A research team led by Dr. Yelena Wu from the University of Utah and the Huntsman Cancer Institute, and including Dr. David Buller from Klein Buendel, has published a detailed protocol for the project entitled, “Sun-safe Habits Intervention and Education” in Contemporary Clinical Trials. Project SHINE examines the efficacy of a personalized intervention targeting sun protection and tanning of high school students.
Adolescents infrequently use sun protection and engage in intentional tanning more frequently compared to other age groups, leading to increased ultraviolet radiation (UVR) exposure that heightens skin cancer risk across the lifespan. High schools are therefore an ideal setting for offering skin cancer prevention interventions. Yet, there are limited UVR protection interventions for high school students, especially those that are personalized, tested using randomized designs, and include long-term outcome assessment to determine the durability of intervention effects.
The SHINE cluster-randomized trial will test a novel, personalized intervention that targets high school adolescents’ sun protection and tanning behaviors, and tracks their outcomes for up to one year following intervention. Enrolled high schools will be randomized to receive either the personalized SHINE intervention, which includes facial UVR photographs and sun protection action planning, or standard education using publicly available materials. Students in both conditions will receive information about skin cancer, sun protection, and skin self-examination. Outcome variables will include students’ sun protection and tanning behaviors and sunburn occurrence. Potential moderators (such as race/ethnicity) and mediators (such as self-efficacy) will also be assessed and tested.
The investigators believe Project SHINE will lead to new scientific understanding of the theoretical mechanisms underlying outcomes and moderators of the intervention effects, which will inform future intervention tailoring to meet the needs of vulnerable subgroups.
This research is sponsored by the National Cancer Institute (Dr. Yelena Wu from the University of Utah and the Huntsman Cancer Institute, Principal Investigator). Dr. David Buller, Director of Research at Klein Buendel, is a Co-Investigator.
Klein Buendel has partnered with HPC International, a leading purchased services provider for healthcare, corporations and academic institutions, to create Pinpoint™, the first-of-its-kind sickle cell pain management app, which provides a safe, interactive, and convenient way for patients to learn about, track, assess, and communicate with their doctors about their sickle cell pain.
The Pinpoint sickle cell pain management app provides a safe, interactive, and convenient way for patients to learn about, track, assess, and communicate with their doctors about sickle cell pain.
Developed with teens in mind, people of all ages benefit from the Pinpoint app to identify different types of pain associated with sickle cell disease. Using gaming technology, Pinpoint offers an innovative pain assessment tool and a pain diary to log physical and emotional pain symptoms. With the touch of a finger, patients are able to describe and assess the intensity, duration, quality, nature, and location of the pain and report it to their caregivers and physician in real-time. Pinpoint is a web app and works on any smartphone or smart mobile device. Patients can play games, watch videos, learn preventive health tips, and visit the Patient Stories section with real stories and inspirational messages told by other sickle cell patients.
Sickle cell disease is an inherited disorder of the red blood cells that disproportionately affects people of color. Chronic pain is the most common complication and profoundly disrupts people’s quality of life. Clinicians are often unsuccessful at addressing chronic pain in sickle cell disease, underscoring the need for the Pinpoint app.
“The pain caused by sickle cell disease is incredibly difficult to manage and ‘pinpoint,’ especially for young patients,” said Hilton Hudson, MD, FACS, CEO of HPC International. “When meeting with top researchers at Children’s Hospital in Washington D.C., we all agreed that clinicians needed a better way to treat the different types of pain sickle cell patients may experience, which led HPC to develop a tool to do just that.”
“Teaming up with HPC International and supported by grants from the NIH, Klein Buendel was privileged to create a supportive pain management tool for patients with sickle cell disease,” said Mary Buller, MA, President of Klein Buendel. “HPC and Klein Buendel combined content experts and web developers into a winning combination for patients and doctors.”
The educational content in the Pinpoint app comes from the renowned and best-selling Hope & Destiny book series, written by three clinical expert leaders in hematology: James Eckman, MD, Lewis L Hsu, MD, PhD and Allan Platt, PA-C, MMSc. Hope & Destiny is Hilton Publishing’s premier educational book series on sickle cell disease and is tailored for different reader age groups, including adults and parents as well as adolescent patients.
The Pinpoint app development project was facilitated through two Small Business Innovative Research (SBIR) grants, awarded in 2016 and 2018 by the National Institutes of Health (NIH). HPC collaborated with Klein Buendel, medical experts, teens, and parents of children with sickle cell disease to study how an interactive app with a customized pain assessment tool could provide an improved way for adolescents with sickle cell disease to learn about and better manage their disorder. The study’s Expert Advisory Board was formed by clinicians from institutions and nonprofit organizations including HOPE for SCD, UIC, Emory Healthcare, Children’s National, Marquette University College of Nursing, and the International Association of Sickle Cell Nurses and Professional Associates.
Pinpoint has been clinically evaluated to help aid in the management of pain caused by sickle cell disease. Market research, focus groups, surveys, interviews, and two comprehensive research studies were conducted virtually and in-person with teens, parents and clinical specialists representing communities across the country from 2016 through 2022. Research reported in this press release was supported by the National Institute on Minority Health and Health Disparities under grant numbers R43MD010746 and R44MD010746 awarded to Klein Buendel (Dr. Valerie Myers, initial Principal Investigator; Ms. Julia Berteletti, final Principal Investigator). Pinpoint was designed and programmed by Mr. Adam Ashby of the Klein Buendel Creative Team.
Already, Pinpoint has been featured in:
Sickle Cell Disease News, a healthcare industry website, which provides the sickle cell disease community with the most recent news and information on sickle cell disease.
MedCity News, a leading digital healthcare outlet.
LegalReader.com in their Health & Medicine section on August 23rd.
Healthcare IT Today, a leading digital health tech outlet, in a roundup of healthcare industry news (under the ‘Partnerships’ section) on August 17th.
Pinpoint is available to individuals and medical providers. An individual annual subscription fee is $9.99. To learn more about the Pinpoint app, check out the video tutorial or visit HPC International.
Wendy Hadley, PhD, is an Associate Professor in the Department of Counseling Psychology and Human Services in the College of Education at the University of Oregon. She is also the Julie and Keith Thomson Faculty Chair and HEDCO Clinic Director at the University of Oregon.
Dr. Wendy Hadley
Dr. Hadley received her doctoral degree in clinical child psychology and behavioral medicine from the University of Memphis in 2003. She went on to complete a postdoctoral fellowship with the Brown University Clinical Consortium. Dr. Hadley has worked with many pediatric patients and their families, including those affected by cancer, HIV, feeding disorders, cardiac issues, and obesity.
In addition to her clinical work, Dr Hadley conducts research on adolescent health issues such as obesity, substance use, and risky sexual behaviors. Her recent work has focused on the development and evaluation of interventions focusing on parent-child communication, parental monitoring, and adolescent emotion regulation skills. Some of her work uses web-based technology to deliver and enhance the interventions.
Dr. Hadley is currently working as a Co-Investigator on a collaborative web-based project with Dr. Christopher Houck (Principal Investigator) from Rhode Island Hospital and its parent organization Lifespan Health Systems. The program is called iTRAC, which stands for “Talking about Risk and Adolescent Choices.” The research is funded by an STTR Fast-Track grant to Klein Buendel from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (Dr. Christopher Houck, Principal Investigator; HD110333). The goal of the project is to convert the previously existing TRAC program to a web app format while integrating emotional regulation and sexual health education. The program targets young adolescents (ages 12-14 years) at a crucial time of development in order to provide them with evidence-based approaches to manage emotional situations and risky behavior. Additional Co-Investigators include Dr. David Barker from Rhode Island Hospital and Ms. Julia Berteletti from Klein Buendel.
Klein Buendel collaborator, Dr. Aida Midgett from Boise State University, presented formative research findings from her CTR-IN Pilot Grant at the Mountain West CTR-IN Annual Meeting in Las Vegas, Nevada, November 17-18, 2022. Mountain West CTR-IN connects research investigators to mentors, collaborators, and funding opportunities to improve the health and lives of people in mountain west communities, including through research projects funded by the National Institutes of Health. Ms. Mary Buller, President of Klein Buendel, is Dr. Aida’s mentor for the CTR-IN Pilot Grant.
Dr. Midgett presented on the “Development, Acceptability, and Short-Term Outcomes of a Parent Module for Brief, Bullying Bystander Intervention for Middle School Students in Rural, Low-Income Communities.” Her co-author was Dr. Diana Doumas from Boise State University. The project statistician was Ms. Laura Bond from Boise State University. The pilot study used a mixed-methods design to develop a 30-minute pre-recorded Parent Module as a companion training to a brief bullying prevention program for middle schools, called STAC. The study assessed the need, feasibility, acceptability, delivery format preference and immediate outcomes (e.g., knowledge, attitudes, self-efficacy, and behavioral intentions) of the Parent Module.
As background, the STAC bystander intervention is a 75-minute training that includes didactic and experiential components. It teaches middle school students to act as “defenders” on behalf of targets of bullying through utilizing four intervention strategies: (1) “Stealing the Show” – using humor or distraction to interrupt a bullying situation and remove the attention away from the target; (2) “Turning it Over” – identifying a trusted adult at school, reporting, and asking for help during a bullying incident; (3) “Accompanying Others” – befriending and/or providing support to a peer who was a target of bullying; and (4) “Coaching Compassion” – gently confronting the perpetrator and increasing empathy for the target.
Dr. Midgett reported that preliminary data with 23 parents in the pilot study demonstrated acceptability, relevance, and need and increases in immediate post-training outcomes including knowledge, confidence, self-efficacy, responsibility, and anti-bullying attitudes, as well as parents’ behavioral intentions to support their adolescents to utilize the STAC strategies.
Another aim of Dr. Midgett’s CTR-IN pilot grant is to provide data to support a STTR Fast Track proposal to develop and evaluate a web-based version of the Parent Module as a STAC companion training. The proposal will be submitted through Klein Buendel and the research plan will include a multi-site randomized trial in rural schools. Klein Buendel’s Creative Team will program the web-based Parent Module.
A research team led by Dr. Christopher Houck from Lifespan and the Rhode Island Hospital has published a paper in the Journal of Developmental & Behavioral Pediatrics on the feasibility and acceptability of an initial digital iTRAC (Talking About Risk and Adolescent Choices) intervention. Collaborators included colleagues from the Rhode Island Hospital, the University of Oregon, Brown University, Penn State University, and Klein Buendel. iTRAC is a tablet-based intervention to promote emotion regulation skills among middle schoolers as a strategy for reducing risky behavior.
For the pilot study, adolescents aged 12–14 years were recruited from three urban schools for advisory groups (n=15), acceptability testing (n=11), and pilot testing (n=85). Youth advisory boards and expert panels tailored content, resulting in an animated intervention of instructional videos, games, and activities designed to teach emotion regulation strategies to young adolescents. Eighty-five adolescents were randomized to the 4-module digital iTRAC intervention or a wait-list control group. Adolescents and one parent completed baseline and 3-month follow-up questionnaires examining emotion regulation attitudes and behaviors. The adolescent participants also completed behavioral tasks related to distress tolerance.
Eighty-eight percent of those randomized to iTRAC completed all modules. Moderate effect sizes were found from baseline to follow-up on adolescents’ beliefs in the controllability of emotions, awareness of emotions, self-efficacy for managing emotions, perceived access to emotion regulation strategies, and use of emotion regulation strategies. Parent measures of adolescent regulation showed mixed results.
A tablet-based intervention to enhance emotion skills for youth in early adolescence was deemed feasible and demonstrated promising indicators of impact on emotional competence. Increasing adolescents’ awareness of and access to emotion regulation strategies may reduce decisions driven by transient emotions, which in turn may reduce engagement in risky behavior and resultant negative health outcomes. The authors conclude that the brief iTRAC intervention may be used to increase emotional competency among middle schoolers.
Dr. Valerie Myers and Ms. Tiffany Jerrod, both formerly from Klein Buendel, were co-authors on this publication. Research on the full production and evaluation of iTRAC is continuing with an STTR Fast Track grant to Klein Buendel from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (Dr. Christopher Houck, Principal Investigator from Lifespan; HD110333). Collaborators on the current study include Dr. Wendy Hadley from the University of Oregon; Dr. David Barker from Rhode Island Hospital; and Ms. Julia Berteletti from Klein Buendel. The iTRAC modules will be programmed by Klein Buendel’s Creative Team.
A collaborative research team from the University of Oregon, Rhode Island Hospital and its parent organization Lifespan Health Systems, and Klein Buendel has launched a new research project to develop and evaluate the impact of an emotion regulation program for adolescents. iTRAC will be a web-based program for “Talking about Risk and Adolescent Choices” to prevent risky sexual behavior and negative sexual health outcomes through emotion regulation strategies. The original TRAC program was developed and evaluated in multiple previous studies (MH078750, NR011906, and HD089979) by Dr. Christopher Houck from Lifespan and his team.
In the new study, the original TRAC will be enhanced for emotion regulation, programmed as a web-based app (iTRAC) and assessed for acceptability by adolescents ages 12 to 14. The investigators will then conduct a randomized controlled trial examining the efficacy of the completed iTRAC intervention relative to a waitlist control among 120 adolescents. The study will examine the efficacy of iTRAC relative to a waitlist control in enhancing theoretically important emotional competencies, such as emotion regulation, emotion recognition, and distress tolerance that mediate risk as measured by self-report, performance measures, and parent report.
The investigators hypothesize that: (1) iTRAC will receive positive adolescent ratings during acceptability testing for ease of use, enjoyment, and usefulness of content; (2) participants in iTRAC will report greater self-efficacy for sexual risk prevention skills over 6-month follow-up than comparison participants; and (3) youth in iTRAC will exhibit improved emotional competencies relative to the comparison group.
The iTRAC project is funded by an STTR Fast Track grant to Klein Buendel from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (Dr. Christopher Houck, Principal Investigator from Lifespan; HD110333). Collaborators include Dr. Wendy Hadley from the University of Oregon; Dr. David Barker from Rhode Island Hospital; and Ms. Julia Berteletti from Klein Buendel. The iTRAC modules will be programmed by Klein Buendel’s Creative Team.
Susan Breitenstein, PhD, RN, FNAP, FAAN, is an Associate Professor, Assistant Dean for Research and Innovation, and Senior Director of the Community Outreach and Engagement & CHW Training Program at The Ohio State University College of Nursing. She received her PhD from Rush University. Her clinical training is as a child and adolescent psychiatric nurse. Working clinically with children, adolescents, and families with mental health issues led Dr. Breitenstein to focus her research efforts on mental health promotion and prevention through implementation and dissemination of evidence-based parenting interventions. Her other research interests include fatherhood interventions and intervention fidelity. In addition to research, Dr. Breitenstein serves as Secretary of the Global Implementation Society.
Currently, Dr. Breitenstein is collaborating with Ms. Julia Berteletti from Klein Buendel on a research study entitled, “Parent Training for Parents of Toddlers Born Very Premature: A Factorial Design to Test Web Delivery and Telephone Coaching” (HD104072; Dr. Breitenstein, Principal Investigator). This study is an adaptation of the Chicago Parent Program and will focus on parenting children who were born very premature, or before 32 weeks gestational age. The Chicago Parent Program is a 12-session parenting program designed to reduce behavioral issues in young children, ages 2-5 years, through strengthening parenting skills. Children who are born very premature have higher risks and vulnerabilities for developing behavioral problems. This study aims to test digital delivery of parent training plus coaching calls for parents of toddlers who were born very premature.
Yelena Wu, PhD, is an Associate Professor in the Department of Dermatology at the University of Utah and a Research Investigator at the Huntsman Cancer Institute. She received a BA in Psychology from the University of California, Berkeley, and an MA and PhD in Clinical Child Psychology from the University of Kansas. She is also a licensed pediatric and clinical child psychologist.
Dr. Wu’s research and clinical practice center on promoting better health outcomes for children, adolescents, and young adults who have a history of cancer or who are at risk for developing cancer. A specific area of research interest is the prevention of skin cancer by improving adherence to preventive behavior recommendations among children and adolescents at increased risk for developing skin cancer.
Dr. Wu is currently the Principal Investigator on a 5-year project funded by National Cancer Institute (CA244674) to test a school-based program designed to increase adolescents’ use of sun protection and decrease participation in intentional tanning. Dr. David Buller, director of Research at Klein Buendel, collaborates as a Co-Investigator on the project.
In addition to her research, Dr. Wu provides consultations and therapeutic services to medical teams, patients, and caregivers to facilitate communication and aid in the management of cancer through the Family Cancer Assessment Clinic at the Huntsman Cancer Institute.
Healthy decision-making by older adolescents and young adults can be fostered by active parental relationships and mutual engagement.
Two Klein Buendel Scientists are co-authors on a paper in the journal JMIR Pediatrics and Parentinglooking at healthy decision-making. Dr. Gill Woodall and Dr. David Buller are members of a research team led by Dr. Brenda Miller from the Pacific Institute for Research and Evaluation (PIRE). The paper, whose lead author is Dr. Beth Bourdeau from the University of California, San Francisco, reports findings from a study designed to test the efficacy of the Healthy Relationships and Sexual Decision-making component of a web-based intervention for older adolescents and their parents, called Smart Choices 4 Teens.
The paper describes the details of the final segment of a randomized controlled trial conducted with 411 families with adolescents aged 16-17 years. Adolescents and parents worked through the web-based, self-paced program together. “Participation in the relationships component increased the frequency of parental sexual communication and increased the number of dating rules after accounting for other significant adolescent characteristics.” The paper reports that “Smart Choices 4 Teens demonstrated efficacy in increasing the frequency of sexual communication between parents and adolescents in the long term.”
The Smart Choices 4 Teens research was supported by a grant from the National Institute on Alcohol Abuse and Alcoholism (AA020977; Dr. Brenda Miller, PIRE, Principal Investigator). Other authors on this publication include Dr. Hilary Byrnes and Dr. Joel Grube from PIRE; Dr. Beth Bourdeau from the University of California San Francisco; and Dr. Gill Woodall and Dr. David Buller from Klein Buendel. Smart Choices 4 Teens was programmed by the Creative Team at Klein Buendel.
A Tablet-delivered Intervention to Reduce Risky Behavior in Adolescents
Klein Buendel collaborator, Dr. Christopher Houck from Rhode Island Hospital, will present findings from Project TRAC at the Society of Research on Adolescence Biennial Meeting in San Diego, California, March 19-21, 2020. His presentation will also include a demonstration of the targeted games used in the intervention.
The team
initially developed and validated an Emotion Regulation (ER) intervention for
reducing risk behaviors among early adolescents. Project TRAC showed that
adolescents who learned about sexual health information with ER content were
significantly less likely to transition to sexual activity. Despite the promise
of targeting ER during early adolescence to prevent risk behaviors, discussions
with community partners suggest that the original facilitator-led small-group
format is difficult to sustain. Disseminating this prevention approach required
a format that was less reliant on specialized training that could be easily
implemented to an individual format. Therefore, through advisory panels of
early adolescents and consultation from a group of experts in the field,
Project TRAC was translated from a small-group format to a tablet-delivered,
game-based program.
Acceptability
testing took place with ten adolescents followed by 85 adolescents who participated
in a small randomized pilot trial to assess the feasibility of the digital
intervention as well as preliminary assessment of short-term changes in ER. Those
randomized to the intervention condition completed four computerized modules
that taught emotion concepts through games and instructional videos. Control
participants were waitlisted to complete the intervention at the end of the
study and all adolescents completed surveys at baseline and one month later.
Participants positively
rated the intervention with a majority completing all four modules. Intervention
participants self-reported significant improvements, including emotional
awareness, perceived access to ER strategies, use of the strategies taught in
the intervention, intentions to use these strategies, emotional knowledge, and
perceptions that emotions are changeable. They also reported a moderate effect
of poorer perceptions of abilities to manage positive emotions.
Results suggest that a tablet-based intervention providing ER
training was able to affect adolescents’ use of ER behaviors, understanding of
emotions, and perceptions of emotional competence. Linking ER training to
specific areas of risk (sexual health, substance use, or violence prevention)
in the developmental window when risk behaviors are beginning, such as early
adolescence, may prevent risk behaviors for many young people. Dissemination of
evidence-based interventions through tablet formats may also improve the reach
of effective interventions.
This research is funded by a grant from the National Institute of
Child Health and Human Development (HD089979; Dr. Christopher Houck, Principal
Investigator). Other collaborators include Wendy Hadley from the University of
Oregon; Crosby Modrowski and Kelsey Bala from Brown University; Brittany Wickham
from Villanova University; and Dr. Valerie Myers and Tiffany Jerrod from Klein
Buendel.
