Satisfaction With Participation in the First STEPS Behavioral Intervention: Experiences of Parents of Young Children With Newly Diagnosed Type 1 Diabetes.

OBJECTIVE: Parents of young children with new-onset type 1 diabetes (T1D) often experience significant distress and struggle with T1D management during a challenging developmental stage. The First STEPS (Study of Type 1 in Early childhood and Parenting Support) trial evaluated a stepped-care behavioral intervention comprising increasingly intensive intervention steps (peer parent coach, cognitive-behavioral counseling, consultations with diabetes educator and psychologist) based on need. The intervention improved parental depressive symptoms compared to usual care. Subsequently, we examined parent satisfaction with the intervention to guide potential implementation and refinement for future trials. METHODS: Participants were 157 parents of young children newly diagnosed with T1D. At 9 months post randomization, n = 153 completed satisfaction questionnaires and n = 17 completed qualitative interviews. Satisfaction ratings about trial procedures and each intervention step were summarized. We used thematic analysis with the interview transcripts to generate themes related to participants' experiences in the trial overall and intervention specifically. We explored differences in themes between participants who did versus did not respond to the intervention and among those who experienced different intervention steps. RESULTS: Most participants in both arms rated study participation and methods positively (>95%), and those completing interviews described high satisfaction with study procedures overall, retention incentives, and contact with study staff. Intervention participants' satisfaction ratings were high across steps. Two qualitative themes reflected satisfaction with the intervention enhancing self-efficacy and social support. CONCLUSIONS: High satisfaction suggests implementing a stepped-care behavioral intervention as part of routine clinical care following T1D diagnosis would be well received.

Development and delivery of a brief family behavioral intervention to support continuous glucose monitor use in young children with type 1 diabetes.

BACKGROUND: Despite potential glycemic benefits of continuous glucose monitor (CGM) use in young children with type 1 diabetes, psychosocial and behavioral challenges may interfere with sustained use. We developed a 5-session family behavioral intervention (FBI) to support CGM use. OBJECTIVE: We report on the multi-step development of the FBI, training interventionists, implementation in a 14-site clinical trial, and participant satisfaction. METHODS: A multidisciplinary team created the FBI based on mixed-methods (i.e., survey data, qualitative research) preliminary work with parents of young children. Investigators trained non-physician staff to deliver the 5 sessions per an intervention manual. Trial participants received the FBI either during the first (FBI group, n = 50) or second 6-months (Crossover group, n = 44) of the 1-year trial. Investigators listened to session recordings to rate intervention fidelity, and participants rated satisfaction with the FBI. RESULTS: The complete 5-session FBI was delivered to 89% of participants, in-person (73%) or by telephone (23%). Sessions lasted 23 min on average, and fidelity was high across sessions. Over 80% of participants rated very high satisfaction with all aspects of the FBI and offered few recommendations for improvement. CONCLUSIONS: Having been developed based on experiences and input of families of young children with type 1 diabetes, the FBI represented a novel behavioral approach to enhance sustained CGM use during a challenging developmental period. Evidence of strong feasibility and acceptability supports its potential for implementation in research and clinical care. As diabetes technologies evolve, the FBI may continue to be refined to address parents' most relevant concerns.

Implementation and Preliminary Feasibility of an Individualized, Supportive Approach to Behavioral Care for Parents of Young Children Newly Diagnosed With Type 1 Diabetes.

There are significant stressors related to parenting a young child with newly diagnosed type 1 diabetes (T1D). Despite these challenges, there are not yet clearly defined interventions to help promote psychological health and adherence for families with young children with T1D. First STEPS is a tailored stepped care design intervention to positively impact parents' emotional functioning and children's glycemic control in young children newly diagnosed with T1D. The First STEPS intervention is derived from a combination of Cognitive Behavioral Theory and Social Cognitive Theory to support family adjustment to T1D, promote parental mastery over T1D tasks, increase coping skills to manage stressors associated with T1D, and build on the strengths of families newly diagnosed with T1D to help them achieve positive health and wellbeing outcomes. We present details about the intervention and describe two pilot participants as case studies. Results indicated that the treatment and delivery model were acceptable to the pilot participants, as evidenced by treatment completion and satisfaction ratings. Future directions for this work include testing the efficacy of this new treatment in a randomized controlled trial.

Neuropsychological and socioeconomic outcomes in adult survivors of pediatric low-grade glioma.

BACKGROUND: Current estimates suggest that 75% of children diagnosed with a central nervous system (CNS) tumor will become 5-year survivors. However, survivors of childhood CNS tumors are at increased risk for long-term morbidity. METHODS: To determine long-term neuropsychological and socioeconomic status (SES) outcomes, adult survivors of pediatric low-grade gliomas (n = 181) in the Childhood Cancer Survivor Study and a sibling comparison group that was frequency-matched by age and sex (n = 105) completed a comprehensive battery of standardized neuropsychological tests and an SES assessment. Multivariable regression models compared treatment-specific groups for neuropsychological and SES outcomes and evaluated associations with tumor location, age at diagnosis, sex, and age at evaluation. RESULTS: In adjusted models, survivors treated with surgery and radiotherapy (surgery+RT; median age at diagnosis, 7 years; median age at assessment, 41 years) scored lower on estimated IQ than survivors treated with surgery only, who scored lower than siblings (surgery+RT, 93.9; surgery only, 101.2; siblings, 108.5; all P values <.0001). Survivors diagnosed at younger ages had low scores for all outcomes (P < .05) except for attention/processing speed. For SES outcomes, survivors treated with surgery+RT had lower occupation scores (odds ratio [OR], 2.6; 95% confidence interval [CI], 1.1-5.9), lower income (OR, 2.6; 95% CI, 1.3-5.0), and less education (OR, 2.1; 95% CI, 1.1-4.0) than those treated with surgery only. CONCLUSIONS: Decades after treatment, survivors treated with radiotherapy and at younger ages had poorer neuropsychological and SES outcomes. Lifelong surveillance of survivors of pediatric low-grade gliomas may be warranted as life events, stages, and transitions (employment, family, and aging) present new challenges and risks.

Experiences of Parent Coaches in an Intervention for Parents of Young Children Newly Diagnosed with Type 1 Diabetes.

OBJECTIVES: This paper explores parent coaching experiences supporting parents of young children newly diagnosed with type 1 diabetes in a clinical trial. METHODS: In a trial for 157 parents, those in the intervention arm (n = 116) were paired with a parent coach (n = 37; Mage = 37.9 years, SD = 3.9; 94.6% mothers, 81.1% White non-Hispanic). Parent coaches provided diabetes-specific social support. Parent coaches completed monthly surveys and satisfaction/feasibility surveys, with a subset (n = 7) undergoing qualitative interviews at the end of this study. RESULTS: There were 2262 contacts between participants and their parent coaches, averaging 14.4 (SD = 9.3) per participant. Parent coaches reported that the most commonly used methods were text messages (67.9%) and emails (18.7%), with 33.6% having in-person visits. Coaches reported high satisfaction and belief in their usefulness to participants during the first 9 months after T1D diagnosis. Themes discussed by parent coaches about their experience in mentoring included relationship building, expertise sharing, personal growth, gratification, and intervention optimization suggestions. CONCLUSIONS: Parent coaching post T1D diagnosis involves regular, multi-method contacts. It is highly acceptable and valuable for parent coaches to mentor other parents of young children newly diagnosed with T1D.

DiaBetter Together: Clinical trial protocol for a strengths-based Peer Mentor intervention for young adults with type 1 diabetes transitioning to adult care.

BACKGROUND: Type 1 diabetes (T1D) management is challenging for young adults, who are expected to transfer from the pediatric to adult T1D healthcare system while also managing typical developmental demands (e.g., social, financial, work/school, residential). Many young adults have extended gaps in care before following up in adult care, increasing risk for poor health outcomes. There are few evidence-based programs to support young adults with T1D to promote a timelier transition during this period. This paper reports on the design of DiaBetter Together, a randomized controlled trial to evaluate a 12-month Peer Mentor-delivered intervention compared to usual care among young adults with T1D during the transfer from pediatric to adult care. METHODS: One-hundred young adults (age 17-25) with T1D and 29 Peer Mentors enrolled in this randomized clinical trial. Peer Mentors are experienced, older young adults with T1D, trained by the study team to share transition experiences and strategies to successfully navigate the adult healthcare system, help young adults prepare for the first adult care visit, and use strengths-based support strategies to teach and model skills for managing T1D-related challenges. RESULTS: The primary outcome of the trial is HbA1c, and secondary outcomes include time to adult care, engagement in diabetes self-management behaviors, and psychosocial well-being. CONCLUSION: The goal of this research is to evaluate a developmentally appropriate, supportive intervention that can improve T1D self-management and successful transfer of care during the difficult young adult years and promote optimal T1D health outcomes.

First STEPS: Primary Outcomes of a Randomized, Stepped-Care Behavioral Clinical Trial for Parents of Young Children With New-Onset Type 1 Diabetes.

OBJECTIVE: Despite the emotional challenges of parental adjustment to a child's type 1 diabetes diagnosis and the unique complexities of early childhood, there are few programs designed to meet the needs of parents of young children at new onset. This study evaluated First STEPS (Study of Type 1 in Early childhood and Parenting Support), a stepped-care behavioral intervention designed to support parents' psychosocial functioning and promote children's glycemic outcomes. RESEARCH DESIGN AND METHODS: Using a two-site randomized clinical trial design, parents (n = 157) of children aged 1-6 years completed baseline data within 2 months of diabetes diagnosis and were randomly assigned to intervention (n = 115) or usual care (n = 42) for 9 months. Intervention steps included: 1) peer parent coaching, with step-ups to 2) structured behavioral counseling and 3) professional consultations with a diabetes educator and psychologist, based on parent mood and child HbA1c. Participants completed follow-ups at 9 and 15 months postrandomization. Primary outcomes were parent depressive symptoms and child HbA1c. RESULTS: Depressive symptoms improved in both groups, and intervention parents had significantly lower depressive symptoms at the 9- and 15-month follow-ups compared with usual care. HbA1c decreased in both groups, but there were no between-group differences at 9 or 15 months. CONCLUSIONS: First STEPS improved parents' mood following young children's type 1 diabetes diagnosis. Results indicate likely benefits of parent coach support, supplemented by intervention intensifications, including behavioral intervention and diabetes education. This model has high potential for patient engagement. The absence of a medical intervention component may explain null findings for HbA1c; incorporating targeted behavioral support for intensive diabetes treatment may maximize intervention impact.

Recruiting and retaining parents in behavioral intervention trials: Strategies to consider.

OBJECTIVE: Recruitment and retention are paramount to the success of randomized controlled trials (RCTs); however, strategies and challenges to optimize recruitment and retention are often omitted from outcomes papers. The current manuscript presents strategies used to recruit and retain over 97% parents of young children newly diagnosed with type 1 diabetes for over 15-months post-randomization enrolled in First STEPS, a behavioral, two-site RCT. METHOD: Participants included 157 primary caregivers of young children newly diagnosed with type 1 diabetes. Recruitment and retention strategies are described and include collaboration with medical teams, careful selection and training of study staff, inclusion of a behavioral run-in prior to randomization, financial incentives, creation of a study identity using retention items, obtainment of feedback from community stakeholders, and minimization of participant burden. RESULTS: Use of recruitment and retention strategies resulted in enrollment of 58% of eligible and reached families, with retention of the enrolled sample above 97% for over 15 months. Participants reported high acceptability of and satisfaction with specific recruitment and retention strategies. CONCLUSIONS: The strategies used to recruit and retain caregivers of young children newly diagnosed with a chronic illness were feasible to implement within multidisciplinary diabetes clinics and may apply to other pediatric populations. Future research may benefit from a focus on strategies to engage more diverse samples. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02527525.

Text Message Intervention for Teens with Type 1 Diabetes Preserves HbA1c: Results of a Randomized Controlled Trial.

Aims: Teens with type 1 diabetes (T1D) often struggle with diabetes self-management, which may lead to suboptimal self-care and worsening hemoglobin A1c (HbA1c). Innovative strategies are needed to improve self-care and protect against glycemic decline, especially during adolescence. We aimed to assess the impact on HbA1c of two interventions, problem-solving and text messaging, in teens with T1D. Methods: In a two-site randomized controlled trial, teens (N = 301) 13-17 years of age with T1D were randomized to one of the four groups using a 2 × 2 factorial design: Teenwork (TW), Text Messaging (Text), TW+Text, or Usual Care. TW intervention included problem-solving aimed at improving T1D self-care for blood glucose (BG) monitoring and insulin bolus dosing. Text intervention involved text reminders to check BG. The primary outcome was change in HbA1c from baseline to 12 months. Results: At baseline, teens (51% female, 78% white, 59% pump-treated) were (mean ± SD) 15.0 ± 1.3 years, had diabetes duration of 6.5 ± 3.7 years, and HbA1c 8.5% ± 1.1%. There was no significant difference in HbA1c over time by study group. Responsiveness to text reminders by teens in the TEXT and TW+TEXT predicted glycemic benefit; TW did not. Conclusions: Despite no HbA1c difference by study group, greater response to text message reminders to check BG led to better glycemic control and no deterioration in HbA1c; the problem-solving intervention did not. Given the high penetration of mobile phones and the wide acceptance of text messaging among teens in general, it is encouraging that a text messaging intervention can preserve HbA1c, thus preventing the expected deterioration in glycemic control often seen in teens with T1D.

Sources and Valence of Information Impacting Parents' Decisions to Use Diabetes Technologies in Young Children <8 Years Old with Type 1 Diabetes.

There are multiple information sources available to assist families in learning about rapidly advancing diabetes technologies as care options for their children. This study explored where and from whom families of young children with type 1 diabetes get information about diabetes technologies and the valence (positive vs. negative) of that information. Semi-structured interviews were conducted with parents (86% mothers) of 79 youth <8 years old with type 1 diabetes for ≥6 months, ([mean ± standard deviation] age 5.2 ± 1.5 years, diabetes duration 2.4 ± 1.3 years, 77% white, A1c 63 ± 10 mmol/mol [7.9 ± 0.9%], 66% pump-treated, 58% using continuous glucose monitors [CGMs]). Interviews were transcribed and underwent content analysis to derive central themes. Most parents reported learning about new technologies from three direct sources: diabetes care providers, people with diabetes, and caregivers of children with diabetes. Parents also cited three indirect sources of information: online forums, publications, and diabetes-specific conferences. Parents reported hearing primarily positive things about technologies. Families not using pump and/or CGM noted reluctance to use technology due to family-specific concerns (e.g., cost, child's unwillingness to wear device) rather than information from outside sources. In this subset of parents, many still expressed willingness to initiate use once family-specific concerns were resolved. Parents of young children received largely positive information about diabetes technologies, primarily from health care providers and others familiar with using devices personally or for their children. To maximize diabetes technology use in young children, it is incumbent upon providers to ensure families receive balanced realistic information about benefits and barriers.

Benefits and Barriers of Continuous Glucose Monitoring in Young Children with Type 1 Diabetes.

Background: Continuous glucose monitoring (CGM) has potential to address challenges of type 1 diabetes (T1D) management for young children. CGM use is increasing, yet remains underutilized. Characterizing parents' experiences with CGM can inform clinical strategies to help parents make decisions about diabetes management, overcome obstacles to initiating and sustaining CGM use, and maximize benefits of CGM use in their children's diabetes care. Methods: Transcripts from semistructured qualitative interviews with 55 parents of children aged 1 to <8 years, with T1D duration ≥6 months, and whose child currently or previously used CGM were coded and analyzed to derive themes about their experiences with CGM. Results: Participants were 88% mothers and the mean child age was 5.0 ± 1.5 years. Parents described benefits of CGM use: decreased worry about glucose excursions, improved sleep, increased sense of safety with children who cannot recognize or express symptoms of hypo- or hyperglycemia, and greater comfort with other caregivers, especially using remote monitoring functionality when away from children. Challenges included painful insertions, wearing multiple devices on small bodies, disruptive alerts, data gaps due to lost signals, skin/adhesive problems, and difficulty interpreting the amount of information generated by CGM. For some, the challenges outweighed potential benefits and they stopped CGM use. Conclusions: CGM may address unique challenges of T1D in young children and increase parental comfort with diabetes management, yet there are multiple barriers to initiating or maintaining CGM use. Education and behavioral support to address these benefits and barriers may equip caregivers with skills to address challenges of CGM use.