ChildrenNCT02376517
Helping All Children be Safe Outdoors With Sun Protection
A study testing Educational program in people with Children and Parents, run by Northwestern University at 2 sites in United States.
Trial summary
The purpose of this study is to test the effectiveness of a sun protection education program for children of all ethnic and racial backgrounds. Practicing sun protection in childhood can reduce the likelihood of developing skin cancer as an adult. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Children, Parents, Sun Protection
- What is being tested?
- Educational program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2015to Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Are at least 18 years old
- Is the parent of a 2-6 year old child attending a well-child visit
- If the parent present is female, she may be pregnant
- Are able to read in English and/or Spanish at a 6th grade level or higher
- Are able to receive text messages
Who cannot join
- Is the parent of a child less than 2 or older than 6 years old attending a visit
- Unable to read in English and/or Spanish at a 6th grade level or higher
- Unable to receive text messages
- Unable to complete study procedures with eligible child
- Unable to return to clinic for a follow-up visit
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Northwestern University Feinberg School of Medicine Department of Dermatology
Chicago, Illinois, 60611
Advocate Medical Group - Pediatric Clinics
Park Ridge, Illinois, 60068
About this study
The purpose of this study is to test the effectiveness of a sun protection education program for children of all ethnic and racial backgrounds. Practicing sun protection in childhood can reduce the likelihood of developing skin cancer as an adult. The educational program consists of a read-along book in English and Spanish for the child to read with the parent or caregiver, text message reminders to practice sun protection, and a sun protective swim shirt for the child.
Read the detailed description
Melanoma is the third most common form of cancer in adolescents and young adults in the United States. Unprotected sun exposure, particularly during childhood, is an important contributing factor in the risk of developing melanoma later in life. Targeting 2-6 year old children for primary prevention of skin cancer will minimize sun damage and may foster lifelong sun-protective behaviors that will reduce the likelihood of developing skin cancer, especially melanoma. Parental beliefs about and involvement in sun protection are important components of successful skin cancer prevention programs for children, especially young children.
This is a 12-week summer pilot study. The research seeks to develop a multicomponent sun protection program that is feasible for family practice and pediatric clinicians to introduce with anticipatory guidance during well-child visits. The program will further be implemented through a sun protection read-along book in English and Spanish and weekly text message reminders.
The sun protection program will enable behavioral change by caregivers and children of all ethnic and racial backgrounds. Testing the feasibility of delivering the intervention in a family medicine or pediatric practice will allow assessment of accrual and retention rates in a racially/ethnically diverse population, and lead the way to dissemination of good practice.
Participant in this study will be asked to complete two in-person visits at an Advocate Medical Group pediatric clinic. These visits will take place over a four to six week period. The first visit, or Baseline, may be on the same day as the child's well-visit. The second visit, or Follow-Up, will take place at the same location as the Baseline.
Participants randomized to the intervention group will receive the educational program at Baseline, whereas participants in the control group will receive the educational program during Follow-Up.
At the first visit (Baseline), the participant will:
- Complete an anonymous short self-administered questionnaire about knowledge of sun protection and the child's sun protection habits
- Some participants will be asked to complete a survey about cultural affiliation.
- Receive the educational program at the first visit if randomized to the intervention group.
At the second visit (Follow-Up), the participant will:
- Complete an anonymous short self-administered questionnaire about knowledge of sun protection and the child's sun protection habits.
- Receive the educational program at the second visit if randomized to the control group.
At the end of each visit, the amount of melanin (pigment) in the child's skin will be measured. This involves the use of a Mexameter, a device that lightly presses on the child's arm to take a reading (picture) of how much pigment there is in his/her skin. This is neither painful nor invasive.
- Conditions
- Children, Parents, Sun Protection
- Being tested
- Educational program
- Keywords
- Health Behavior, Melanin Index, Spectrophotometry, Sun Protective Clothing, Education, Primary Prevention
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational programBehavioural
The educational program consists of a short (13 pages) read-along book in English and Spanish. This book presents sun protective practices at an appropriate level for 2-6 year old children to read with their parent or caregiver. A sun protective swim shirt, which provides a sun-protection factor (SPF) of over 50, for the child will be provided. Additionally, the parent will receive weekly text message reminders to practice sun protection.
| Study group | Role | What they receive |
|---|---|---|
| Educational program | Active comparator | Participants randomized to the intervention group will receive the educational program at the baseline visit. Receives: Behavioral: Educational program |
| Control | No intervention | Participants randomized to the control group will receive the educational program at the follow-up visit. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Melanin Index at 4-6 weeks
The use of sun protection in those receiving the intervention versus the control group will be examined for correlation with melanin index of child's arm at the baseline and 4-6 week follow-up visit. Spectrophotometer measurement is the wavelength of the reflected light measured in nm. It represents the area under the curve for the all wavelengths of light, thus a reading will be expressed as (192 ±30, mean ± SD).
Measured: Baseline and 4-6 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2015 (estimated)
- Study startMay 2015
- Primary completionAug 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ChildrenStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, June Robinson, Northwestern University
- Investigators
- June K Robinson, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02376517
- Sponsor's protocol ID
- STU00200215
- Status last verified
- Sep 2015
- First submitted
- 20 Feb 2015
- Last updated
- 17 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Ho BK, Reidy K, Huerta I, Dilley K, Crawford S, Hultgren BA, Mallett KA, Turrisi R, Robinson JK. Effectiveness of a Multicomponent Sun Protection Program for Young Children: A Randomized Clinical Trial. JAMA Pediatr. 2016 Apr;170(4):334-42. doi: 10.1001/jamapediatrics.2015.4373.
