Shifting perspectives and transformative change: Parent perspectives of an active music engagement intervention for themselves and their child with cancer.

BACKGROUND: Children with cancer (ages 3-8 years) and their parents experience significant, interrelated distress associated with cancer treatment. Active music engagement (AME) uses music-based play and shared music-making to mitigate this distress. To advance our understanding about how AME works and its essential features, we interviewed parents who received the AME intervention as part of a multi-site mechanistic trial. The purpose of this qualitative analysis was to describe parents' experiences of AME for themselves and their child and to better understand how the intervention worked to lower parent-child distress. PROCEDURE: We conducted a total of 43 interviews with parents/caregivers, and purposively analyzed all interviews from underrepresented groups based on race/ethnicity and parent role. We used thematic analysis and achieved thematic redundancy after analyzing 28 interviews. RESULTS: The following statement summarizes resulting themes: Music therapists skillfully use AME to create a safe and healthy space (Theme 1), where parents/children have transformative experiences (Theme 2) that lead to learning and enactment (Theme 3) of new skills that counteract suffering (Theme 4) through empowerment, connectedness, and sustained relief. CONCLUSIONS: This work elucidates how AME works to counteract stressful qualities of cancer treatment. As parents witnessed positive and transformative changes in their child, they experienced relief and reported shifts in their perspective about cancer treatment. This led to learning and use of music as a coping strategy that extended beyond therapist-led sessions. Accessible, music-based interventions, like AME, offer a developmentally appropriate and effective way to support parents and young children during treatment.

Rapid implementation of Veterans Health Administration telehealth creative arts therapies: survey evaluation of adoption and adaptation.

BACKGROUND: Creative arts therapies (CAT) are employed throughout the Veterans Health Administration (VHA) and are predominantly delivered in-person. Though telehealth delivery of CAT was used at several VHA facilities to increase services to rural Veterans, due to guidance from the Center for Disease Control and VHA that temporarily suspended or reduced in-person services, there was a large increase of CAT therapists enterprise-wide who adopted telehealth delivery. The aims of this study were to evaluate adoption and adaptation of CAT telehealth delivery and identify related barriers and facilitators. METHODS: We deployed a survey guided by the Consolidated Framework for Implementation Research and administered it via email to all VHA CAT therapists (N = 120). Descriptive statistics were used to summarize data and responses were compared based on therapists' age, years of experience and CAT discipline. Open survey field responses were summarized, qualitatively coded, and analyzed thematically. RESULTS: Most therapists (76%) reported adopting telehealth with 74% each delivering > 50 CAT sessions in the prior year. Therapists adapted interventions or created new ones to be delivered through telehealth. Barriers included: technical challenges, control of the virtual space, and building rapport. Facilitators included added equipment, software, and infrastructure. CAT therapists adapted their session preparation, session content, outcome expectations, and equipment. CAT therapists reported being able to reach more patients and improved access to care with telehealth compared to in person visits. Additional benefits were patient therapeutic effects from attending sessions from home, therapist convenience, and clinician growth. CONCLUSIONS: VHA CAT therapists used their inherent creativity to problem solve difficulties and make adaptations for CAT telehealth adoption. Future studies may explore CAT telehealth sustainment and its effectiveness on clinical processes and outcomes.

Veterans Hospital Administration Telehealth Utilization for Recreation and Creative Arts Therapies: A Brief Report.

Background: A brief query was fielded to Veterans Health Administration (VHA) facilities across the United States to provide an initial assessment of recreation therapy (RT) and creative arts therapy (CAT) telehealth utilization. Methods: To develop an understanding of barriers and identify potential solutions for better delivery of services, a cross-sectional survey was deployed to points of contact at 136 VHA facilities. The survey included questions across five areas: staff, infrastructure, barriers to use, training, and interventions being deployed. Descriptive statistics were calculated, and a thematic analysis of qualitative responses was conducted. Results: The most frequent themes from aggregated responses indicated a need for hands-on training, reliable telehealth equipment, and accessible training and tools for Veteran patients who want to use telehealth services. Conclusion: Telehealth delivery of RT/CAT has increased services to Veteran patient populations; however, equipment and training are needed to expand consistent delivery to enhance patient reach across a national health care system.

Pilot Randomized Trial of Active Music Engagement Intervention Parent Delivery for Young Children With Cancer.

Objectives: To examine the feasibility/acceptability of a parent-delivered Active Music Engagement (AME + P) intervention for young children with cancer and their parents. Secondary aim to explore changes in AME + P child emotional distress (facial affect) and parent emotional distress (mood; traumatic stress symptoms) relative to controls. Methods: A pilot two-group randomized trial was conducted with parents/children (ages 3-8 years) receiving AME + P ( n = 9) or attention control ( n = 7). Feasibility of parent delivery was assessed using a delivery checklist and child engagement; acceptability through parent interviews; preliminary outcomes at baseline, postintervention, 30 days postintervention. Results: Parent delivery was feasible, as they successfully delivered AME activities, but interviews indicated parent delivery was not acceptable to parents. Emotional distress was lower for AME + P children, but parents derived no benefit. Conclusions: Despite child benefit, findings do not support parent delivery of AME + P.

Developing a Multiple Caregiver Group for Caregivers of Adolescents With Disruptive Behaviors.

This article describes the development of a 6-week multiple caregiver group intervention for primary caregivers of adolescents diagnosed with Oppositional Defiant Disorder or Conduct Disorder in low-income African American families. The intervention is aimed at increasing the primary caregivers' self-efficacy in managing interactions within the family and especially with child serving educational, mental health, juvenile justice, and child welfare systems. Development of the intervention involved seven iterative activities performed in a collaborative effort between an interdisciplinary academic team, community engagement specialists, members of the targeted population, and clinical partners from a large public mental health system. The intervention development process described in this article can provide guidance for teams that aim to develop new mental health interventions that target specific outcomes in populations with unique needs.

Life goals in patients with cancer: a systematic review of the literature.

OBJECTIVE: Purposes of this systematic review of life goal research in cancer patients were to (1) identify life goal characteristics and processes being examined, (2) describe instruments used to assess life goal constructs, (3) identify theoretical models being used to guide research, and (4) summarize what is known about the impact of the cancer experience on life goal characteristics, processes, and psychological outcomes. METHODS: We conducted this systematic review using MEDLINE, PubMed, CINAHL, and PsycINFO databases. Inclusion criteria were as follows: (1) published between 1993 and 2014, (2) English language, (3) cancer patient population, and (4) original research articles that assessed life goal characteristics and/or goal processes. One hundred ninety-seven articles were screened and 27 included in the final review. RESULTS: Seven life goal characteristics and seven life goal processes were identified, and less than half of studies investigated associations between goal characteristics and processes. Conceptual definitions were not provided for about half of the identified life goal constructs. Studies used both validated and author-developed instruments to assess goal constructs. Twenty-four different theoretical models were identified, with self-regulation theory most frequently cited. Overall, the literature suggests that cancer impacts patients' life goal characteristics and processes, and life goal disturbance is related to poorer psychological outcomes. CONCLUSIONS: The impact of the cancer experience on life goals is an important and emerging area of research that would benefit from conceptual and theoretical clarity and measurement consistency.

Randomized clinical trial of therapeutic music video intervention for resilience outcomes in adolescents/young adults undergoing hematopoietic stem cell transplant: a report from the Children's Oncology Group.

BACKGROUND: To reduce the risk of adjustment problems associated with hematopoietic stem cell transplant (HSCT) for adolescents/young adults (AYAs), we examined efficacy of a therapeutic music video (TMV) intervention delivered during the acute phase of HSCT to: 1) increase protective factors of spiritual perspective, social integration, family environment, courageous coping, and hope-derived meaning; 2) decrease risk factors of illness-related distress and defensive coping; and 3) increase outcomes of self-transcendence and resilience. METHODS: This was a multisite randomized, controlled trial (COG-ANUR0631) conducted at 8 Children's Oncology Group sites involving 113 AYAs aged 11-24 years undergoing myeloablative HSCT. Participants, randomized to the TMV or low-dose control (audiobooks) group, completed 6 sessions over 3 weeks with a board-certified music therapist. Variables were based on Haase's Resilience in Illness Model (RIM). Participants completed measures related to latent variables of illness-related distress, social integration, spiritual perspective, family environment, coping, hope-derived meaning, and resilience at baseline (T1), postintervention (T2), and 100 days posttransplant (T3). RESULTS: At T2, the TMV group reported significantly better courageous coping (Effect Size [ES], 0.505; P = .030). At T3, the TMV group reported significantly better social integration (ES, 0.543; P = .028) and family environment (ES, 0.663; P = .008), as well as moderate nonsignificant effect sizes for spiritual perspective (ES, 0.450; P = .071) and self-transcendence (ES, 0.424; P = .088). CONCLUSIONS: The TMV intervention improves positive health outcomes of courageous coping, social integration, and family environment during a high-risk cancer treatment. We recommend the TMV be examined in a broader population of AYAs with high-risk cancers.

Perceptions of communication, family adaptability and cohesion: a comparison of adolescents newly diagnosed with cancer and their parents.

PURPOSE: To describe and compare adolescent and parent perspectives on communication, family adaptability and cohesion, as well as relationships among these variables, during the first month of an adolescent's cancer diagnosis. METHODS: Seventy adolescent-parent dyads were enrolled as part of a larger multi-site study. The adolescents ranged in age from 11 to 19, and 61% were males. Parents were predominately mothers (83%). Dyads were predominately non-Hispanic Caucasian (63%). Measures included the Parent-Adolescent Communication Scale and the Family Adaptability and Cohesion Evaluation Scale (FACES II). Paired t-tests, Pearson correlations, intra-class correlation coefficients and multiple linear regression analyses were completed. RESULTS: Adolescent scores on communication, family adaptability and cohesion were significantly lower than parent scores. The inter-dyadic agreement between adolescents and parents was low. Communication, family adaptability and cohesion were examined separately for adolescents and for parents, and significant relationships were found. Both adolescent- and parent-perceived communication was significantly associated with family adaptability and cohesion outcomes. CONCLUSIONS: Differences were found in adolescent and parent perceptions of communication, family adaptability and cohesion. When both adolescents and parents had better perceived communication, this was associated with better perceived family adaptability and cohesion. Results suggest that the development of interventions to enhance adolescent-parent communication could help foster better family adaptability and cohesion, which may ultimately impact their psychological adjustment. In addition, understanding the degree to which adolescents and parents disagree on their perceptions, including the results that parents generally have more favorable perceptions, may be a useful starting point when developing interventions.

Spirituality in Adolescents and Young Adults With Cancer: An Evolutionary Concept Analysis.

Background: Despite an increased focus on the importance of spirituality to human health, including adolescent health outcomes there remains an absence of evidence-based programs to address the spiritual needs of patients and families. A critical barrier is the absence of a clear conceptual understanding and operational definitions of spirituality for adolescents/young adults (AYAs) with cancer. The purposes of this concept analysis were to (a) clarify the concept of spirituality in the context of the AYAs' cancer experience and (b) generate a definition based on a review of the literature examining spiritual development and the role of spirituality in AYAs' health and cancer treatment. Method: We used Roger's evolutionary concept analysis method to identify antecedents, attributes, and consequences of spirituality in the context of AYAs' cancer using thematic analysis and included identification of case exemplars. Results: Of the 86 articles identified, 21 met our inclusion criteria. Analysis revealed four attributes of spirituality in AYAs with cancer: meaning and purpose, connectedness, life-long universal experience, and independent of or related to religion and faith traditions. Identified antecedents included the presence of spiritual resources, chronic illness, belief, or wonder about a higher power, and existential questions. Identified consequences included hope, meaning, feelings of peace, and enhanced well-being and illness acceptance. Based on the findings, we generated a definition of spirituality in AYAs with cancer. Discussion: Findings inform the development of measures and spiritual care interventions specific to AYAs with cancer. An important limitation to address in future research is the absence of AYAs' first-person accounts of their own spirituality.

Telehealth Engaged Music for Pain Outcomes: A Music and Imagery Proof-of-concept Study with Veterans.

Music therapy interventions target biopsychosocial outcomes and are a non-pharmacological option for integrated pain management. To date, most music and pain studies have focused on acute pain, passive music experiences, and in-person delivery. The purpose of this study was to examine feasibility and acceptability and determine proof-of-concept for a newly developed telehealth music imagery (MI) intervention for Veterans with chronic pain. A single-group proof-of-concept pilot study was conducted with Veterans with chronic pain (n = 8). Feasibility was assessed through examination of recruitment, retention, and session/measure completion rates; acceptability through participant interviews; and whether the intervention resulted in clinically meaningful change scores (pre- to post-intervention) on measures of pain, anxiety, and depression at the individual level. For Veterans who passed eligibility screening, we had an enrollment rate of 89%, with good retention (75%). Overall, participating Veterans found the intervention acceptable, identified specific challenges with technology, and recommended an increased number of sessions. Preliminary outcome data for pain, anxiety, and depression were mixed, with some Veterans reporting clinically meaningful improvements and others reporting no change or worsening symptoms. Findings informed modifications to the telehealth MI intervention and the design of a larger pilot randomized controlled trial to assess feasibility and acceptability of the modified intervention in a larger population of Veterans with chronic pain using additional measures and a control condition.

Protocol and biomarker strategy for a multi-site randomized controlled trial examining biological mechanisms and dosing of active music engagement in children with acute lymphoblastic leukemia and lymphoma and parents.

BACKGROUND: Music therapy is a standard palliative care service in many pediatric and adult hospitals; however, most research has focused on the use of music to improve psychosocial dimensions of health, without considering biological dimensions. This study builds on prior work examining psychosocial mechanisms of action underlying an Active Music Engagement (AME) intervention, designed to help manage emotional distress and improve positive health outcomes in young children with cancer and parents (caregivers), by examining its effects on biomarkers of stress and immune function. METHODS: This two-group randomized controlled trial (R01NR019190) is designed to examine biological mechanisms of effect and dose-response relationships of AME on child/parent stress during the consolidation phase of Acute B- or T-cell Lymphoblastic Leukemia (ALL) and T-cell Lymphoblastic Lymphoma (TLyLy) treatment. Child/parent dyads (n = 228) are stratified (by age, site, risk level) and randomized in blocks of four to the AME or attention control condition. Each group receives one session (30-minutes AME; 20-minutes control) during weekly clinic visits (4 weeks standard risk B-cell ALL; 8 weeks high risk B-cell ALL/T-cell ALL/TLyLy). Parents complete questionnaires at baseline and post-intervention. Child/parent salivary cortisol samples are taken pre- and post-session (sessions 1-4). Child blood samples are reserved from routine draws before sessions 1 and 4 (all participants) and session 8 (high risk participants). We will use linear mixed models to estimate AME's effect on child/parent cortisol. Examining child/parent cortisol as mediators of AME effects on child and parent outcomes will be performed in an ANCOVA setting, fitting the appropriate mediation models using MPlus and then testing indirect effects using the percentile bootstrap approach. Graphical plots and non-linear repeated measures models will be used to examine dose-response relationship of AME on child/parent cortisol. DISCUSSION: During pediatric cancer treatment there are special challenges that must be considered when measuring cortisol and immune function. In this manuscript we discuss how we addressed three specific challenges through our trial design. Findings from this trial will increase mechanistic understanding of the effects of active music interventions on multiple biomarkers and understanding of dose-response effects, with direct implications for clinical practice. TRIAL REGISTRATION: ClinicalTrials.gov: NCT04400071.

Mediators and Moderators of Active Music Engagement to Reduce Traumatic Stress Symptoms and Improve Well-being in Parents of Young Children With Cancer.

OBJECTIVE: This trial examined the effects of proximal/distal mediators and moderators of an Active Music Engagement (AME) intervention on young child/parent distress, quality of life, and family function outcomes. METHODS: Child/parent dyads (n = 125) were randomized to AME or Audio-storybooks attention control condition. Each group received 3 sessions with a credentialed music therapist for 3 consecutive days with data collection at baseline, post-intervention (T2), and 30-days later (T3). Potential proximal mediators included within session child and parent engagement. Potential distal mediators included changes in perceived family normalcy, parent self-efficacy, and independent use of play materials. Potential moderators included parent/child distress with prior hospitalizations, parent traumatic stress screener (PCL-6), and child age. Outcomes included child emotional distress and quality of life; parent emotion, traumatic stress symptoms (IES-R), well-being; and family function. Mediation effects were estimated using ANCOVA, with indirect effects estimated using the percentile bootstrap approach. Moderation effects were tested by including appropriate interaction terms in models. RESULTS: No significant mediation effects were observed. Child distress with prior hospitalizations moderated AME effects for IES-R intrusion subscale scores at T2 (P = .01) and avoidance subscale scores at T3 (P = .007). Traumatic stress screener scores (PCL-6) moderated intervention effects for IES-R hyperarousal subscale scores at T2 (P = .01). There were no moderation effects for child age. CONCLUSIONS: AME is a promising intervention for mitigating traumatic stress symptoms and supporting well-being in parents of children with cancer, particularly for parents who screen high for traumatic stress and whose children are more highly distressed with hospitalization.

Implementing NIH Behavior Change Consortium Treatment Fidelity Recommendations in a Multi-Site Randomized Controlled Trial of an Active Music Engagement Intervention for Young Children with Cancer and Parents.

Treatment fidelity is the use of methodological strategies to monitor and enhance reliability and validity of behavioral intervention trials. Despite availability of guidelines and checklists, treatment fidelity remains underreported, hindering evaluation, interpretation, and cross-study comparisons. Treatment fidelity is particularly important for music interventions given the inherent complexity of musical stimuli and flexibility required for tailored delivery. The purpose of this paper is to define and describe treatment fidelity strategies for our trial of a music-based play intervention for young children with cancer and parents grounded in the NIH Behavior Change Consortium Treatment Fidelity Recommendations. We report strategies for all 5 areas: study design, training providers, delivery of treatment, receipt of treatment, and enactment of treatment skills. We also discuss 4 challenges our team encountered, including: (1) standardizing live music delivery, (2) defining boundaries for tailored intervention delivery, (3) managing extended time between participants, and (4) minimizing risk for bias. This paper expands on current fidelity literature and may provide a working model for other investigators examining dyadic and/or active music interventions.

Music Therapy for Children with Oncology & Hematological Conditions and Their Families: Advancing the Standards of Psychosocial Care.

Background: Diagnosis and treatment of cancer and blood disorders in childhood, adolescence and young adulthood has a significant impact on patients and families. The Psychosocial Standards of Care project, initiated in 2012, resulted in 15 Psychosocial Standards (PSS) that guide the care patients and families receive throughout treatment. As members of the multidisciplinary psychosocial care team, music therapists play an important role in the advancing the PSS. Most surveys have focused on other commonly provided services (e.g., social work, child life), leaving gaps in our understanding about the availability and use of music therapy services to advance PSS. This paper offers an initial description of how music therapy services contribute to the provision of care under these Standards. Methods: We analyze how music therapy services promote PSS through synthesis of a music therapy clinical practice survey, published literature, and scope of practice documents. A brief overview of music therapy services structure, PSS that music therapy services currently address, and two clinical program descriptions are included. Results: Music therapy services address 9 of the 15 PSS and are well integrated within the larger program of psychosocial care. Findings suggest integration of music therapy services can help ensure personalized, comprehensive care and efficient use of often-limited psychosocial care resources. Discussion: Nurses, as members of the psychosocial and medical teams are uniquely positioned to identify patient and family care needs and refer patients for services. Understanding how music therapy services address PSS and most importantly, the needs of patients and families, will optimize their care.

Feasibility and Acceptability of Music Imagery and Listening Interventions for Analgesia: Protocol for a Randomized Controlled Trial.

BACKGROUND: Chronic pain and access to care are identified as critical needs of the Veterans Health Administration. Music imagery and music listening interventions have shown promise as effective nonpharmacological options for pain management. However, most studies have focused on acute pain, passive music experiences, and in-person delivery. OBJECTIVE: In this study, we aimed to examine the feasibility and acceptability of 2 music interventions delivered through telehealth for chronic musculoskeletal pain, trial design, and theoretical model before conducting a fully powered efficacy or comparative effectiveness trial. METHODS: FAMILIA (Feasibility and Acceptability of Music Imagery and Listening Interventions for Analgesia) is a 3-arm, parallel group, pilot trial. A total of 60 veterans will be randomized to one of the three conditions: music imagery, music listening, or usual care. Aim 1 is to test the feasibility and acceptability of a multicomponent, interactive music imagery intervention (8-weekly, individual sessions) and a single-component, minimally interactive music learning intervention (independent music listening). Feasibility metrics related to recruitment, retention, engagement, and completion of the treatment protocol and questionnaires will be assessed. Up to 20 qualitative interviews will be conducted to assess veteran experiences with both interventions, including perceived benefits, acceptability, barriers, and facilitators. Interview transcripts will be coded and analyzed for emergent themes. Aim 2 is to explore the effects of music imagery and music listening versus usual care on pain and associated patient-centered outcomes. These outcomes and potential mediators will be explored through changes from baseline to follow-up assessments at 1, 3, and 4 months. Descriptive statistics will be used to describe outcomes; this pilot study is not powered to detect differences in outcomes. RESULTS: Recruitment for FAMILIA began in March 2022, and as of July 2022, 16 participants have been enrolled. We anticipate that enrollment will be completed by May 2023. We expect that music imagery and music listening will prove acceptable to veterans and that feasibility benchmarks will be reached. We hypothesize that music imagery and music listening will be more effective than usual care on pain and related outcomes. CONCLUSIONS: FAMILIA addresses four limitations in music intervention research for chronic pain: limited studies in veterans, evaluation of a multicomponent music intervention, methodological rigor, and internet-based delivery. Findings from FAMILIA will inform a fully powered trial to identify putative mechanisms and test efficacy. TRIAL REGISTRATION: ClinicalTrials.gov NCT05426941; https://tinyurl.com/3jdhx28u. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/38788.

Randomized Clinical Trial of a Self-care and Communication Intervention for Parents of Adolescent/Young Adults Undergoing High-Risk Cancer Treatment: A Report From the Children's Oncology Group.

BACKGROUND: Parents of adolescents and young adults (AYAs) with cancer offer primary support to their children and often experience their own high levels of distress, affecting parent-AYA communication and quality of life. OBJECTIVE: To reduce parent distress and improve communication during high-risk cancer treatment, we examined efficacy of a self-care and communication intervention for parents and indirect benefit for AYAs receiving a therapeutic music video (TMV) intervention. METHODS: In this study, we conducted a multisite, randomized controlled trial with AYAs and parents enrolled as dyads (n = 110). Parents were randomized to intervention or low-dose control; all AYAs received TMV. Data collection occurred at baseline, 2 weeks post intervention (T2), and 90 days post intervention (T3). RESULTS: There were no significant between-group differences on primary outcomes for parents or AYAs. We did find significant differences favoring the parent intervention group on parenting confidence at T2 and marginally better outcomes for family adaptability/cohesion at T3. Both groups exhibited significant within-group improvement for parent distress (state anxiety, T3; perceived stress, T2 and T3; mood, T3), state anxiety (T2) intervention only, and family strengths control group only. Qualitative data demonstrate the parent intervention raised self-awareness and parent confidence in the short term. CONCLUSION: Parents found their intervention helpful. Absence of significant results may be due to short intervention duration, need for tailored content, underpowered sample, and potential indirect parent benefit from AYA participation in TMV. The parent intervention did not provide an indirect benefit for AYAs. IMPLICATIONS FOR NURSING: Parents identified their own need for communication and support from nurses. Nurses can optimize AYA care by attending to parent needs through supportive listening and encouraging self-care.

Ensuring treatment fidelity in a multi-site behavioral intervention study: implementing NIH Behavior Change Consortium recommendations in the SMART trial.

The Stories and Music for Adolescent/Young Adult Resilience during Transplant (SMART) study (R01NR008583; U10CA098543; U10CA095861) is an ongoing multi-site Children's Oncology Group randomized clinical trial testing the efficacy of a therapeutic music video intervention for adolescents/young adults (11-24 years of age) with cancer undergoing stem cell transplant. Treatment fidelity strategies from our trial are consistent with the National Institutes of Health (NIH) Behavior Change Consortium Treatment Fidelity Workgroup (BCC) recommendations and provide a successful working model for treatment fidelity implementation in a large, multi-site behavioral intervention study. In this paper, we summarize 20 specific treatment fidelity strategies used in the SMART trial and how these strategies correspond with NIH BCC recommendations in five specific areas: (1) study design, (2) training providers, (3) delivery of treatment, (4) receipt of treatment, and (5) enactment of treatment skills. Increased use and reporting of treatment fidelity procedures is essential in advancing the reliability and validity of behavioral intervention research. The SMART trial provides a strong model for the application of fidelity strategies to improve scientific findings and addresses the absence of published literature, illustrating the application of BCC recommendations in behavioral intervention studies.

Development and use of a web-based data management system for a randomized clinical trial of adolescents and young adults.

Recent advances in technology provide support for multisite, Web-based data-entry systems and the storage of data in a centralized location, resulting in immediate access to data for investigators, reduced participant burden and human entry error, and improved integrity of clinical trial data. The purpose of this article was to describe the development of a comprehensive, Web-based data management system for a multisite randomized behavioral intervention trial. Strategies used to create this study-specific data management system included interdisciplinary collaboration, design mapping, feasibility assessments, and input from an advisory board of former patients with characteristics similar to the targeted population. The resulting data management system and development strategies provide a template for other behavioral intervention studies.

Visiting Scholars Program to enhance career development among early-career KL2 investigators in Clinical and Translational Science: Implications from a quality improvement assessment.

CTSI Career Development Award (KL2) programs provide junior faculty with protected time and multidisciplinary, mentored research training in clinical and translational science research. The KL2 Visiting Scholars Program was developed to promote collaborative cross-CTSA training, leverage academic strengths at host CTSAs, and support the career development of participating scholars through experiential training and the development of new partnerships. This manuscript provides a detailed programmatic description and reports outcomes from post-visit and outcomes surveys. Since 2016, 12 scholars have completed the program, with 6 scheduled to complete it in 2021. Post-visit surveys (n = 12) indicate all scholars reported the program valuable to career development, 11 reported benefit for research development, and 11 expansion of collaborative networks. Outcomes surveys (n = 11) revealed subsequent scholar interaction with host institution faculty for 10 scholars, 2 collaborative grant submissions (1 funded), 2 planned grant submissions, 1 published collaborative manuscript, and 3 planned manuscript/abstract submissions. The Visiting Scholars Program is a cost- and time-efficient program that leverages the academic strengths of CTSAs. The program enhanced KL2 scholar training by expanding their professional portfolio, promoting research development, and expanding collaborative networks. Resources to support the program are shared in this report to expedite the development of similar programs at regional and national levels.