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

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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

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Project description:Importance:Obtaining 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. Objective:To evaluate whether parents decide whether to enroll their children in research before or after they receive the consent form. Design, Setting, and Participants:An 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 ?2 test. Main Outcomes and Measures:Self-reported timing of enrollment decision. Results:A 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 Relevance:The 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: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.

Project description:BackgroundInvolving children in research studies requires obtaining parental permission. A school-based intervention to delay/prevent waterpipe use for 7th and 8th graders in Qatar was developed, and parental permission requested. Fifty three percent (2308/4314) of the parents returned permission forms; of those 19.5% of the total (840/4314) granted permission. This paper describes the challenges to obtaining parental permission. No research to date has described such challenges in the Arab world.MethodsA random sample of 40 schools in Doha, Qatar was selected for inclusion in the original intervention. Permission forms were distributed to parents for approval of their child's participation. The permission forms requested that parents indicate their reasons for non-permission if they declined. These were categorized into themes. In order to understand reasons for non-permission, interviews with parents were conducted. Phone numbers of parents were requested from the school administration; 12 of the 40 schools (30%) agreed to provide the contact information. A random sample of 28 parents from 12 schools was interviewed to reach data saturation. Thematic analysis was used to analyze their responses.ResultsReasons for non-permission documented in both the forms and interviews included: poor timing; lack of interest; the child not wanting to participate; and the child living in a smoke-free environment. Interviews provided information on important topics to include in the consent forms, parents' decision-making processes regarding their child's participation, and considerations for communicating with parents. Many parents also indicated that this was the first time they had been asked to give an informed consent for their child's participation in a study.ConclusionsResults indicate that more attention needs to be given to the informed parental consent process. Researchers should consider enhancing both the methods of communicating information as well the specific information provided. Before embarking on recruitment of children for studies, formative research on the parental consent process is suggested.

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

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

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