Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Eugene, Oregon 97401


Purpose:

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.


Study summary:

"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.


Criteria:

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


Study is Available At:


Original ID:

SBIR79RR-IIRR


NCT ID:

NCT02333019


Secondary ID:

R44 HD048057


Study Acronym:

PPP_2


Brief Title:

A Parent Child Program to Prevent Adolescent Pregnancy


Official Title:

A Parent Child Program to Prevent Adolescent Pregnancy


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Oregon Center for Applied Science, Inc.


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: E


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

395


Enrollment Type:

Actual


Overall Contact Information

Official Name:Susan Schroeder, MPH, MCHES
Principal Investigator
Oregon Center for Applied Science

Study Dates

Start Date:January 2013
Completion Date:April 2013
Completion Type:Actual
Primary Completion Date:April 2013
Primary Completion Type:Actual
Verification Date:November 2015
Last Changed Date:November 9, 2015
First Received Date:January 2, 2015

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Users' perception of program usability
Time Frame:4-week posttest
Safety Issues:False
Description:At posttest (T2), treatment participants completed an 11-item questionnaire from the Action-WAMMI (Chambers et al., 2002) assessing ease of use and experience in the program. Users were asked to what degree they agreed or disagreed with program use and sa
Outcome Type:Secondary Outcome
Measure:Parents' knowledge of parent-teen communication about sexuality, birth control, and preventing sexually transmitted infections.
Time Frame:4-week posttest and 8-week follow-up
Safety Issues:False
Description:A 10-item true-false scale and 5 multiple-choice items were developed from program content to assess parents' knowledge of parent-teen communication about sexuality, birth control, and preventing STIs. The total number of correct items was divided by the
Outcome Type:Secondary Outcome
Measure:Parents' perception of importance of communicating with their teen about sexuality and related topics
Time Frame:4-week posttest and 8-week follow-up
Safety Issues:False
Description:Attitudes and beliefs around importance/motivation were assessed with a 6-item scale developed from concepts taught in the program pertaining to parents' sense of importance or motivation for communicating with their teen about sexuality (e.g., It is extr
Outcome Type:Secondary Outcome
Measure:Parents' perceived barriers in communicating with their children regarding pregnancy prevention and contraception
Time Frame:4-week posttest and 8-week follow-up
Safety Issues:False
Description:Attitudes and beliefs around barriers were assessed with a 16- item scale developed by Jaccard et al. (2000) to measure beliefs, attitudes, and perceived barriers to parents communicating with children regarding pregnancy prevention and contraception. Ite
Outcome Type:Secondary Outcome
Measure:Behavioral intentions of parent to communicate with their child about sexuality and related topics
Time Frame:4-week posttest and 8-week follow-up
Safety Issues:False
Description:Seven items measuring parental intentions to talk with their child about sexuality, relationships, dating, preventing pregnancy and STSIs were derived from the content of the program (e.g., How likely is it that you will talk to your child about your valu
Outcome Type:Primary Outcome
Measure:Behavioral activation as measured by the Parent-Teen Sexual Risk Communication Scale
Time Frame:8-week follow-up
Safety Issues:False
Description: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 an

Study Interventions

Intervention Type:Behavioral
Name:Let's Talk About Sex
Description: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.
Arm Name:Let's Talk About Sex
Intervention Type:Behavioral
Name:Websites; preventing teen pregnancy
Description:Two general web sites with information about preventing teen pregnancy
Arm Name:Websites; preventing teen pregnancy

Study Arms

Study Arm Type:Active Comparator
Arm Name:Websites; preventing teen pregnancy
Description: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.
Study Arm Type:Experimental
Arm Name:Let's Talk About Sex
Description: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.

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Oregon Center for Applied Science, Inc.

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.