PubMed 26857829
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Helping All Children be Safe Outdoors With Sun Protection
- ClinicalTrials.gov ID
- NCT02376517
- Acronym / sponsor ID
- STU00200215
- Conditions
- Children, Parents, Sun Protection
- Keywords
- Health Behavior, Melanin Index, Spectrophotometry, Sun Protective Clothing, Education, Primary Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 3 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test the effectiveness of a sun protection education program for children of all ethnic and racial backgrounds. Practicing sun protection in childhood can reduce the likelihood of developing skin cancer as an adult. The educational program consists of a read-along book in English and Spanish for the child to read with the parent or caregiver, text message reminders to practice sun protection, and a sun protective swim shirt for the child.
Detailed description
Melanoma is the third most common form of cancer in adolescents and young adults in the United States. Unprotected sun exposure, particularly during childhood, is an important contributing factor in the risk of developing melanoma later in life. Targeting 2-6 year old children for primary prevention of skin cancer will minimize sun damage and may foster lifelong sun-protective behaviors that will reduce the likelihood of developing skin cancer, especially melanoma. Parental beliefs about and involvement in sun protection are important components of successful skin cancer prevention programs for children, especially young children.
This is a 12-week summer pilot study. The research seeks to develop a multicomponent sun protection program that is feasible for family practice and pediatric clinicians to introduce with anticipatory guidance during well-child visits. The program will further be implemented through a sun protection read-along book in English and Spanish and weekly text message reminders.
The sun protection program will enable behavioral change by caregivers and children of all ethnic and racial backgrounds. Testing the feasibility of delivering the intervention in a family medicine or pediatric practice will allow assessment of accrual and retention rates in a racially/ethnically diverse population, and lead the way to dissemination of good practice.
Participant in this study will be asked to complete two in-person visits at an Advocate Medical Group pediatric clinic. These visits will take place over a four to six week period. The first visit, or Baseline, may be on the same day as the child's well-visit. The second visit, or Follow-Up, will take place at the same location as the Baseline.
Participants randomized to the intervention group will receive the educational program at Baseline, whereas participants in the control group will receive the educational program during Follow-Up.
At the first visit (Baseline), the participant will:
- Complete an anonymous short self-administered questionnaire about knowledge of sun protection and the child's sun protection habits
- Some participants will be asked to complete a survey about cultural affiliation.
- Receive the educational program at the first visit if randomized to the intervention group.
At the second visit (Follow-Up), the participant will:
- Complete an anonymous short self-administered questionnaire about knowledge of sun protection and the child's sun protection habits.
- Receive the educational program at the second visit if randomized to the control group.
At the end of each visit, the amount of melanin (pigment) in the child's skin will be measured. This involves the use of a Mexameter, a device that lightly presses on the child's arm to take a reading (picture) of how much pigment there is in his/her skin. This is neither painful nor invasive.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Educational program | Active comparator | Behavioral: Educational programParticipants randomized to the intervention group will receive the educational program at the baseline visit. |
| Control | No intervention | –Participants randomized to the control group will receive the educational program at the follow-up visit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Are at least 18 years old
- Is the parent of a 2-6 year old child attending a well-child visit
- If the parent present is female, she may be pregnant
- Are able to read in English and/or Spanish at a 6th grade level or higher
- Are able to receive text messages
Key exclusion criteria (5 listed)
- Is the parent of a child less than 2 or older than 6 years old attending a visit
- Unable to read in English and/or Spanish at a 6th grade level or higher
- Unable to receive text messages
- Unable to complete study procedures with eligible child
- Unable to return to clinic for a follow-up visit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational programThe educational program consists of a short (13 pages) read-along book in English and Spanish. This book presents sun protective practices at an appropriate level for 2-6 year old children to read with their parent or caregiver. A sun protective swim shirt, which provides a sun-protection factor (SPF) of over 50, for the child will be provided. Additionally, the parent will receive weekly text message reminders to practice sun protection. | Behavioural | Educational program |
Primary outcome
Change from Baseline Melanin Index at 4-6 weeks
Time frame: Baseline and 4-6 Weeks
The use of sun protection in those receiving the intervention versus the control group will be examined for correlation with melanin index of child's arm at the baseline and 4-6 week follow-up visit. Spectrophotometer measurement is the wavelength of the reflected light measured in nm. It represents the area under the curve for the all wavelengths of light, thus a reading will be expressed as (192 ±30, mean ± SD).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2015.
- Derived from this study: PubMed 26857829Ho BK, Reidy K, Huerta I, Dilley K, Crawford S, Hultgren BA, Mallett KA, Turrisi R, Robinson JK. Effectiveness of a Multicomponent Sun Protection Program for Young Children: A Randomized Clinical Trial. JAMA Pediatr. 2016 Apr;170(4):334-42. doi: 10.1001/jamapediatrics.2015.4373.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
June K Robinson, MD principal investigator
Northwestern University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational program in people with Children and Parents, run by Northwestern University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Melanin Index at 4-6 weeks (time frame: Baseline and 4-6 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02376517, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2015.