Neurocognitive Outcomes from Memantine: A Pilot, Double-Blind, Placebo-Controlled Trial in Children with Autism Spectrum Disorder.

Objective: Studies interrogating therapeutics which alter the excitation-inhibition balance in the treatment of autism spectrum disorder (ASD) have reported mixed results on social and behavioral outcomes. Methods: The aim of this randomized, double-blind placebo-controlled pilot trial was to evaluate neurocognitive effects of memantine over a 24-week trial. Twenty-three children ages 6-12 years old with ASD were randomized to memantine or placebo. Primary outcomes included measures of apraxia and expressive language with evaluations at midpoint (week 12) and endpoint (week 24). Secondary outcomes included memory and adaptive behavior measures. Exploratory outcomes included changes in overall cognitive functioning and behavior (e.g., Aberrant Behavior Checklist). Results: Results suggest that memantine was well-tolerated. Dropout rates were high across groups with only 14 participants completing the 6-month trial. Memantine was not associated with improvements in apraxia and expressive language. Treatment with memantine was associated with improvements in verbal recognition memory as measured by the Narrative Memory-Recognition (NEPSY-II) (F = 5.05, p = .03). In addition, exploratory analyses of changes in Intelligence quotient (IQ) suggest improvements on verbal IQ (d = 1.8). Conclusions: Results suggest future studies of memantine in ASD may benefit from shifting treatment targets from social and behavioral outcomes to exploration of effects of memantine on cognition, potentially as an adjunct to learning and educational interventions. ClinicalTrials.gov: NCT01372449.

Engagement and Adherence With ezPARENT, an mHealth Parent-Training Program Promoting Child Well-Being.

Mobile health (mHealth) interventions use mobile technology (tablets and smartphones) delivery platforms for interventions to improve health outcomes. Despite growing acceptance, there is little understanding of how consumers engage with and adhere to mHealth interventions. This study analyzes usage data from the intervention arm ( n = 42) of a randomized clinical trial testing the efficacy of the ezPARENT program and provides recommendations for using engagement and adherence metrics. Engagement was measured by parent usage (duration, frequency, and activity) of ezPARENT and adherence using an adherence index (the sum of individual modules completed, number of visits to ezPARENT, and maximum time between visits). Parents spent M = 37.15 min per module and had M = 13.55 program visits in the 3-month intervention period. Parents visited the program over a period of M = 69.5 days and completed 82% of the modules. These data provide support that parents will use intervention programs delivered digitally; engagement and adherence metrics are useful in evaluating program uptake.

Bilingual Text4Walking Food Service Employee Intervention Pilot Study.

BACKGROUND: Half of all adults in the United States do not meet the level of recommended aerobic physical activity. Physical activity interventions are now being conducted in the workplace. Accessible technology, in the form of widespread usage of cell phones and text messaging, is available for promoting physical activity. OBJECTIVE: The purposes of this study, which was conducted in the workplace, were to determine (1) the feasibility of implementing a bilingual 12-week Text4Walking intervention and (2) the effect of the Text4Walking intervention on change in physical activity and health status in a food service employee population. METHODS: Before conducting the study reported here, the Text4Walking research team developed a database of motivational physical activity text messages in English. Because Hispanic or Latino adults compose one-quarter of all adults employed in the food service industry, the Text4Walking team translated the physical activity text messages into Spanish. This pilot study was guided by the Physical Activity Health Promotion Framework and used a 1-group 12-week pre- and posttest design with food service employees who self-reported as being sedentary. The aim of the study was to increase the number of daily steps over the baseline by 3000 steps. Three physical activity text messages were delivered weekly. In addition, participants received 3 motivational calls during the study. RESULTS: SPSS version 19.0 and R 3.0 were used to perform the data analysis. There were 33 employees who participated in the study (57.6% female), with a mean age of 43.7 years (SD 8.4). The study included 11 Hispanic or Latino participants, 8 of whom requested that the study be delivered in Spanish. There was a 100% retention rate in the study. At baseline, the participants walked 102 (SD 138) minutes/day (per self-report). This rate increased significantly (P=.008) to 182 (SD 219) minutes/day over the course of the study. The participants had a baseline mean of 10,416 (SD 5097) steps, which also increased significantly (P=.017) to 12,540 (SD 5149). They significantly improved their performance on their aerobic fitness test (P<.001). The participants had a baseline mean systolic blood pressure of 120 mm Hg and diastolic blood pressure of 76 mm Hg, a mean body mass index of 29.29 kg/m2, and a mean waist circumference of 36.95 inches, without significant changes seen at 12 weeks. CONCLUSIONS: We were able to conduct a motivational physical activity text messaging intervention within the workplace setting. Both physical activity and aerobic fitness improved. However, at baseline, participants were more active than they perceived themselves to be. Although there is insufficient evidence to draw strong conclusions about the study findings, it would be useful to test this physical activity text messaging intervention in a sedentary sample within a larger workplace intervention study trial conducted over a longer time frame.

Parent Use and Efficacy of a Self-Administered, Tablet-Based Parent Training Intervention: A Randomized Controlled Trial.

BACKGROUND: Parent training programs are traditionally delivered in face-to-face formats and require trained facilitators and weekly parent attendance. Implementing face-to-face sessions is challenging in busy primary care settings and many barriers exist for parents to attend these sessions. Tablet-based delivery of parent training offers an alternative to face-to-face delivery to make parent training programs easier to deliver in primary care settings and more convenient and accessible to parents. We adapted the group-based Chicago Parent Program (CPP) to be delivered as a self-administered, tablet-based program called the ezParent program. OBJECTIVE: The purpose of this study was to (1) assess the feasibility of the ezParent program by examining parent satisfaction with the program and the percent of modules completed, (2) test the efficacy of the ezParent program by examining the effects compared with a control condition for improving parenting and child behavior in a sample of low-income ethnic minority parents of young children recruited from a primary care setting, and (3) compare program completion and efficacy with prior studies of the group-based CPP. METHODS: The study used a two-group randomized controlled trial (RCT) design with repeated measures follow up. Subjects (n=79) were randomly assigned to an intervention or attention control condition. Data collection was at baseline and 12 and 24 weeks post baseline. Parents were recruited from a large, urban, primary care pediatric clinic. ezParent module completion was calculated as the percentage of the six modules completed by the intervention group parents. Attendance in the group-based CPP was calculated as the percentage of attendance at sessions 1 through 10. Satisfaction data were summarized using item frequencies. Parent and child data were analyzed using a repeated measures analysis of variance (RM-ANOVA) with simple contrasts to determine if there were significant intervention effects on the outcome measures. Effect sizes for between group comparisons were calculated for all outcome variables and compared with CPP group based archival data. RESULTS: ezParent module completion rate was 85.4% (34.2/40; 95% confidence interval [CI] = 78.4%-93.7%) and was significantly greater (P<.05) than face-to-face CPP group attendance (135.2/267, 50.6%) attendance of sessions; 95% CI = 46.8%-55.6%). ezParent participants reported the program as very helpful (35/40, 88.0%) and they would highly recommend the program (33/40, 82.1%) to another parent. ezParent participants showed greater improvements in parenting warmth (F1,77 = 4.82, P<.05) from time 1 to 3. No other significant differences were found. Cohen's d effect sizes for intervention group improvements in parenting warmth, use of corporal punishment, follow through, parenting stress, and intensity of child behavior problems were comparable or greater than those of the group-based CPP. CONCLUSIONS: Data from this study indicate the feasibility and acceptability of the ezParent program in a low-income, ethnic minority population of parents and comparable effect sizes with face-to-face delivery for parents.

Bilingual Text Messaging Translation: Translating Text Messages From English Into Spanish for the Text4Walking Program.

BACKGROUND: Hispanic adults in the United States are at particular risk for diabetes and inadequate blood pressure control. Physical activity improves these health problems; however Hispanic adults also have a low rate of recommended aerobic physical activity. To address improving physical inactivity, one area of rapidly growing technology that can be utilized is text messaging (short message service, SMS). A physical activity research team, Text4Walking, had previously developed an initial database of motivational physical activity text messages in English that could be used for physical activity text messaging interventions. However, the team needed to translate these existing English physical activity text messages into Spanish in order to have culturally meaningful and useful text messages for those adults within the Hispanic population who would prefer to receive text messages in Spanish. OBJECTIVE: The aim of this study was to translate a database of English motivational physical activity messages into Spanish and review these text messages with a group of Spanish speaking adults to inform the use of these text messages in an intervention study. METHODS: The consent form and study documents, including the existing English physical activity text messages, were translated from English into Spanish, and received translation certification as well as Institutional Review Board approval. The translated text messages were placed into PowerPoint, accompanied by a set of culturally appropriate photos depicting barriers to walking, as well as walking scenarios. At the focus group, eligibility criteria for this study included being an adult between 30 to 65 years old who spoke Spanish as their primary language. After a general group introduction, participants were placed into smaller groups of two or three. Each small group was asked to review a segment of the translated text messages for accuracy and meaningfulness. After the break out, the group was brought back together to review the text messages. RESULTS: A translation confirmation group met at a church site in an urban community with a large population of Hispanics. Spanish speaking adults (N=8), with a mean age of 40 (SD 6.3), participated in the study. Participants were engaged in the group and viewed the text messages as culturally appropriate. They also thought that text messages could motivate them to walk more. Twenty-two new text messages were added to the original database of 246 translated text messages. While the text messages were generally understood, specific word preferences were seen related to personal preference, dialect, and level of formality which resulted in minor revisions to four text messages. CONCLUSIONS: The English text messages were successfully translated into Spanish by a bilingual research staff and reviewed by Hispanic participants in order to inform the use of these text messages for future intervention studies. These Spanish text messages were recently used in a Text4Walking intervention study.