Clinical trial NCT05714943: Website for Adolescents About Pediatric Clinical Trials
Official title: Web-based Resource for Children and Adolescents About Clinical Research
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Chronic Illnesses, Multiple
Lead sponsor: Innovation Research & Training
Sponsor class: OTHER
First posted: 2023-02-06
Enrollment: 255
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of this study is to evaluate the effectiveness of DigiKnowIt News: Teen with parent-adolescent pairs.

Detailed description: Parent-adolescent pairs (N=180) will be recruited to participate in a randomized controlled trial. Parent consent and parent permission and youth assent will be sought. Participant pairs will be randomized into one of two study arms: intervention and wait-list control. All participants will complete a web-based pre-test questionnaire. Youth and parents in the intervention group will then receive access to DigiKnowIt News: Teen for one week. Approximately one week after completing the pre-test questionnaire, all participants will complete a web-based post-test questionnaire (the post-test for the intervention group will include Consumer Satisfaction Questions). Youth and parents in the wait-list control group will then receive access to DigiKnowIt News: Teen for one week. After one week, they will be asked to complete a Consumer Satisfaction Questionnaire.

Eligibility criteria: Inclusion Criteria:

* Adult participant is a parent or legal guardian of adolescent participant;
* Adolescent participant is within the ages of 12-17 years;
* Parent-adolescent pair has access to a computer or tablet with internet connection
* Parent-adolescent pair is fluent in English

Exclusion Criteria:

* Adolescent participant has previously participated in a clinical trial after kindergarten.

Primary outcomes:
measure: Change From Baseline in Adolescents' Knowledge About Clinical Trials at Week 1
timeFrame: Baseline and Week 1
measure: Change From Baseline in Adolescents' Attitudes About Clinical Trials at Week 1
timeFrame: Baseline and Week 1
measure: Change From Baseline in Adolescents' Beliefs About Clinical Trials at Week 1
timeFrame: Baseline and Week 1
measure: Change From Baseline in Adolescents' Self-efficacy to Communicate at Week 1
timeFrame: Baseline and Week 1
measure: Change From Baseline in Adolescents' Self-efficacy to Gather Information at Week 1
timeFrame: Baseline and Week 1
measure: Change From Baseline in Adolescents' Confidence for Participating in a Clinical Trial at Week 1
timeFrame: Baseline and Week 1
measure: Change From Baseline in Adolescents' Procedural Fears at Week 1
timeFrame: Baseline and Week 1
measure: Change From Baseline in Adolescents' Likelihood of Participation at Week 1
timeFrame: Baseline and Week 1
measure: Change From Baseline in Adolescents' Likelihood of Fear Preventing Participation at Week 1
timeFrame: Baseline and Week 1
measure: Change From Baseline in Adolescents' Familiarity With Clinical Trials at Week 1
timeFrame: Baseline and Week 1
measure: Change From Baseline in Adolescents' Willingness to Participate at Week 1
timeFrame: Baseline and Week 1
measure: Change From Baseline in Adolescents' Perceptions of Parent-adolescent Communication Quality at Week 1
timeFrame: Baseline and Week 1
measure: Change From Baseline in Parents' Attitudes About Clinical Trials at Week 1
timeFrame: Baseline and Week 1
measure: Change From Baseline in Parents' Beliefs About Clinical Trials at Week 1
timeFrame: Baseline and Week 1
measure: Change From Baseline in Parents' Likelihood of Participation at Week 1
timeFrame: Baseline and Week 1
measure: Change From Baseline in Parents' Likelihood of Fear Preventing Participation at Week 1
timeFrame: Baseline and Week 1
measure: Change From Baseline in Parents' Familiarity With Clinical Trials at Week 1
timeFrame: Baseline and Week 1
measure: Change From Baseline in Parents' Willingness to Participate at Week 1
timeFrame: Baseline and Week 1
measure: Change From Baseline in Parents' Perceptions of Parent-adolescent Communication Quality at Week 1
timeFrame: Baseline and Week 1
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: innovation Research & Training
state: North Carolina
Study officials:
affiliation: Innovation Research & Training
name: Alison Parker, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Innovation Research & Training
name: Tracy Scull, PhD
role: PRINCIPAL_INVESTIGATOR
References: