Web-based Resource for Children and Adolescents About Clinical Research

• Sponsor: Innovation Research & Training (Other)
• Overall Status: Completed
• CT.gov ID: NCT04448210
• Collaborator: (none)
• Enrollment: 42
• Location: 1
• Arms: 2
• Actual Duration (Months): 1.1
• Patients Per Site Per Month: 38.7

Study Details

Study Description

Brief Summary

The overall aims of this project are to: 1) create a developmentally appropriate interactive educational website for adolescents called DigiKnowIt News: Teen, and 2) examine the feasibility of DigiKnowIt News: Teen in a small randomized control trial with adolescents.

Condition or Disease	Intervention/Treatment	Phase
Healthy; Chronic Illnesses, Multiple	Behavioral: DigiKnowIt News: Teen	N/A

Detailed Description

Youth (N=30) will be recruited to participate in the feasibility study. Parent permission and youth assent will be sought. Participants 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 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 youth in the intervention group will also include Consumer Satisfaction Questions). Youth in the wait-list control group will then receive access to DigiKnowIt News: Teen for one week. After one week, they will complete a Consumer Satisfaction Questionnaire.

Study Design

• Study Type: Interventional
• Actual Enrollment: 42 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Health Services Research
• Official Title: Web-based Resource for Children and Adolescents About Clinical Research
• Actual Study Start Date: Jun 30, 2020
• Actual Primary Completion Date: Jul 19, 2020
• Actual Study Completion Date: Aug 2, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Educational website intervention The intervention is an educational website designed to teach youth (12-17 years) about pediatric clinical trials.	Behavioral: DigiKnowIt News: Teen; Teens will interact with a multimedia educational website that will teach them about pediatric clinical trials including topics such as participant rights and safety, benefits and costs to participating in a study, and different types of procedures used in trials.
No Intervention: Wait-list control The wait-list control group did not receive the intervention between the pre-test and post-test assessments. After completing the post-test questionnaire, youth in the wait-list control group had the option to receive access to the intervention (DigiKnowIt News).

Outcome Measures

Primary Outcome Measures

1. Knowledge Scores at 1 Week [1 week]

   Youth will respond to 25 questions that assess their factual knowledge about clinical research (e.g., Who is part of a clinical trial?). Questions are in multiple choice format and some questions have multiple correct answers. The correct responses were summed across the questions. The range of scores is from 0 to 46. Higher scores indicate more knowledge about clinical research.

2. Attitudes Scores at 1 Week [1 week]

   Youth will be asked to respond to 6 questions that assess their positive attitudes about clinical trials (e.g., How do you feel about kids participating in clinical trials?; 1=Not good at all; 2=Not very good; 3=Not sure; 4=Good; 5=Very good). Responses to this scale were averaged and the minimum scale score was 1 and the maximum scale score was 5. Higher scores indicate more positive attitudes toward clinical trials.

3. Beliefs Scores at 1 Week [1 week]

   Youth will be asked to respond to 5 questions that assess their beliefs about positive aspects of pediatric clinical research (e.g., I believe that clinical trials can help kids; 1=Strongly Disagree; 2=Disagree; 3=Unsure; 4=Agree; 5=Strongly Agree). Responses to this scale were averaged and the minimum scale score was 1 and the maximum scale score was 5. Higher scores indicate more positive beliefs about clinical research.

4. Self-Efficacy to Communicate Scores at 1 Week [1 week]

   Youth will be asked to respond to 10 questions related to their self-efficacy for making decisions related to participation in clinical trials for communicating about clinical trials (e.g., Tell the researcher that I don't want to participate in the clinical trial, even if they really want me to do it; 1 = I cannot do it at all; 5 = I know I can do it.). Responses to this scale were averaged and the minimum scale score was 1 and the maximum scale score was 5. Higher scores indicate more self-efficacy about communicating about clinical trials.

5. Self-Efficacy to Gather Information Scores at 1 Week [1 week]

   Youth will be asked to respond to 9 questions related to their self-efficacy for making decisions related to participation in clinical trials for gathering information about clinical trials (e.g., How sure are you that you can do the following things: Ask my parents questions for more information about clinical trials?; 1 = I cannot do it at all; 5 = I know I can do it.). Responses to this scale were averaged and the minimum scale score was 1 and the maximum scale score was 5. Higher scores indicate more self-efficacy for gathering information about clinical trials.

6. Confidence Scores at 1 Week [1 week]

   Youth will be asked to respond to 3 questions to measure youths' confidence for participating clinical trials (e.g., I know what rights I have in a clinical trial. I know whom to ask if I need more information about a clinical trial.; 1=Strongly Disagree; 2=Disagree; 3=Unsure; 4=Agree; 5=Strongly Agree). Responses to this scale were averaged and the minimum scale score was 1 and the maximum scale score was 5. Higher scores indicate more confidence for participating in clinical trials.

7. Procedural Fears Scores at 1 Week [1 week]

   Youth will be asked to respond to 4 questions related to their perceptions of fear or anxiety about different types of medical procedures, including getting a needle in the arm, injection in the leg, getting a scan, and taking new medicine, on a 5-point Likert scale (1 = Not at all afraid or anxious, 2 = Somewhat afraid or anxious, 3 = Moderately afraid or anxious, 4 = Very afraid or anxious, 5 = Extremely afraid or anxious). Responses to this scale were averaged and the minimum scale score was 1 and the maximum scale score was 5. Higher scores indicate more fears about medical procedures.

8. Likelihood of Participation Scores at 1 Week [1 week]

   Youth will be asked to respond to one question about the likelihood of participating in a clinical trial (i.e., If you were asked to be in a clinical trial, how likely would you be to participate?) using a 5-point Likert scale (1 = Not likely; 5 = Extremely likely). The minimum scale score was 1 and the maximum scale score was 5. Higher scores indicate increased likelihood of participating in a clinical trial.

9. Fear Preventing Participation Scores at 1 Week [1 week]

   Youth will be asked to respond to one question about the likelihood of their fear preventing them from participating in a clinical trial (i.e., How likely is it that your fearful or anxious feelings could stop you from participating in a clinical trial in the future?) using a 5-point Likert scale (1 = Not likely; 5 = Extremely likely). The minimum scale score was 1 and the maximum scale score was 5. Higher scores indicate increased likelihood of fear preventing them from participating in a clinical trial.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Participants must be between the ages of 12 and 17 years.

• Participants must have access to a computer or tablet with Internet connection.

• Participants must be able to read and write in English fluently.

Exclusion Criteria:

• Participants must NOT have previously participated in a clinical trial.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	innovation Research & Training	Durham	North Carolina	United States	27713

Sponsors and Collaborators

• Innovation Research & Training

Investigators

• Principal Investigator: Alison Parker, PhD, Innovation Research & Training

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jun 18, 2020

More Information

Publications

None provided.

• Responsible Party: Alison Parker, Research Scientist, Innovation Research & Training
• ClinicalTrials.gov Identifier: NCT04448210
• Other Study ID Numbers: R44NR019565
• First Posted: Jun 25, 2020
• Last Update Posted: Dec 19, 2020
• Last Verified: Nov 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Chronic Disease; Multiple Chronic Conditions

Study Results

Participant Flow

Arm/Group Title	Educational Website Intervention	Wait-list Control
Arm/Group Description	The intervention is an educational website designed to teach youth (12-17 years) about pediatric clinical trials. DigiKnowIt News: Teen: Teens will interact with a multimedia educational website that will teach them about pediatric clinical trials including topics such as participant rights and safety, benefits and costs to participating in a study, and different types of procedures used in trials.	The wait-list control group did not receive the intervention between the pre-test and post-test assessments. After completing the post-test questionnaire, youth in the wait-list control group had the option to receive access to the intervention (DigiKnowIt News).
Period Title: Overall Study
STARTED	22	20
COMPLETED	22	20
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Educational Website Intervention	Wait-list Control	Total
Arm/Group Description	The intervention is an educational website designed to teach youth (12-17 years) about pediatric clinical trials. DigiKnowIt News: Teen: Teens will interact with a multimedia educational website that will teach them about pediatric clinical trials including topics such as participant rights and safety, benefits and costs to participating in a study, and different types of procedures used in trials.	The wait-list control group did not receive the intervention between the pre-test and post-test assessments. After completing the post-test questionnaire, youth in the wait-list control group had the option to receive access to the intervention (DigiKnowIt News).	Total of all reporting groups
Overall Participants	22	20	42
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	14.14 (1.78)	14.55 (1.64)	14.33 (1.71)
Sex/Gender, Customized (Count of Participants)
Male	12 54.5%	8 40%	20 47.6%
Female	10 45.5%	10 50%	20 47.6%
Non-Binary	0 0%	2 10%	2 4.8%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	5 22.7%	3 15%	8 19%
Not Hispanic or Latino	17 77.3%	17 85%	34 81%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	1 4.5%	0 0%	1 2.4%
Native Hawaiian or Other Pacific Islander	1 4.5%	0 0%	1 2.4%
Black or African American	0 0%	3 15%	3 7.1%
White	18 81.8%	12 60%	30 71.4%
More than one race	2 9.1%	5 25%	7 16.7%
Unknown or Not Reported	0 0%	0 0%	0 0%
Baseline Knowledge Scores (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	35.74 (4.96)	36.25 (4.04)	36.00 (4.47)
Baseline Attitudes Scores (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	3.76 (.75)	3.85 (.65)	3.80 (.70)
Baseline Beliefs Scores (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	4.11 (.64)	4.21 (.51)	4.16 (.58)
Baseline Self-Efficacy for Gathering Information Scores (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	4.23 (.61)	4.21 (.52)	4.22 (.56)
Baseline Self-Efficacy to Communicate Scores (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	4.49 (.61)	4.56 (.54)	4.52 (.57)
Baseline Confidence Scores (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	3.39 (.67)	3.35 (.63)	3.37 (.64)
Baseline Procedural Fears Scores (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	2.28 (.75)	2.46 (.80)	2.37 (.77)
Baseline Likelihood of Participation Scores (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	3.57 (.98)	3.74 (.81)	3.65 (.89)
Baseline Fear Preventing Participation Scores (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	2.29 (.78)	2.35 (1.09)	2.32 (.93)

Outcome Measures

1. Primary Outcome

Title	Knowledge Scores at 1 Week
Description	Youth will respond to 25 questions that assess their factual knowledge about clinical research (e.g., Who is part of a clinical trial?). Questions are in multiple choice format and some questions have multiple correct answers. The correct responses were summed across the questions. The range of scores is from 0 to 46. Higher scores indicate more knowledge about clinical research.
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

In this study, participants were able to skip questions in the questionnaires. Thus, there may not be complete data for all participants for this outcome.

Arm/Group Title	Educational Website Intervention	Wait-list Control
Arm/Group Description	The intervention is an educational website designed to teach youth (12-17 years) about pediatric clinical trials. DigiKnowIt News: Teen: Teens will interact with a multimedia educational website that will teach them about pediatric clinical trials including topics such as participant rights and safety, benefits and costs to participating in a study, and different types of procedures used in trials.	The wait-list control group did not receive the intervention between the pre-test and post-test assessments. After completing the post-test questionnaire, youth in the wait-list control group had the option to receive access to the intervention (DigiKnowIt News).
Measure Participants	19	20
Least Squares Mean (Standard Error) [units on a scale]	35.32 (1.00)	36.93 (.94)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Educational Website Intervention, Wait-list Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<.25
	Comments
	Method	ANOVA
	Comments

2. Primary Outcome

Title	Attitudes Scores at 1 Week
Description	Youth will be asked to respond to 6 questions that assess their positive attitudes about clinical trials (e.g., How do you feel about kids participating in clinical trials?; 1=Not good at all; 2=Not very good; 3=Not sure; 4=Good; 5=Very good). Responses to this scale were averaged and the minimum scale score was 1 and the maximum scale score was 5. Higher scores indicate more positive attitudes toward clinical trials.
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Educational Website Intervention	Wait-list Control
Arm/Group Description	The intervention is an educational website designed to teach youth (12-17 years) about pediatric clinical trials. DigiKnowIt News: Teen: Teens will interact with a multimedia educational website that will teach them about pediatric clinical trials including topics such as participant rights and safety, benefits and costs to participating in a study, and different types of procedures used in trials.	The wait-list control group did not receive the intervention between the pre-test and post-test assessments. After completing the post-test questionnaire, youth in the wait-list control group had the option to receive access to the intervention (DigiKnowIt News).
Measure Participants	22	20
Least Squares Mean (Standard Error) [units on a scale]	3.92 (.09)	3.87 (.09)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Educational Website Intervention, Wait-list Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.72
	Comments
	Method	ANOVA
	Comments

3. Primary Outcome

Title	Beliefs Scores at 1 Week
Description	Youth will be asked to respond to 5 questions that assess their beliefs about positive aspects of pediatric clinical research (e.g., I believe that clinical trials can help kids; 1=Strongly Disagree; 2=Disagree; 3=Unsure; 4=Agree; 5=Strongly Agree). Responses to this scale were averaged and the minimum scale score was 1 and the maximum scale score was 5. Higher scores indicate more positive beliefs about clinical research.
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Educational Website Intervention	Wait-list Control
Arm/Group Description	The intervention is an educational website designed to teach youth (12-17 years) about pediatric clinical trials. DigiKnowIt News: Teen: Teens will interact with a multimedia educational website that will teach them about pediatric clinical trials including topics such as participant rights and safety, benefits and costs to participating in a study, and different types of procedures used in trials.	The wait-list control group did not receive the intervention between the pre-test and post-test assessments. After completing the post-test questionnaire, youth in the wait-list control group had the option to receive access to the intervention (DigiKnowIt News).
Measure Participants	22	20
Least Squares Mean (Standard Error) [units on a scale]	4.40 (.09)	4.23 (.09)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Educational Website Intervention, Wait-list Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.16
	Comments
	Method	ANOVA
	Comments

4. Primary Outcome

Title	Self-Efficacy to Communicate Scores at 1 Week
Description	Youth will be asked to respond to 10 questions related to their self-efficacy for making decisions related to participation in clinical trials for communicating about clinical trials (e.g., Tell the researcher that I don't want to participate in the clinical trial, even if they really want me to do it; 1 = I cannot do it at all; 5 = I know I can do it.). Responses to this scale were averaged and the minimum scale score was 1 and the maximum scale score was 5. Higher scores indicate more self-efficacy about communicating about clinical trials.
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Educational Website Intervention	Wait-list Control
Arm/Group Description	The intervention is an educational website designed to teach youth (12-17 years) about pediatric clinical trials. DigiKnowIt News: Teen: Teens will interact with a multimedia educational website that will teach them about pediatric clinical trials including topics such as participant rights and safety, benefits and costs to participating in a study, and different types of procedures used in trials.	The wait-list control group did not receive the intervention between the pre-test and post-test assessments. After completing the post-test questionnaire, youth in the wait-list control group had the option to receive access to the intervention (DigiKnowIt News).
Measure Participants	22	20
Least Squares Mean (Standard Error) [units on a scale]	4.59 (.10)	4.48 (.10)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Educational Website Intervention, Wait-list Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.43
	Comments
	Method	ANOVA
	Comments

5. Primary Outcome

Title	Self-Efficacy to Gather Information Scores at 1 Week
Description	Youth will be asked to respond to 9 questions related to their self-efficacy for making decisions related to participation in clinical trials for gathering information about clinical trials (e.g., How sure are you that you can do the following things: Ask my parents questions for more information about clinical trials?; 1 = I cannot do it at all; 5 = I know I can do it.). Responses to this scale were averaged and the minimum scale score was 1 and the maximum scale score was 5. Higher scores indicate more self-efficacy for gathering information about clinical trials.
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Educational Website Intervention	Wait-list Control
Arm/Group Description	The intervention is an educational website designed to teach youth (12-17 years) about pediatric clinical trials. DigiKnowIt News: Teen: Teens will interact with a multimedia educational website that will teach them about pediatric clinical trials including topics such as participant rights and safety, benefits and costs to participating in a study, and different types of procedures used in trials.	The wait-list control group did not receive the intervention between the pre-test and post-test assessments. After completing the post-test questionnaire, youth in the wait-list control group had the option to receive access to the intervention (DigiKnowIt News).
Measure Participants	22	20
Least Squares Mean (Standard Error) [units on a scale]	4.33 (.09)	4.38 (.09)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Educational Website Intervention, Wait-list Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.69
	Comments
	Method	ANOVA
	Comments

6. Primary Outcome

Title	Confidence Scores at 1 Week
Description	Youth will be asked to respond to 3 questions to measure youths' confidence for participating clinical trials (e.g., I know what rights I have in a clinical trial. I know whom to ask if I need more information about a clinical trial.; 1=Strongly Disagree; 2=Disagree; 3=Unsure; 4=Agree; 5=Strongly Agree). Responses to this scale were averaged and the minimum scale score was 1 and the maximum scale score was 5. Higher scores indicate more confidence for participating in clinical trials.
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Educational Website Intervention	Wait-list Control
Arm/Group Description	The intervention is an educational website designed to teach youth (12-17 years) about pediatric clinical trials. DigiKnowIt News: Teen: Teens will interact with a multimedia educational website that will teach them about pediatric clinical trials including topics such as participant rights and safety, benefits and costs to participating in a study, and different types of procedures used in trials.	The wait-list control group did not receive the intervention between the pre-test and post-test assessments. After completing the post-test questionnaire, youth in the wait-list control group had the option to receive access to the intervention (DigiKnowIt News).
Measure Participants	22	20
Least Squares Mean (Standard Error) [units on a scale]	3.91 (.14)	3.73 (.14)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Educational Website Intervention, Wait-list Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.38
	Comments
	Method	ANOVA
	Comments

7. Primary Outcome

Title	Procedural Fears Scores at 1 Week
Description	Youth will be asked to respond to 4 questions related to their perceptions of fear or anxiety about different types of medical procedures, including getting a needle in the arm, injection in the leg, getting a scan, and taking new medicine, on a 5-point Likert scale (1 = Not at all afraid or anxious, 2 = Somewhat afraid or anxious, 3 = Moderately afraid or anxious, 4 = Very afraid or anxious, 5 = Extremely afraid or anxious). Responses to this scale were averaged and the minimum scale score was 1 and the maximum scale score was 5. Higher scores indicate more fears about medical procedures.
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Educational Website Intervention	Wait-list Control
Arm/Group Description	The intervention is an educational website designed to teach youth (12-17 years) about pediatric clinical trials. DigiKnowIt News: Teen: Teens will interact with a multimedia educational website that will teach them about pediatric clinical trials including topics such as participant rights and safety, benefits and costs to participating in a study, and different types of procedures used in trials.	The wait-list control group did not receive the intervention between the pre-test and post-test assessments. After completing the post-test questionnaire, youth in the wait-list control group had the option to receive access to the intervention (DigiKnowIt News).
Measure Participants	22	20
Least Squares Mean (Standard Error) [units on a scale]	2.25 (.10)	2.24 (.10)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Educational Website Intervention, Wait-list Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.94
	Comments
	Method	ANOVA
	Comments

8. Primary Outcome

Title	Likelihood of Participation Scores at 1 Week
Description	Youth will be asked to respond to one question about the likelihood of participating in a clinical trial (i.e., If you were asked to be in a clinical trial, how likely would you be to participate?) using a 5-point Likert scale (1 = Not likely; 5 = Extremely likely). The minimum scale score was 1 and the maximum scale score was 5. Higher scores indicate increased likelihood of participating in a clinical trial.
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

In this study, participants were able to skip questions in the questionnaires. Thus, there may not be complete data for all participants for this outcome.

Arm/Group Title	Educational Website Intervention	Wait-list Control
Arm/Group Description	The intervention is an educational website designed to teach youth (12-17 years) about pediatric clinical trials. DigiKnowIt News: Teen: Teens will interact with a multimedia educational website that will teach them about pediatric clinical trials including topics such as participant rights and safety, benefits and costs to participating in a study, and different types of procedures used in trials.	The wait-list control group did not receive the intervention between the pre-test and post-test assessments. After completing the post-test questionnaire, youth in the wait-list control group had the option to receive access to the intervention (DigiKnowIt News).
Measure Participants	21	19
Least Squares Mean (Standard Error) [units on a scale]	3.63 (.15)	3.65 (.15)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Educational Website Intervention, Wait-list Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.94
	Comments
	Method	ANOVA
	Comments

9. Primary Outcome

Title	Fear Preventing Participation Scores at 1 Week
Description	Youth will be asked to respond to one question about the likelihood of their fear preventing them from participating in a clinical trial (i.e., How likely is it that your fearful or anxious feelings could stop you from participating in a clinical trial in the future?) using a 5-point Likert scale (1 = Not likely; 5 = Extremely likely). The minimum scale score was 1 and the maximum scale score was 5. Higher scores indicate increased likelihood of fear preventing them from participating in a clinical trial.
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

In this study, participants were able to skip questions in the questionnaires. Thus, there may not be complete data for all participants for this outcome.

Arm/Group Title	Educational Website Intervention	Wait-list Control
Arm/Group Description	The intervention is an educational website designed to teach youth (12-17 years) about pediatric clinical trials. DigiKnowIt News: Teen: Teens will interact with a multimedia educational website that will teach them about pediatric clinical trials including topics such as participant rights and safety, benefits and costs to participating in a study, and different types of procedures used in trials.	The wait-list control group did not receive the intervention between the pre-test and post-test assessments. After completing the post-test questionnaire, youth in the wait-list control group had the option to receive access to the intervention (DigiKnowIt News).
Measure Participants	21	20
Least Squares Mean (Standard Error) [units on a scale]	2.13 (.18)	2.40 (.18)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Educational Website Intervention, Wait-list Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.30
	Comments
	Method	ANOVA
	Comments

Adverse Events

Time Frame	From baseline to end of intervention at 1 week
Adverse Event Reporting Description	The participants in the study completed web-based questionnaires and utilized an educational website (if in the intervention group). The risks associated with this study were minimal and the participants were not at risk for mortality as a function of participating in this study. Because this study investigated an online behavioral intervention, All-Cause Mortality was not monitored or assessed.
Arm/Group Title	Educational Website Intervention		Wait-list Control
Arm/Group Description	The intervention is an educational website designed to teach youth (12-17 years) about pediatric clinical trials. DigiKnowIt News: Teen: Teens will interact with a multimedia educational website that will teach them about pediatric clinical trials including topics such as participant rights and safety, benefits and costs to participating in a study, and different types of procedures used in trials.		This is a wait-list control group and they did not receive an intervention.
All Cause Mortality
	Educational Website Intervention		Wait-list Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Serious Adverse Events
	Educational Website Intervention		Wait-list Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/22 (0%)		0/20 (0%)
Other (Not Including Serious) Adverse Events
	Educational Website Intervention		Wait-list Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/22 (0%)		0/20 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.