A Parent Child Program to Prevent Adolescent Pregnancy

NCT ID: NCT02333019

Last Updated: 2015-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

395 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2013-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

"Let's Talk about Sex" was designed to help parents talk to their 10- to 14-year old children about sex and relationships. The goal of the program for the parent was to build skills to communicate effectively with their children about parental values and about issues relating to sexuality, specifically by: a) increasing communication with their child about sexuality; b) increasing behavioral intentions to communicate; c) decreasing perceived barriers to communicating about sexuality; (d) increasing perceived sense of importance/motivation for communicating about sexuality; and e) increasing knowledge about risks of adolescent pregnancy and sexually transmitting infections (STIs). The goal of the intervention for the child was to increase child-parent communication about sexuality issues.

Program content was derived from the research literature; focus group findings, and input from professional consultants, experts in the field with extensive experience working with communication about sexuality. Modifications to content and program format were made based on iterative usability testing.

The parents' program was structured around five sessions, which guided the user through a topic-oriented experience of the content. The program used text, video narration, and video testimonials to present the intervention material. Emails were sent to users weekly for 8 weeks, with a link to a recommended session. Users could also browse the content freely as desired. Topics for parents included (1) Influencing your child's decisions about sex; (2) Understanding your own sexual values and beliefs; (3) Helping your child prepare for adolescence; (4) Preventing pregnancy and disease; and (5) Healthy relationships. Parents who responded to a values and beliefs quiz within the "Understanding your own sexual values and beliefs" section were presented with recommended articles tailored to their responses.

The child's intervention was structured as one session with four brief topics: (1) a whiteboard animation titled "How to talk to your parents about sex and not die of embarrassment"; (2) an article about bodily changes related to puberty; (3) a "What's most important to me" quiz; and (4) an article about healthy relationships.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Adolescent Pregnancy Sexually Transmitted Diseases Parental Communication Sexuality

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Let's Talk About Sex

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.

Group Type EXPERIMENTAL

Let's Talk About Sex

Intervention Type BEHAVIORAL

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.

Websites; preventing teen pregnancy

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.

Group Type ACTIVE_COMPARATOR

Websites; preventing teen pregnancy

Intervention Type BEHAVIORAL

Two general web sites with information about preventing teen pregnancy

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Let's Talk About Sex

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.

Intervention Type BEHAVIORAL

Websites; preventing teen pregnancy

Two general web sites with information about preventing teen pregnancy

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Oregon Center for Applied Science, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Susan Schroeder

Research Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Susan Schroeder, MPH, MCHES

Role: PRINCIPAL_INVESTIGATOR

Oregon Center for Applied Science

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Oregon Center for Applied Science

Eugene, Oregon, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R44HD048057

Identifier Type: NIH

Identifier Source: secondary_id

View Link

SBIR79RR-IIRR

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Tennessee Youth Prepared for Success
NCT06001892 RECRUITING NA
Latino Teen Pregnancy Prevention K23
NCT06105905 ENROLLING_BY_INVITATION NA