Remote intervention engagement and outcomes in the Clinical Trials in Organ Transplantation in Children consortium multisite trial.

Remote interventions are increasingly used in transplant medicine but have rarely been rigorously evaluated. We investigated a remote intervention targeting immunosuppressant management in pediatric lung transplant recipients. Patients were recruited from a larger multisite trial if they had a Medication Level Variability Index (MLVI) ≥2.0, indicating worrisome tacrolimus level fluctuation. The manualized intervention included three weekly phone calls and regular follow-up calls. A comparison group included patients who met enrollment criteria after the subprotocol ended. Outcomes were defined before the intent-to-treat analysis. Feasibility was defined as ≥50% of participants completing the weekly calls. MLVI was compared pre- and 180 days postenrollment and between intervention and comparison groups. Of 18 eligible patients, 15 enrolled. Seven additional patients served as the comparison. Seventy-five percent of participants completed ≥3 weekly calls; average time on protocol was 257.7 days. Average intervention group MLVI was significantly lower (indicating improved blood level stability) at 180 days postenrollment (2.9 ± 1.29) compared with pre-enrollment (4.6 ± 2.10), p = .02. At 180 days, MLVI decreased by 1.6 points in the intervention group but increased by 0.6 in the comparison group (p = .054). Participants successfully engaged in a long-term remote intervention, and their medication blood levels stabilized. NCT02266888.

Adolescent transplant recipients as peer mentors: a program to improve self-management and health-related quality of life.

The purpose of this study was to examine the safety, feasibility, acceptability, and preliminary efficacy of a cross-age peer mentoring program created to improve adherence and psychosocial outcomes for pediatric liver transplant recipients. Twenty-two participants were assigned to a "mentor now" or "mentor later" waitlist control group. Tacrolimus SD, a validated measure of adherence, was assessed for six months pre- and post-intervention for both groups. Self-report measures of self-management and HRQOL were completed at recruitment and three months after training. Participant report indicated the acceptability of the intervention. Clinically significant improvement in adherence was detected. No significant changes on the psychosocial outcome measures at follow-up were observed. This study demonstrated that an outpatient-based mentoring program is a safe, feasible, and acceptable option to incorporate within a pediatric liver transplant program with potential for promising application in other transplantation populations as well. These results also suggest that the program may have been associated with meaningful improvement in adherence, although further evaluation is warranted.

Psychosocial outcomes for children with nonalcoholic fatty liver disease over time and compared with obese controls.

OBJECTIVES: Children with nonalcoholic fatty liver disease (NAFLD) experience compromised quality of life (QOL) akin to those with other chronic disease. Our objectives were to examine the association between NAFLD and QOL as well as other psychosocial outcomes, to compare psychosocial outcomes to obese children without known NAFLD, and to determine whether present standard care for NAFLD results in weight loss and improvement in psychosocial outcomes longitudinally. METHODS: Children with NAFLD between 8 and 18 years and obese control children without known NAFLD were consented to complete a brief psychosocial battery examining depression (Children's Depression Inventory), QOL (Pediatric Quality of Life Inventory; PedsQL), and effect of weight on self-esteem (Body-Esteem Scale for Adolescents and Adults) at baseline; and additionally for the NAFLD group after at least 6 months. RESULTS: A total of 48 children with NAFLD and 40 obese control children were enrolled. The PedsQL scores were not significantly different but the CDI total score and subscales of negative mood, ineffectiveness, and negative self-esteem as well as all of the 3 subscales of BESAA, appearance, attribution, and weight were worse in the NAFLD group compared with obese controls. The PedsQL scores also did not change after standard care in the 33 patients with NAFLD who completed the follow-up evaluations, but the CDI score differed between those whose body mass index improved or not. CONCLUSIONS: Children with NAFLD have higher levels of depression than obese controls. Outcomes did not improve with standard care. Larger longitudinal studies and appropriate interventions are required in this area.

Changes in Saving Cognitions Mediate Hoarding Symptom Change in Cognitive-Behavioral Therapy for Hoarding Disorder.

Cognitive-behavioral therapy (CBT) is an empirically-supported treatment for hoarding disorder (HD). However, meta-analytic studies suggest that CBT is only modestly effective, and a significant number of individuals with HD remain symptomatic following treatment. To inform the development of more effective and targeted treatments, it will be important to clarify the mechanisms of treatment response in CBT for HD. To this end, the current study examined whether change in maladaptive saving beliefs mediated symptom change in CBT for HD. Sixty-two patients with primary HD completed measures of maladaptive saving cognitions and hoarding severity at pre-, mid-, and post-CBT. Results showed that change in saving cognitions mediated change in all three domains of HD symptoms (i.e., acquiring, difficulty discarding, and excessive clutter), suggesting that cognitive change may be a mechanism of treatment response in CBT. The findings indicate that cognitive change may have an impact on treatment outcomes, and are discussed in terms of cognitive-behavioral theory of HD and potential ways in which to enhance belief change in treatment.

Food-Allergic Adolescents at Risk for Anaphylaxis: A Randomized Controlled Study of Supervised Injection to Improve Comfort with Epinephrine Self-Injection.

BACKGROUND: Epinephrine self-injection is a key element in the management of food allergy, yet many adolescents report that they may not be able to use the autoinjector when needed. We hypothesized that supervised self-injection with an empty syringe would increase adolescents' comfort with self-injection. OBJECTIVE: The objective of this study was to examine the effect of supervised self-injection on self- and parent-reported comfort and anxiety during and after clinic visits in a food allergy center. METHODS: Sixty adolescent/parent pairs were randomized to self-injection versus control (education only). The predefined primary outcome was a self-reported comfort level with the injection before versus after the intervention on a Likert scale with scores of 1 (Not at all comfortable) to 10 (Extremely comfortable). The primary outcome was evaluated via within-group and between-group analyses. Secondary outcomes included adolescent and parent reports before versus after the injection, and changes in quality of life (QoL) and anxiety a month later. RESULTS: Self-injection was associated with a significant immediate increase in comfort levels (primary outcome; within-group comparison: mean scores: 6.93 preintervention vs 8.37 postintervention, P < .01; between-group ANOVA: 8.37 vs 6.69, P < .01) and with significant improvements in all other predefined (secondary) measures. On follow-up, QoL improved in 52% of intervention patients as compared with 25% of controls; similar differences were observed for anxiety. Those differences were not statistically significant. CONCLUSIONS: A self-injection (with an empty syringe) procedure in a clinic setting improves adolescents' and parents' comfort level with self-injecting. It may translate into substantial clinical benefits should self-injection be needed.

An assessment of the mental health care needs and utilization by families of children with a food allergy.

The present study aimed to examine whether caretakers of children with a food allergy experience distress and to determine their family's mental health-care needs and utilization. An anonymous survey was given to a sample of 454 caretakers during conferences hosted by the Food Allergy & Anaphylaxis Network. Overall, 32 percent of caretakers reported above threshold levels of distress while 70 percent stated that mental health support would have been helpful, but only 23 percent sought it. Even when mental health support was desired and available, few received it. Routine discussion of mental health needs with families receiving medical care may help address barriers to utilization.