Background Human papillomavirus (HPV) vaccine hesitancy is on the rise, and provider communication is a first-line strategy to address parental concerns. The use of the presumptive approach and motivational interviewing by providers may not be enough to influence parental decision-making owing to the providers’ limited time, self-efficacy, and skills to implement these strategies. Interventions to enhance provider communication and build parental HPV vaccine confidence have been undertested. Delivering tailored patient education to parents via mobile phones before they visit the health care provider may address time constraints during clinic visits and positively affect vaccine uptake. Objective This study aimed to describe the development and evaluate the acceptability of a mobile phone–based, family-focused intervention guided by theory to address concerns of HPV vaccine–hesitant parents before the clinic visit, as well as explore intervention use to facilitate parent-child communication. Methods The health belief model and theory of reasoned action guided intervention content development. A multilevel stakeholder engagement process was used to iteratively develop the HPVVaxFacts intervention, including a community advisory board review, a review by an advisory panel comprising HPV vaccine–hesitant parents, a health communications expert review, semistructured qualitative interviews with HPV vaccine–hesitant parents (n=31) and providers (n=15), and a content expert review. Inductive thematic analysis was used to identify themes in the interview data. Results The qualitative interviews yielded 4 themes: overall views toward mobile device use for health information, acceptability of HPVVaxFacts, facilitators of HPVVaxFacts use, and barriers to HPVVaxFacts use. In parent interviews after reviewing HPVVaxFacts prototypes, almost all parents (29/31, 94%) stated they intended to have their child vaccinated. Most of the parents stated that they liked the added adolescents’ corner to engage in optional parent-child communication (ie, choice to share and discuss information with their child; 27/31, 87%) and shared decision-making in some cases (8/31, 26%). After incorporating all input, the final intervention consisted of a 10-item survey to identify the top 3 concerns of parents, followed by tailored education that was mapped to each of the following concerns: evidential messages, images or graphics to enhance comprehension and address low literacy, links to credible websites, a provider video, suggested questions to ask their child’s physician, and an optional adolescents’ corner to educate the patient and support parent-child communication. Conclusions The multilevel stakeholder-engaged process used to iteratively develop this novel intervention for HPV vaccine–hesitant families can be used as a model to develop future mobile health interventions. This intervention is currently being pilot-tested in preparation for a randomized controlled trial aiming to increase HPV vaccination among adolescent children of vaccine-hesitant parents in a clinic setting. Future research can adapt HPVVaxFacts for other vaccines and use in other settings (eg, health departments and pharmacies).
BACKGROUND Human papillomavirus (HPV) vaccine hesitancy is on the rise, and provider communication is a first-line strategy to address parental concerns. The use of the presumptive approach and motivational interviewing by providers may not be enough to influence parental decision-making owing to the providers’ limited time, self-efficacy, and skills to implement these strategies. Interventions to enhance provider communication and build parental HPV vaccine confidence have been undertested. Delivering tailored patient education to parents via mobile phones before they visit the health care provider may address time constraints during clinic visits and positively affect vaccine uptake. OBJECTIVE This study aimed to describe the development and evaluate the acceptability of a mobile phone–based, family-focused intervention guided by theory to address concerns of HPV vaccine–hesitant parents before the clinic visit, as well as explore intervention use to facilitate parent-child communication. METHODS The health belief model and theory of reasoned action guided intervention content development. A multilevel stakeholder engagement process was used to iteratively develop the <i>HPVVaxFacts</i> intervention, including a community advisory board review, a review by an advisory panel comprising HPV vaccine–hesitant parents, a health communications expert review, semistructured qualitative interviews with HPV vaccine–hesitant parents (n=31) and providers (n=15), and a content expert review. Inductive thematic analysis was used to identify themes in the interview data. RESULTS The qualitative interviews yielded 4 themes: overall views toward mobile device use for health information, acceptability of <i>HPVVaxFacts</i>, facilitators of <i>HPVVaxFacts</i> use, and barriers to <i>HPVVaxFacts</i> use. In parent interviews after reviewing <i>HPVVaxFacts</i> prototypes, almost all parents (29/31, 94%) stated they intended to have their child vaccinated. Most of the parents stated that they liked the added <i>adolescents’ corner</i> to engage in optional parent-child communication (ie, choice to share and discuss information with their child; 27/31, 87%) and shared decision-making in some cases (8/31, 26%). After incorporating all input, the final intervention consisted of a 10-item survey to identify the top 3 concerns of parents, followed by tailored education that was mapped to each of the following concerns: evidential messages, images or graphics to enhance comprehension and address low literacy, links to credible websites, a provider video, suggested questions to ask their child’s physician, and an optional adolescents’ corner to educate the patient and support parent-child communication. CONCLUSIONS The multilevel stakeholder-engaged process used to iteratively develop this novel intervention for HPV vaccine–hesitant families can be used as a model to develop future mobile health interventions. This intervention is currently being pilot-tested in preparation for a randomized controlled trial aiming to increase HPV vaccination among adolescent children of vaccine-hesitant parents in a clinic setting. Future research can adapt <i>HPVVaxFacts</i> for other vaccines and use in other settings (eg, health departments and pharmacies).
BACKGROUND Few adolescents who experience depression or anxiety connect to mental health treatment. Supporting Our Valued Adolescents (SOVA) is a stakeholder-informed technology intervention that consists of 2 blog-format websites—one for adolescents and another for parents. SOVA is designed to intervene on targets, which may increase the mental health treatment uptake when adolescents with depression or anxiety are identified in primary care settings. OBJECTIVE This study aims to describe the protocol for a pilot randomized controlled trial designed to refine recruitment and retention strategies, document intervention fidelity and implementation outcomes, and assess changes in health beliefs and knowledge, emotional or informational support, and parent-adolescent communication quality in adolescents and their parents. METHODS Adolescents identified with symptoms of depression or anxiety, for which a health care provider recommends treatment, and their parents will be recruited from clinics where adolescents are seen for primary care. Adolescent-parent dyads will be randomized at 1:1 to both receive the SOVA websites and enhanced usual care or enhanced usual care alone. Baseline measures and 6-week and 3-month outcomes will be collected by Web-based self-report surveys and electronic health record review. The main pilot outcome is the 6-week study retention rate. Analyses will also assess changes in health beliefs and knowledge, emotional support, and parent-adolescent communication in both adolescents and their parents. RESULTS The project was funded in 2017. Recruitment commenced in April 2018 and enrollment is ongoing, with completion anticipated at the end of 2019 with subsequent plans for data analysis and publication submission in early 2020. CONCLUSIONS The findings of this research will inform the design of a multisite hybrid effectiveness-implementation randomized controlled trial examining the effectiveness and optimal implementation strategies for using SOVA in community primary care settings. CLINICALTRIAL ClinicalTrials.gov NCT03318666; https://clinicaltrials.gov/ct2/show/NCT03318666 INTERNATIONAL REGISTERED REPOR PRR1-10.2196/12117
Background Adolescents with depression or anxiety initiate mental health treatment in low numbers. Supporting Our Valued Adolescents (SOVA) is a peer support website intervention for adolescents seen in primary care settings and their parents with the goal of increasing treatment uptake through changing negative health beliefs, enhancing knowledge, offering peer emotional support, and increasing parent-adolescent communication about mental health. Objective This pilot study aimed to refine recruitment and retention strategies, refine document intervention fidelity, and explore changes in study outcomes (the primary outcome being treatment uptake). Methods We conducted a 2-group, single-blind, pilot randomized controlled trial in a single adolescent medicine clinic. Participants were aged 12 to 19 years with clinician-identified symptoms of depression or anxiety for which a health care provider recommended treatment. The patient and parent, if interested, were randomized to receive the SOVA websites and enhanced usual care (EUC) compared with EUC alone. Baseline, 6-week, and 3-month measures were collected using a web-based self-report survey and blinded electronic health record review. The main pilot outcomes assessed were the feasibility of recruitment and retention strategies. Implementation outcomes, intervention fidelity, missingness, and adequacy of safety protocols were documented. Descriptive statistics were used to summarize mental health service use and target measures with 2-sample t tests to compare differences between arms. Results Less than half of the adolescents who were offered patient education material (195/461, 42.2%) were referred by their clinician to the study. Of 146 adolescents meeting the inclusion criteria, 38 completed the baseline survey, qualifying them for randomization, and 25 (66%, 95% CI 51%-81%) completed the 6-week measures. There was limited engagement in the treatment arm, with 45% (5/11) of adolescents who completed 6-week measures reporting accessing SOVA, and most of those who did not access cited forgetting as the reason. Changes were found in target factors at 6 weeks but not in per-protocol analyses. At 12 weeks, 83% (15/18) of adolescents randomized to SOVA received mental health treatment as compared with 50% (10/20) of adolescents randomized to EUC (P=.03). Conclusions In this pilot trial of a peer support website intervention for adolescents with depression or anxiety, we found lower-than-expected study enrollment after recruitment. Although generalizability may be enhanced by not requiring parental permission for adolescent participation in the trials of mental health interventions, this may limit study recruitment and retention. We found that implementing education introducing the study into provider workflow was feasible and acceptable, resulting in almost 500 study referrals. Finally, although not the primary outcome, we found a signal for greater uptake of mental health treatment in the arm using the SOVA intervention than in the usual care arm. Trial Registration ClinicalTrials.gov NCT03318666; https://clinicaltrials.gov/ct2/show/NCT03318666 International Registered Report Identifier (IRRID) RR2-10.2196/12117
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