Dataset Information

Parental consent: A potential barrier for underage teens' participation in an mHealth mental health intervention.

ABSTRACT: Purpose:We sought to examine whether underage adolescents displaying symptoms for a mental illness (i.e., an eating disorder) would be willing to obtain parental consent to participate in a study to test the efficacy of an evidence-based mobile mental health intervention targeting teens with eating disorders. Methods:The participants (n = 366) were 15 to 17 year-old English-speakers who post or follow social media accounts on Instagram that emphasize being thin as important or attractive. The participants were administered a survey through Qualtrics to assess eating disorder pathology, interest in trying an evidence-based mobile mental-health intervention, and comfort level with obtaining parental consent to partake in a research study about such an intervention. Results:About 85% of participants met clinical or subclinical criteria for an eating disorder; however, only 12% had received a treatment within the past six months. While 83% of participants were interested in trying a mobile health interventions app, only 35% indicated willingness to obtain parental consent to participate in a research study. The primary reasons presented for unwillingness to obtain consent included importance of retaining privacy and feeling that parents lack awareness or understanding about mental health issues. Conclusions:While barriers exist to obtaining treatment for eating disorders, a mobile intervention app may close some of these gaps. Many underage participants indicated interest in obtaining such treatment, yet only a third were willing to obtain parental consent. Future studies should investigate how to reduce these barriers to obtaining parental consent to facilitate teen access to research and mobile mental health treatment.

SUBMITTER: Cavazos-Rehg P

PROVIDER: S-EPMC7276447 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Parental consent: A potential barrier for underage teens' participation in an mHealth mental health intervention.

Cavazos-Rehg Patricia P Min Caroline C Fitzsimmons-Craft Ellen E EE Savoy Bria B Kaiser Nina N Riordan Raven R Krauss Melissa M Costello Shaina S Wilfley Denise D

Internet interventions 20200520

<h4>Purpose</h4>We sought to examine whether underage adolescents displaying symptoms for a mental illness (i.e., an eating disorder) would be willing to obtain parental consent to participate in a study to test the efficacy of an evidence-based mobile mental health intervention targeting teens with eating disorders.<h4>Methods</h4>The participants (<i>n</i> = 366) were 15 to 17 year-old English-speakers who post or follow social media accounts on Instagram that emphasize being thin as important ...[more]

PMID: 32528858

Similar Datasets

Project description:ImportanceObtaining informed consent is an important ethical obligation for clinical research participation that is imperfectly implemented. Research on improving consent processes often focuses on consent forms, but little is known about consent forms' influence on decision-making compared with other types of engagement.ObjectiveTo evaluate whether parents decide whether to enroll their children in research before or after they receive the consent form.Design, setting, and participantsAn online survey of 88 parents who enrolled or declined to enroll their child in a weight management intervention study between January 2, 2018, and June 24, 2019, was conducted; surveys were completed between February 2, 2018, and July 9, 2019. A 31-item survey asked about impressions of the study throughout the enrollment process, timing of enrollment decisions, and decision-making factors. Responses were summarized descriptively and subgroups were compared using the Fisher exact test or χ2 test.Main outcomes and measuresSelf-reported timing of enrollment decision.ResultsA total of 106 parents were approached and gave permission for their contact information to be shared with the study team; 22 additional parents declined to allow their information to be shared, and 24 lost contact with the partner study before they could be asked for permission. A total of 88 parents (67 enrollees, 21 decliners) completed the survey (83% participation rate); 79 of 88 reporting gender (instead of sex, as biological sex was not relevant to survey) information were women (91%), 66 participants (75%) were non-Hispanic White, and 63 participants (72%) had annual household incomes greater than or equal to $70 000. No significant differences in respondent characteristics between enrollees and decliners were identified. Fifty-nine parents (67%) responded that they decided whether to enroll in the weight management study before receiving the consent form. Only 17 of 69 parents (25%) who remembered receiving the consent form responded that it taught them new information.Conclusions and relevanceThe findings of this study suggest that interventions to improve informed consent forms may have limited influence on decision-making because many research decisions occur before review of the consent form. It appears that regulatory review and interventions to improve decision-making should focus more on early engagement (eg, recruitment materials). Future studies should test timing of decisions in other types of research with different populations and clinical settings.

Project description:IntroductionTime-critical neonatal trials in low-and-middle-income countries (LMICs) raise several ethical issues. Using a qualitative-dominant mixed-methods design, we explored informed consent process in Hypothermia for encephalopathy in low and middle-income countries (HELIX) trial conducted in India, Sri Lanka and Bangladesh.MethodsTerm infants with neonatal encephalopathy, aged less than 6 hours, were randomly allocated to cooling therapy or usual care, following informed parental consent. The consenting process was audio-video (A-V) recorded in all cases. We analysed A-V records of the consent process using a 5-point Likert scale on three parameters-empathy, information and autonomy. In addition, we used exploratory observation method to capture relevant aspects of consent process and discussions between parents and professionals. Finally, we conducted in-depth interviews with a subgroup of 20 parents and 15 healthcare professionals. A thematic analysis was performed on the observations of A-V records and on the interview transcripts.ResultsA total of 294 A-V records of the HELIX trial were analysed. Median (IQR) score for empathy, information and autonomy was 5 (0), 5 (1) and 5 (1), respectively. However, thematic analysis suggested that the consenting was a ceremonial process; and parental decision to participate was based on unreserved trust in the treating doctors, therapeutic misconception and access to an expensive treatment free of cost. Most parents did not understand the concept of a clinical trial nor the nature of the intervention. Professionals showed a strong bias towards cooling therapy and reported time constraints and explaining to multiple family members as key challenges.ConclusionDespite rigorous research governance and consent process, parental decisions were heavily influenced by situational incapacity and a trust in doctors to make the right decision on their behalf. Further research is required to identify culturally and context-appropriate strategies for informed trial participation.

Project description:BACKGROUND:Young gay and bisexual men (YGBM) in some Eastern European countries, such as Romania, face high stigma and discrimination, including in health care. Increasing HIV transmission is a concern given inadequate prevention, travel to high-prevalence countries, and popularity of sexual networking technologies. OBJECTIVE:This study aimed to adapt and pilot test, in Romania, a preliminarily efficacious mobile health (mHealth) HIV-prevention intervention, created in the United States, to reduce HIV risk among YGBM. METHODS:After an intervention formative phase, we enrolled 43 YGBM, mean age 23.2 (SD 3.6) years, who reported condomless sex with a male partner and at least 5 days of heavy drinking in the past 3 months. These YGBM completed up to eight 60-minute text-based counseling sessions grounded in motivational interviewing and cognitive behavioral skills training with trained counselors on a private study mobile platform. We conducted one-group pre-post intervention assessments of sexual (eg, HIV-risk behavior), behavioral (eg, alcohol use), and mental health (eg, depression) outcomes to evaluate the intervention impact. RESULTS:From baseline to follow-up, participants reported significant (1) increases in HIV-related knowledge (mean 4.6 vs mean 4.8; P=.001) and recent HIV testing (mean 2.8 vs mean 3.3; P=.05); (2) reductions in the number of days of heavy alcohol consumption (mean 12.8 vs mean 6.9; P=.005), and (3) increases in the self-efficacy of condom use (mean 3.3 vs mean 4.0; P=.01). Participants reported significant reductions in anxiety (mean 1.4 vs mean 1.0; P=.02) and depression (mean 1.5 vs mean 1.0; P=.003). The intervention yielded high acceptability and feasibility: 86% (38/44) of participants who began the intervention completed the minimum dose of 5 sessions, with an average of 7.1 sessions completed; evaluation interviews indicated that participation was rewarding and an "eye-opener" about HIV risk reduction, healthy identity development, and partner communication. CONCLUSIONS:This first mHealth HIV risk-reduction pilot intervention for YGBM in Eastern Europe indicates preliminary efficacy and strong acceptability and feasibility. This mobile prevention tool lends itself to broad dissemination across various similar settings pending future efficacy testing in a large trial, especially in contexts where stigma keeps YGBM out of reach of affirmative health interventions.

Project description:Consumer-based physical activity (PA) trackers, also known as wearables, are increasingly being used in research studies as intervention or measurement tools. One of the most popular and widely used brands of PA trackers is Fitbit. Since the release of the first Fitbit in 2009, hundreds of experimental studies have used Fitbit devices to facilitate PA self-monitoring and behavior change via goal setting and feedback tools. Fitbit's ability to capture large volumes of PA and physiological data in real time creates enormous opportunities for researchers. At the same time, however, it introduces a number of challenges (eg, technological, operational, logistical), most of which are not sufficiently described in study publications. Currently, there are no technical reports, guidelines, nor other types of publications discussing some of these challenges and offering guidance to researchers on how to best incorporate Fitbit devices in their study design and intervention to achieve their research goals. As a result, researchers are often left alone to discover and address some of these issues during the study through "trial and error." This paper aims to address this gap. Drawing on our cumulative experience of conducting multiple studies with various Fitbit PA trackers over the years, we present and discuss various key challenges associated with the use of Fitbit PA trackers in research studies. Difficulties with the use of Fitbit PA trackers are encountered throughout the entire research process. Challenges and solutions are categorized in 4 main categories: study preparation, intervention delivery, data collection and analysis, and study closeout. Subsequently, we describe a number of empirically tested strategies used in 4 of our interventional studies involving participants from a broad range of demographic characteristics, racial/ethnic backgrounds, and literacy levels. Researchers should be prepared to address challenges and issues in a timely fashion to ensure that the Fitbit effectively assists participants and researchers in achieving research and outcome goals.

Dataset Information

Parental consent: A potential barrier for underage teens' participation in an mHealth mental health intervention.

Publications

Parental consent: A potential barrier for underage teens' participation in an mHealth mental health intervention.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets