates

First Submitted

January 2, 2015

First Posted

January 7, 2015

Study Start

January 1, 2013

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

November 10, 2015

Record last verified: 2015-11

Locations