Website for Adolescents About Pediatric Clinical Trials

Innovation Research & Training

Status: Completed

Conditions: Healthy; Chronic Illnesses, Multiple

Treatments: Behavioral: DigiKnowIt News: Teen

Study type: Interventional

Funder types: Other

Identifiers

NCT05714943

Teensinresearch-SBIR-22-002

Details and patient eligibility

About

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

Full 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.

Enrollment: 255 patients

Sex: All

Ages: 12 to 17 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

255 participants in 2 patient groups

Educational website intervention

Experimental group

Description:

Participants will have access to an intervention between pre-test and post-test assessments. The intervention, DigiKnowIt News: Teen, is an educational website designed to teach youth (12-17 years) about pediatric clinical trials and give parents and youth resources for communication and shared decision-making about research.

Treatment:

Behavioral: DigiKnowIt News: Teen

Wait-List Control

No Intervention group

Description:

Participants will not have access to the educational website between the pre-test and post-test assessments. After completing the post-test questionnaires, participants in the wait-list control group will receive access to the intervention (DigiKnowIt News: Teen).