Efficacy of mindfulness-based stress reduction in emerging adults with poorly controlled, type 1 diabetes: A pilot randomized controlled trial.

BACKGROUND/OBJECTIVE: The negative effects of stress on persons with type 1 diabetes (T1D) are well-established, but effective interventions to reduce stress among emerging adults with T1D are limited. The study objective was to conduct a pilot randomized controlled trial (RCT) to obtain preliminary data on the efficacy of mindfulness-based stress reduction (MBSR) to reduce stress and improve diabetes health outcomes in a population of high-risk, urban emerging adults with poorly controlled diabetes. METHODS: Forty-eight participants aged 16 to 20 years of age with T1D (mean duration = 8 years) were randomly assigned to one of three conditions: MSBR, cognitive-behavioral stress management (CBSM), or a diabetes support group. Data were collected at baseline, end of treatment, and 3 months after treatment completion. Measures of self-reported stress and depressive symptoms, diabetes management, and glycemic control were obtained. RESULTS: MBSR was found to reduce self-reported stress at end of treatment (P = 0.03, d = -0.49) and 3-month follow-up (P = 0.01, d = -0.67), but no effects on diabetes management or glycemic control were found. Diabetes support group participants had improved glycemic control at the end of treatment (P = 0.01, d = -0.62) as well as reduced depressive symptoms at 3-month follow-up (P = 0.01, d = -0.71). CONCLUSIONS: Results provide preliminary support for the efficacy of MBSR to improve psychosocial adjustment in emerging adults with poorly controlled T1D but require replication in adequately powered studies. Findings also support the value of peer support in improving health outcomes in this age group.

A Multi-Site Study of Social Cognitive Factors Related to Adherence Among Youth Living With HIV in the New Era of Antiretroviral Medication.

Objective: The goal of the current study was to determine how a set of social cognitive factors predict antiretroviral therapy (ART) medication adherence in youth living with HIV in an era of newer highly active ART medications using a conceptual model. Methods: Behaviorally infected youth living with HIV ages 13-24 (N = 822) from 14 sites within the Adolescent Medicine Trials Unit (AMTU) were included in the study. Structural equation modeling was used to explore predictors of ART medication adherence. Results: Results found that motivational readiness for ART was related to higher ART medication adherence, which was associated with lower viral load. Higher social support and higher self-efficacy had an indirect relationship with higher adherence through increased motivational readiness. Fewer psychological symptoms were associated with higher social support and higher self-efficacy. Lower substance use was directly associated with lower adherence. Conclusions: The results provide insight into factors that may be related to adherence in youth living with HIV. Findings suggest focusing on motivational readiness to increase adherence. Improving the patients' ART self-efficacy and strengthening their social support networks during treatment can increase motivational readiness for ART treatment. Furthermore, programs maybe more effective with the inclusion of risk reduction components especially those related to substance use.

Adaptation of an Evidence-Based Diabetes Management Intervention for Delivery in Community Settings: Findings From a Pilot Randomized Effectiveness Trial.

Objective: To adapt an evidence-based intervention targeting diabetes management in adolescents with poorly controlled type 1 diabetes for use in a community setting by community health workers (CHWs) and to conduct pilot testing of the new intervention, REACH for Control (RFC). The study was conducted as a collaboration between university researchers and a federally qualified health center. Methods In a pilot effectiveness trial, feasibility and acceptability of RFC were evaluated based on participant enrollment, treatment dose, and consumer satisfaction. RFC effects on adolescent adherence, health outcomes, and quality of life were also assessed. The trial used a parallel group design. Families were randomized to 6 months of RFC plus standard medical care (n = 26) or standard care (SC) only (n = 24). Data were collected at baseline and 7-month posttest. A mixed-methods approach was used to analyze data. Results: Qualitative analyses suggested that caregivers viewed RFC and delivery of a home-based intervention by CHWs positively. Furthermore, adolescents who received RFC had statistically significant (p = .05) and clinically meaningful improvements in hemoglobin A1c (HbA1c) (0.7%) and reported significant improvements in quality of life from baseline to follow-up (p = .001). No significant changes were found for adolescents in standard medical care. However, while dose of primary intervention session delivered was acceptable, dose of follow-up sessions used for skills practice was low. Conclusions: Results provide preliminary support for RFC's acceptability and effectiveness to improve health status and quality of life when used in community settings serving high-risk, low-income families. Additional testing in a full-scale effectiveness trial appears warranted.

Calendaring and alarms can improve naturalistic time-based prospective memory for youth infected with HIV.

Individuals with HIV disease often evidence deficits in prospective memory (PM), which interfere with daily functioning and increase the risk of suboptimal health behaviours. This study examined the benefits of simple encoding and cueing supports on naturalistic time-based PM in 47 HIV-positive young adults. All participants completed a naturalistic time-based PM task in which they were instructed to text the examiner once per day for seven days at a specified time. Participants were randomised into (1) a Calendaring condition in which they created a calendar event in their mobile telephone for the specified texting time; (2) an Alarm condition in which they programmed an alarm into their mobile telephone for the specified texting time; (3) a Combined calendaring and alarm condition; and (4) a Control condition. Participants in the Combined condition demonstrated significantly better naturalistic PM performance than participants in the Control and Calendaring conditions. Findings indicate that HIV-positive young people may benefit from a combined calendaring and alarm supportive strategy for successful execution of future intentions in daily life.

Visualisation of future task performance improves naturalistic prospective memory for some younger adults living with HIV disease.

Human immunodeficiency virus (HIV) disease is commonly associated with deficits in prospective memory (PM), which increase the risk of suboptimal health behaviours, like medication non-adherence. This study examined the potential benefits of a brief future visualisation exercise during the encoding stage of a naturalistic PM task in 60 young adults (aged 19-24 years) with HIV disease. Participants were administered a brief clinical neuropsychological assessment, which included a standardised performance-based measure of time- and event-based PM. All participants were also given a naturalistic PM task in which they were asked to complete a mock medication management task when the examiner showed them the Grooved Pegboard Test during their neuropsychological evaluation. Participants were randomised into: (1) a visualisation condition in which they spent 30 sec imagining successfully completing the naturalistic PM task; or (2) a control condition in which they repeated the task instructions. Logistic regression analyses revealed significant interactions between clinical neurocognitive functions and visualisation. HIV positive (HIV+) participants with intact retrospective learning and/or low time-based PM demonstrated observable gains from the visualisation technique, while HIV+ participants with impaired learning and/or intact time-based PM did not evidence gains. Findings indicate that individual differences in neurocognitive ability moderate the response to visualisation in HIV+ young adults. The extent to which such cognitive supports improve health-related PM outcomes (e.g., medication adherence) remains to be determined.

Brief Computer-Delivered Intervention to Increase Parental Monitoring in Families of African American Adolescents with Type 1 Diabetes: A Randomized Controlled Trial.

BACKGROUND: African American adolescents with type 1 diabetes (T1D) are at elevated risk for poor diabetes management and metabolic control. Parental supervision and monitoring of adolescent diabetes management have been shown to promote better diabetes management among adolescents, but parents typically decrease their oversight during the transition to independent diabetes care. INTRODUCTION: The purpose of the study was to conduct a randomized clinical trial to test the feasibility and efficacy of a three-session, computer-delivered motivational intervention (The 3Ms) to promote increased parental monitoring among primary caregivers of young African American adolescents with T1D. The intervention was brief and optimized for delivery during routine diabetes clinic visits. MATERIALS AND METHODS: Sixty-seven adolescents with T1D aged 11-14 and their primary caregiver were randomly assigned to one of three arms: adolescent and parent motivational intervention (Arm 1), adolescent control and parent motivational intervention (Arm 2), or adolescent and parent control (Arm 3). Intervention effects were assessed 1 month after intervention completion. RESULTS: Parents in Arm 1 and Arm 2 had significant increases in knowledge of the importance of monitoring adolescents' diabetes care. Parents in Arm 2 also had trend to significant increases in direct observation and monitoring of adolescent diabetes care, and adolescents in Arm 2 had significant improvements in glycemic control. DISCUSSION AND CONCLUSIONS: Findings from the present study provide preliminary support for the efficacy of a brief, computer-delivered parenting intervention for improving family management practices and adolescent health outcomes among African American adolescents with T1D and their caregivers.

Mediators of Treatment Effects in a Randomized Clinical Trial of Multisystemic Therapy-Health Care in Adolescents With Poorly Controlled Asthma: Disease Knowledge and Device Use Skills.

OBJECTIVE: Determine whether Multisystemic Therapy-Health Care (MST-HC) improved asthma knowledge and controller device use skills among African-American youth with poorly controlled asthma and whether any improvements mediated changes in illness management. METHODS: A randomized controlled trial was conducted with 170 adolescents with moderate to severe asthma. Families were randomized to MST-HC or attention control. Data were collected at baseline and 6 and 12 months after intervention completion. RESULTS: In linear mixed models, adolescents in the MST-HC group had increases in asthma knowledge; asthma knowledge was unchanged for attention control. Controller device use skills increased for adolescents in the MST-HC group, while skills declined for attention control. Both knowledge and skills mediated the relationship between intervention condition and changes in illness management. CONCLUSIONS: Tailored, home-based interventions that include knowledge and skills building components are one means by which illness management in African-American youth with poorly controlled asthma can be improved.

Sequential Multiple Assignment Randomized Trial (SMART) to Construct Weight Loss Interventions for African American Adolescents.

The purpose of this study was to develop an adaptive behavioral treatment for African American adolescents with obesity. In a sequential multiple assignment randomized trial, 181 youth ages 12-16 years with primary obesity and their caregiver were first randomized to 3 months of home-based versus office-based delivery of motivational interviewing plus skills building. After 3 months, nonresponders to first phase treatment were rerandomized to continued home-based skills or contingency management. Primary outcome was percent overweight and hypothesized moderators were adolescent executive functioning and depression. There were no significant differences in primary outcome between home-based or office-based delivery or between continued home-based skills or contingency management for nonresponders to first-phase treatment. However, families receiving home-based treatment initially attended significantly more sessions in both phases of the trial, and families receiving contingency management attended more sessions in the second phase. Overall, participants demonstrated decreases in percent overweight over the course of the trial (3%), and adolescent executive functioning moderated this effect such that those with higher functioning lost more weight. More potent behavioral treatments to address the obesity epidemic are necessary, targeting new areas such as executive functioning. Delivering treatment in the home with contingency management may increase session attendance for this population.

Correlation between use of antiretroviral adherence devices by HIV-infected youth and plasma HIV RNA and self-reported adherence.

Our objective was to investigate antiretroviral adherence device use by HIV-infected youth and assess associations of device use with viral suppression and self-reported adherence. This cross-sectional, multisite, clinic-based study included data from 1,317 HIV-infected individuals 12-24 years of age that were prescribed antiretroviral therapy. Mean adherence in the past 7 days was 86.1 % and 50.5 % had an undetectable HIV RNA. Pillbox was the most commonly endorsed device. No specific device was independently associated with higher odds of 100 % adherence. Paradoxically, having an undetectable HIV RNA was inversely associated with use of adherence devices (OR 0.80; p = 0.04); however, among those with <100 % adherence, higher adherence was associated with use of one or more adherence devices (coefficient = 7.32; p = 0.003). Our data suggest that adolescents who experienced virologic failure often used adherence devices which may not have been sufficiently effective in optimizing adherence. Therefore, other tailored adherence-enhancing methods need to be considered to maximize virologic suppression and decrease drug resistance and HIV transmission.

Motivational interviewing targeting risky sex in HIV-positive young Thai men who have sex with men.

Motivational interviewing (MI) has been shown to reduce sexual risks among HIV-positive men who have sex with men (HMSM) in the US. We conducted a randomized trial of Healthy Choices, a 4-session MI intervention, targeting sexual risks among 110 HIV-positive youth ages 16-25 years in Thailand. Risk assessments were conducted at baseline, 1 month, and 6 months post-intervention. This report presents the analysis of 74 HMSM in the study. There were 37 HMSM in the Intervention group and 37 in the control group. The proportions of participants having anal sex and having sex with either HIV-uninfected or unknown partners in past 30 days were significantly lower in Intervention group than in Control group at 6 months post-intervention (38 vs. 65 %, p = .04; and 27 vs. 62 %, p < .01, respectively). There were no significant differences in general mental health scores and HIV stigma scores between the two groups at any study visit. Thirty-five (95 %) HMSM in the Intervention group vs. 31 (84 %) in control group attended ≥ 3 sessions. Loss to follow-up was 8 and 30 %, respectively (p = .04). Healthy Choices for young Thai HMSM was associated with sexual risk reduction. Improvements in mental health were noted in Intervention group. Healthy Choices is a promising behavioral intervention and should be further developed to serve the needs of young HMSM in resource-limited countries.

Recruitment strategies and the retention of obese urban racial/ethnic minority adolescents in clinical trials: the FIT families project, Michigan, 2010-2014.

INTRODUCTION: The successful recruitment and retention of participants is integral to the translation of research findings. We examined the recruitment and retention rates of racial/ethnic minority adolescents at a center involved in the National Institutes of Health Obesity Research for Behavioral Intervention Trials (ORBIT) initiative by the 3 recruitment strategies used: clinic, informatics, and community. METHODS: During the 9-month study, 186 family dyads, each composed of an obese African American adolescent and a caregiver, enrolled in a 6-month weight-loss intervention, a sequential multiple assignment randomized trial. We compared recruitment and retention rates by recruitment strategy and examined whether recruitment strategy was related to dyad baseline characteristics. RESULTS: Of the 186 enrolled families, 110 (59.1%) were recruited through clinics, 53 (28.5%) through informatics, and 23 (12.4%) through community. Of those recruited through community, 40.4% enrolled in the study, compared with 32.7% through clinics and 8.2% through informatics. Active refusal rate was 3%. Of the 1,036 families identified for the study, 402 passively refused to participate: 290 (45.1%) identified through informatics, 17 (29.8%) through community, and 95 (28.3%) through clinics. Recruitment strategy was not related to the age of the adolescent, adolescent comorbidities, body mass index of the adolescent or caregiver, income or education of the caregiver, or retention rates at 3 months, 7 months, or 9 months. Study retention rate was 87.8%. CONCLUSION: Using multiple recruitment strategies is beneficial when working with racial/ethnic minority adolescents, and each strategy can yield good retention. Research affiliated with health care systems would benefit from the continued specification, refinement, and dissemination of these strategies.

Task importance affects event-based prospective memory performance in adults with HIV-associated neurocognitive disorders and HIV-infected young adults with problematic substance use.

Two experiments were conducted to examine the effects of task importance on event-based prospective memory (PM) in separate samples of adults with HIV-associated neurocognitive disorders (HAND) and HIV-infected young adults with substance use disorders (SUD). All participants completed three conditions of an ongoing lexical decision task: (1) without PM task requirements; (2) with PM task requirements that emphasized the importance of the ongoing task; and (3) with PM task requirements that emphasized the importance of the PM task. In both experiments, all HIV+ groups showed the expected increase in response costs to the ongoing task when the PM task's importance was emphasized. In Experiment 1, individuals with HAND showed significantly lower PM accuracy as compared to HIV+ subjects without HAND when the importance of the ongoing task was emphasized, but improved significantly and no longer differed from HIV+ subjects without HAND when the PM task was emphasized. A similar pattern of findings emerged in Experiment 2, whereby HIV+ young adults with SUD (especially cannabis) showed significant improvements in PM accuracy when the PM task was emphasized. Findings suggest that both HAND and SUD may increase the amount of cognitive attentional resources that need to be allocated to support PM performance in persons living with HIV infection.

The use of cell phone support for non-adherent HIV-infected youth and young adults: an initial randomized and controlled intervention trial.

This randomized behavioral trial examined whether youth living with HIV (YLH) receiving cell-phone support with study funded phone plans, demonstrated improved adherence and viral control during the 24 week intervention and 24 weeks post-intervention compared to controls. Monday through Friday phone calls confirmed medications were taken, provided problem-solving support, and referred to services to address adherence barriers. Of 37 participants (ages 15-24), 62 % were male and 70 % were African American. Self-reported adherence was significantly higher in the intervention group compared to the control at 24 and 48 weeks for the past month (P = 0.007) and log 10 HIV VL was significantly lower at both 24 weeks (2.82 versus 4.52 P = 0.002) and 48 weeks (3.23 versus 4.23 P = 0.043). Adherence and viral load showed medium to large effect sizes across the 48 week study. This is the first study to demonstrate sustained clinically significant reductions in HIV VL using youth friendly technology.

The initial feasibility of a computer-based motivational intervention for adherence for youth newly recommended to start antiretroviral treatment.

Young people represent the largest number of new HIV infections, thus youth living with HIV (YLH) are likely to be the largest group to initiate antiretroviral treatment (ART). Adherence patterns for behaviorally infected YLH are not adequate to effectively manage the disease; therefore, novel interventions are needed to improve medication adherence. The purpose of the current study, which will precede a randomized controlled trial, was to assess the initial feasibility of an individually tailored computer-based two-session interactive motivational interviewing (MI) intervention for YLH newly recommended to start ART. Intervention development occurred in collaboration with three youth advisory groups. Ten youth (ages 18-24) were recruited to participate in this study. Participants completed the intervention online. Intervention components focused on medication adherence (rating perceived importance and confidence, and goal setting). Retention was 100% for both intervention sessions. All participants (n=10) felt medication adherence was important, but 80% felt confident they could manage their adherence to HIV medications. Ninety percent of participants set the goal of taking their HIV medications exactly as prescribed and reported success achieving this goal at follow-up. Additionally, participants were satisfied with the quality of the sessions and the amount of assistance they received for managing their adherence to HIV medications (90% participants for Session 1; 89% for Session 2). Per exit interview responses, participants felt that the intervention made them think more about their health and was a motivator for them to take better care of their health. In conclusion, the intervention was feasible for YLH enrolled in the study.

Barriers to medication adherence in behaviorally and perinatally infected youth living with HIV.

The study explored barriers to antiretroviral medication adherence in perinatally and behaviorally HIV infected adolescents and young adults in a cross-sectional, multisite sample. The study included a subset of a convenience sample from a cross-sectional analysis. Participants were youth with HIV ages 12-24 who were prescribed HIV medication and reported missing medication in the past 7 days (n = 484, 28.4 % of protocol sample). The top barriers were similar for perinatally and behaviorally infected youth, but perinatally infected youth reported significantly more barriers. Forgetting, not feeling like taking medication and not wanting to be reminded of HIV infection were the most common barriers reported. Number of barriers was significantly correlated with percent of doses missed, viral load, and psychological distress for perinatally infected youth and with doses missed, psychological distress, and substance use for behaviorally infected youth. Interventions to improve adherence to HIV medications should not only address forgetfulness and choosing not to take medications, but also consider route of infection.

Motivational interviewing targeting risk behaviors for youth living with HIV in Thailand.

Healthy Choices, a four-session motivational interviewing-based intervention, reduces risk behaviors among US youth living with HIV (YLWH). We randomized 110 Thai YLWH (16-25 years) to receive either Healthy Choices or time-matched health education (Control) over 12 weeks. Risk behaviors were assessed at baseline, 1, and 6 months post-session. The pilot study was not powered for between-group differences; there were no statistical differences in sexual risks, alcohol use, and antiretroviral adherence between the two groups at any visit. In within-group analyses, Healthy Choices group demonstrated decreases in the proportion of HIV-negative partners (20 vs 8.2%, P = 0.03) and HIV sexual risk scores (4.3 vs 3.3, P = 0.04), and increased trends in the proportion of protected sex (57 vs 76.3%, P = 0.07) from baseline to 1 month post-session. These changes were not sustained 6 months later. No changes were observed in Control group. Healthy Choices has potential to improve sexual risks among Thai YLWH.

Multisystemic therapy for poorly adherent youth with HIV: results from a pilot randomized controlled trial.

Adherence to antiretroviral medication for the treatment of HIV is a significant predictor of virologic suppression and is associated with dramatic reductions in mortality and morbidity and other improved clinical outcomes for pediatric patient populations. Effective strategies for addressing adherence problems in youth infected with HIV are needed and require significant attention to the complex interplay of multiple, interacting causal risk factors that lead to poor self-care. Within the context of a pilot randomized trial, we evaluated the feasibility and initial efficacy of a multisystemic therapy (MST) intervention adapted to address HIV medication adherence problems against a usual care condition that was bolstered with a single session of motivational interviewing (MI). For 34 participating youth, health outcomes (viral load [VL] and CD4 count) were obtained from approximately 10 months pre-baseline through approximately 6 months post-baseline and self-reported medication adherence outcomes were obtained quarterly from baseline through 9 months post-baseline. Using mixed-effects regression models we examined within- and between-groups differences in the slopes of these outcomes. Feasibility was supported, with a 77% recruitment rate and near-maximal treatment and research retention and completion rates. Initial efficacy also was supported, with the MST condition but not the MI condition demonstrating statistically and clinically significant VL reductions following the start of treatment. There was also some support for improved CD4 count and self-reported medication adherence for the MST but not the MI condition. MST was successfully adapted to improve the health outcomes of youth poorly adherent to antiretroviral medications. Replication trials and studies designed to identify the mechanisms of action are important next steps.

Asthma medication device skills in high-risk African American adolescents.

OBJECTIVE: To describe the asthma medication device skills of high-risk African American adolescents and associations between skills and other components of illness management, METHODS: 170 African American adolescents, with at least one hospitalization or two emergency department visits in the last year, demonstrated how they use their asthma quick-relief and controller medication devices. Observations were scored using an in vivo observation asthma skills checklist. To assess other areas of asthma management, adolescents and their primary caregiver were interviewed using the Family Asthma Management System Scales, RESULTS: Only 5% of adolescents correctly demonstrated all controller skills, and none of the adolescents correctly showed all quick-relief inhaler skills (5% showed between 90 and 95% of skills). Several components of asthma management predicting controller medication skills were attendance at an asthma specialty clinic, collaboration with provider, medication adherence, and quick-relief medication skills. These variables accounted for a total of 24% of the variance in controller medication skills, CONCLUSIONS: Results indicate the need for interventions directly targeting observed asthma management skills and the importance of relationship with providers.

Motivational Enhancement System for Adherence (MESA): pilot randomized trial of a brief computer-delivered prevention intervention for youth initiating antiretroviral treatment.

OBJECTIVE: To pilot test a two-session computer-delivered motivational intervention to facilitate adherence among youth with HIV newly prescribed antiretroviral treatment (ART). METHODS: Youth (N = 76) newly prescribed ART were recruited from 8 sites, and were randomized to the intervention or an active nutrition and physical activity control. Primary outcomes were HIV-1 viral load at baseline, 3 months, and 6 months, and self-reported adherence at 3 and 6 months. RESULTS: Satisfaction ratings were high. Effect sizes suggested that the intervention group showed a greater drop than controls in viral load from baseline to 6 months (Cohen's d = 0.39 at 3 months; d = 0.19 at 6 months), and had greater percent undetectable by 6 months (d = 0.28). Effects sizes were medium to large for 7-day and weekend adherence. CONCLUSIONS: A brief computer-delivered motivational intervention showed promise for youth starting ART and is ready to be tested in a full-scale clinical trial.

Social ecological predictors of longitudinal HIV treatment adherence in youth with perinatally acquired HIV.

OBJECTIVE: To apply a social ecological model to explore the psychosocial factors prospectively associated with longitudinal adherence to antiretroviral treatment in youth perinatally infected with HIV. METHODS: Randomly selected youth, age 8 to <19 years old, completed cognitive testing and psychosocial questionnaires at baseline as part of a multisite protocol (N = 138). A validated caregiver-report measure of adherence was completed at baseline and 24 and 48 weeks after baseline. RESULTS: In multivariate analysis, youth awareness of HIV status, caregiver not fully responsible for medications, low caregiver well-being, adolescent perceptions of poor caregiver-youth relations, caregiver perceptions of low social support, and African American ethnicity were associated with nonadherence over 48 weeks. CONCLUSIONS: Interventions focusing on caregivers and their interactions with the individual youth and extrafamilial system should be prioritized for prevention and treatment efforts to address nonadherence during the transition into adolescents.