NCT03655951

Brief Summary

The goal of this efficacy study is to evaluate how different web-based resources affect parents' and children's sexual health knowledge; attitudes, efficacy, intentions, and behaviors about parent-adolescent communication; attitudes about media messages; and media message deconstruction skills. Parent consumer satisfaction with the resources will also be assessed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
730

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2018

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 13, 2018

Completed
2 days until next milestone

Study Start

First participant enrolled

August 15, 2018

Completed
20 days until next milestone

First Posted

Study publicly available on registry

September 4, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2019

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

November 10, 2020

Completed
Last Updated

November 10, 2020

Status Verified

October 1, 2020

Enrollment Period

10 months

First QC Date

August 13, 2018

Results QC Date

April 15, 2020

Last Update Submit

October 18, 2020

Conditions

Outcome Measures

Primary Outcomes (4)

  • Change in Parent Reported Frequency of Parent-child Communication About Relationships, Sex, and Media From Pretest to Posttest

    Parent questionnaires ask participants how frequently they engage in parent-child communication about relationships, sex, and media. (1. Never; 2. Rarely; 3. Sometimes; 4. Often). Higher numbers represent a better outcome.

    1) pretest questionnaire; 2) posttest questionnaire - 4 weeks after pretest

  • Change in Child Reported Frequency of Parent-child Communication About Relationships, Sex, and Media From Pretest to Posttest

    Child questionnaires ask participants how frequently they engage in parent-child communication about relationships, sex, and media. (1. Never; 2. Rarely; 3. Sometimes; 4. Often). Higher numbers represent a better outcome.

    1) pretest questionnaire; 2) posttest questionnaire - 4 weeks after pretest

  • Change in Parent Reported Frequency of Parent-child Communication About Relationships, Sex, and Media From Pretest to Follow-up

    Parent questionnaires ask participants how frequently they engage in parent-child communication about relationships, sex, and media. (1. Never; 2. Rarely; 3. Sometimes; 4. Often). Higher numbers represent a better outcome.

    1) pretest questionnaire; 3) follow-up questionnaire - 24 weeks after pretest

  • Change in Child Reported Frequency of Parent-child Communication About Relationships, Sex, and Media From Pretest to Follow-up.

    Child questionnaires ask participants how frequently they engage in parent-child communication about relationships, sex, and media. (1. Never; 2. Rarely; 3. Sometimes; 4. Often). Higher numbers represent a better outcome.

    1) pretest questionnaire; 2) follow-up questionnaire - 24 weeks after pretest

Secondary Outcomes (74)

  • Change in Parental Perceived Importance of Parent-child Communication About Relationship and Sexual Health From Pretest to Posttest

    1) pretest questionnaire; 2) posttest questionnaire - 4 weeks after pretest

  • Change in Parent Level of Comfort With Parent-child Communication About Relationship and Sexual Health From Pretest to Posttest

    1) pretest questionnaire; 2) posttest questionnaire - 4 weeks after pretest

  • Change in Parent Reservations About Parent-child Communication About Relationship and Sexual Health From Pretest to Posttest

    1) pretest questionnaire; 2) posttest questionnaire - 4 weeks after pretest

  • Change in Parent Outcome Expectancies Related to Communicating With Their Child About Relationship and Sexual Health From Pretest to Posttest

    1) pretest questionnaire; 2) posttest questionnaire - 4 weeks after pretest

  • Change in Parent Self-efficacy to Engage in Communication With Their Child About Relationship and Sexual Health From Pretest to Posttest

    1) pretest questionnaire; 2) posttest questionnaire - 4 weeks after pretest

  • +69 more secondary outcomes

Study Arms (2)

Resource 1

EXPERIMENTAL

Web-based resource on adolescent sexual health

Behavioral: Web-based resource on adolescent sexual health

Resource 2

ACTIVE COMPARATOR

Alternate web-based resource on adolescent sexual health

Behavioral: Alternate web-based resource on adolescent sexual health

Interventions

Web-based resource on adolescent sexual health than the intervention.

Resource 1

This is a different web-based resource on adolescent sexual health than the intervention.

Resource 2

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • parent or legal guardian of a child in 7th, 8th, or 9th grade

You may not qualify if:

  • not fluent in English
  • does not have access to internet to complete study tasks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

innovation Research & Training

Durham, North Carolina, 27707, United States

Location

MeSH Terms

Conditions

Sexual BehaviorCommunication

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

Title
Dr. Tracy Scull
Organization
innovation Research & Training

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
Outcomes Assessor and Care Provider - NA This is a web-based study.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2018

First Posted

September 4, 2018

Study Start

August 15, 2018

Primary Completion

June 20, 2019

Study Completion

June 20, 2019

Last Updated

November 10, 2020

Results First Posted

November 10, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations