Clinical trial NCT02333019: A Parent Child Program to Prevent Adolescent Pregnancy
Official title: A Parent Child Program to Prevent Adolescent Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adolescent Pregnancy
Sexually Transmitted Diseases
Parental
Communication
Sexuality
Keywords: risk
Lead sponsor: Oregon Center for Applied Science, Inc.
Sponsor class: INDUSTRY
First posted: 2015-01-07
Enrollment: 395
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

Detailed description: "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.

Eligibility 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

Primary outcomes:
measure: Behavioral activation as measured by the Parent-Teen Sexual Risk Communication Scale
timeFrame: 8-week follow-up
Secondary outcomes:
measure: Behavioral intentions of parent to communicate with their child about sexuality and related topics
timeFrame: 4-week posttest and 8-week follow-up
measure: Parents' perceived barriers in communicating with their children regarding pregnancy prevention and contraception
timeFrame: 4-week posttest and 8-week follow-up
measure: Parents' perception of importance of communicating with their teen about sexuality and related topics
timeFrame: 4-week posttest and 8-week follow-up
measure: Parents' knowledge of parent-teen communication about sexuality, birth control, and preventing sexually transmitted infections.
timeFrame: 4-week posttest and 8-week follow-up
measure: Users' perception of program usability
timeFrame: 4-week posttest
Other outcomes:
Locations:
city: Eugene
country: United States
facility: Oregon Center for Applied Science
state: Oregon
Study officials:
affiliation: Oregon Center for Applied Science
name: Susan Schroeder, MPH, MCHES
role: PRINCIPAL_INVESTIGATOR
References: