This research will be conducted in two phases: development and pilot. The purpose of the development phase is to conduct formative research with parents and adolescents with T1D and their providers in order to adapt the program to a Web-based format. The pilot phase will assess feasibility of this approach. Each phase is described below. Ethical approval was provided by the Institutional Review Board at Baylor College of Medicine (H-37245). Because the purpose of this trial is to establish the feasibility of this approach versus a randomized control trial to determine efficacy or effectiveness, the trial has not been registered with a trial registry accredited by the World Health Organization.

The content and structure of the original FT was grounded in social cognitive theory (SCT) [26]. The adaptation of FT to FTO will be guided by Computers As Persuasive Technologies (CAPTOLOGY) [27] and self-determination theory (SDT) [28]. CAPTOLOGY provides a framework for understanding how computers can be used as a persuasive mechanism to intentionally change attitudes and behaviors. For example, computers can personalize the encounter (eg, greeting family members by name), provide an interactive versus didactic session, simulate experiences (eg, provide opportunities for the parent/adolescent dyad to practice skills taught in the session), and receive tailored feedback based on responses, problems, or issues brought up in the session [27]. The framework posits that this is achieved through the “functional triad,” which is a unique combination of the tool (eg, access device, such as a computer or tablet), medium (eg, delivery mode, such as the Internet), and social actor (eg, relationship builder, such as the relational agent) [27]. SDT [28] contends that three basic needs drive behavior: competence (ie, knowledge, skills, ability to successfully perform a behavior), autonomy (ie, choice, control), and relatedness (ie, connection to important others). A high level of need satisfaction promotes internalization and integration of the behavior into one’s sense of self (ie, “I am a person who routinely monitors my BG,” “I am a person who tries to understand my parent’s perspective when we disagree over my diabetes”). Internalization and integration of a behavior with one’s sense of self increases internally driven motivation to perform the behavior. This, in turn, increases the likelihood that the behavior will be performed and maintained over time [28]. The relational agent will be constructed to emphasize need fulfillment. For example, it will enhance effective communication among parents and adolescents around T1D self-management behaviors by presenting skills, encouraging practice (ie, competence), and emphasizing personal choice regarding how they interpret comments and respond to each other (ie, autonomy). Improved communication will provide insight into what the other person’s motivations may be when they react in a certain way, and it will help establish a bond of trust and rapport with the relational agent (ie, relatedness). Figure 1 shows the conceptual model guiding the adaptation.

Health care providers at a diabetes care center in a large tertiary care children’s hospital in the southwestern United States are eligible if they are employed full or part time by the facility. They will be invited by email to participate in the first phase of the study.

Current patients and their primary diabetes caregivers attending a large diabetes care center in Texas are eligible to participate in this study: 10-14 year olds with T1D as defined by the American Diabetes Association criteria [29], disease duration at least 1 but not over 5 years, fluent in English with access to high-speed Internet, and a parent willing to participate in the study are eligible to participate. Adolescents are ineligible if the average HbA1c over the past year is ≥12% (due to a greater likelihood of having psychiatric conditions [30]) or ˂7% (excellent glycemic control), unable to attend regular clinic visits, or have a physical/mental disease or condition that may conflict with study protocol and limit ability to complete data collection activities or participate in the intervention.

Eligible parents must be the primary caregiver of a child with T1D enrolled in the study, be willing to participate in study activities, be fluent in English, have access to high-speed Internet, and not be planning to leave the geographic area.

To identify families, a research coordinator experienced in working with families with diabetes will screen the clinic appointment schedule to identify families who meet the eligibility criteria. Eligible families will be invited by letter to participate. Within a week of sending the letter, study staff will contact the families to answer questions, ascertain interest, and screen for eligibility. If families are interested and eligible, written informed consent and child assent will be obtained.

The purpose of this phase is to conduct formative research to adapt FT for Web-based delivery by a relational agent. It consists of in-person interviews with health care providers, Web-based surveys and telephone interviews with parents and adolescents, in-person usability testing with parents and adolescents, and development of a brief instructional video and supporting materials to facilitate intervention completion.

We anticipate that feasibility criteria will be met and that families in the FTO group will have favorable changes in the expected directions.

The Diabetes Control and Complications Trial and its findings heightened awareness of the critical importance of maintaining near-normal BG levels to delay and/or prevent T1D complications [51]. Adolescents are particularly affected by poor adherence to the demanding T1D regimen. Family conflict and negative communication around diabetes management, especially around BG monitoring, are barriers to adolescent adherence to their treatment plan [14]. A meta-analysis of pediatric T1D interventions with adherence-promoting components concluded that behavioral interventions focusing “on direct, behavioral processes and neglected emotional, social and family processes are unlikely to have an impact on BG control” (p. 1658) [52]. The most efficacious interventions addressed both [52]. The FT intervention meets these criteria: it targets interactions of the parent and adolescent with T1D and addresses T1D management behaviors (eg, BG monitoring, administering insulin, carbohydrate counting).

Although face-to-face interactions with health care providers have historically been thought of as the most effective method for achieving health behavior change and are considered the “gold standard” [18,53], limited reach [53], time [18], and consistency in intervention delivery can reduce effectiveness [18]. Relational agents may help overcome these limitations. They simulate characteristics of face-to-face interactions with a health care provider, including verbal and nonverbal behaviors that contribute to trust, rapport, and relationship-building. Programs delivered by relational agents are also convenient, accessible, and likely cost effective, particularly when delivered online [18].

Relational agents have been utilized in a variety of populations and health behaviors [16-23] . However, to our knowledge, they have not been used to enhance family communication around T1D in adolescence. Because research shows promising evidence that relational agents can establish a therapeutic relationship with patients and that they are accepted by a wide variety of patient populations [18,19], relational agents have the potential to enhance reach and public health impact of efficacious interventions by overcoming limitations associated with face-to-face delivery. Thus, if proven feasible, this research has the potential to ultimately impact how health education programs are delivered to families of adolescents with T1D and other chronic diseases in which effective family communication is essential.

Limitations of this research include conducting the research in one geographic region of the United States, which may limit generalizability. However, this is a pilot study, seeking to establish feasibility and proof of concept, which somewhat overcomes this concern at this stage of intervention development. The sample size is also small; however, once feasibility is established, fully powered efficacy and effectiveness trials can be conducted with larger, more diverse samples. Self-report questionnaires are also used to report psychological information. However, objective measures of adherence will be captured by retrieving BG meter readings and other health outcomes, such as lab values of glycemic control (HbA1c), from the electronic health record. However, whenever possible, gold standard measures will be used in order to obtain the best information possible.

In conclusion, this research is novel and has the potential to make an important contribution to the scientific literature by expanding the reach and thus the public health impact of programs typically delivered in-person to families that have a child or adolescent with T1D.