Cost analysis of a randomized trial of Getting to Outcomes implementation support for a teen pregnancy prevention program offered in Boys and Girls Clubs in Alabama and Georgia

Prevention Science - Implementation support can improve outcomes of evidence-based programs (EBP) for adolescents, but with a cost. To assist in determining whether this cost is worthwhile, this...     

Outcomes of a Cluster Randomized Controlled Trial of the SoMe Social Media Literacy Program for Improving Body Image-Related Outcomes in Adolescent Boys and Girls

Although the negative effect of social media use among youth on body image and eating concerns has been established, few classroom-based resources that can decrease these effects through targeting social media literacy skills have been developed. This study aimed to test the efficacy of SoMe, a social media literacy body image, dieting, and wellbeing program for adolescents, through a cluster randomized controlled trial. Participants (n = 892; M_age = 12.77, SD = 0.74; range 11–15; 49.5% male) were randomized by school (n = 8) to receive either weekly SoMe (n = 483) or control sessions (lessons as usual; n = 409) over 4 weeks in their classroom. Participants completed surveys at four timepoints (baseline, 1-week post-intervention, and 6- and 12-month follow-up) assessing body dissatisfaction, dietary restraint, strategies to increase muscles (primary outcomes), self-esteem and depressive symptoms (secondary outcomes), and internalization of appearance ideals and appearance comparison (exploratory outcomes). Modest positive intervention effects were found in dietary restraint and depressive symptoms at 6-month follow-up in girls but few positive effects emerged for boys. The findings provide only preliminary support for a social media literacy intervention, but suggest the usefulness of both identifying those who benefit most from a universally delivered intervention and the need to refine the intervention to maximize intervention effects.     

Development and Implementation of an Interactive Text Messaging Campaign to Support Behavior Change in a Childhood Obesity Randomized Controlled Trial

Text messaging is a promising means of intervening on an array of health issues among varied populations, but little has been published about the development of such interventions. The authors describe the development and implementation of an interactive text messaging campaign for parents to support behavior change among children in a childhood obesity randomized controlled trial. The authors invited 160 parents to participate in a text messaging intervention that provided behavior change support in conjunction with health coaching phone calls and mailed materials on behavioral goals. Throughout the 1-year intervention, the authors sent 1–2 text messages per week. The first asked how the child did with a target behavior the day before; parents who replied received an immediate feedback message tailored to their response. The second included a tip about how to work toward a behavioral goal. Baseline surveys indicate that text messaging is a common means of communication for parents, and many are willing to use text messaging to support behavior change for their child. Results at 1 year indicate a high level of engagement with the text messaging intervention, with nearly two thirds responding to 75% or more of the questions they were sent by text.     

Reducing Sexual Risk Behavior in Adolescent Girls: Results From a Randomized Controlled Trial

PurposeTeenage girls in low-income urban settings are at an elevated risk for HIV, sexually transmitted infections, and unintended pregnancies. The purpose of this study was to evaluate the efficacy of a sexual risk-reduction (SRR) intervention, supplemented with postintervention booster sessions, targeting low-income, urban, sexually active teenage girls.MethodRandomized controlled trial in which sexually active urban adolescent girls (n = 738) recruited in a midsize northeastern U.S. city were randomized to a theory-based SRR intervention or to a structurally equivalent health promotion control group. Assessments and behavioral data were collected using audio computer-assisted self-interview at baseline, then at 3, 6, and 12 months postintervention. Both interventions included four small-group sessions and two booster sessions.ResultsRelative to girls in the control group, girls receiving the SRR intervention were more likely to be sexually abstinent; if sexually active, they showed decreases in (a) total episodes of vaginal sex at all follow-ups, (b) number of unprotected vaginal sex acts at 3 and 12 months, and (c) total number of sex partners at 6 months. Medical record audits for girls recruited from a clinical setting (n = 322) documented a 50% reduction in positive pregnancy tests at 12 months.ConclusionsTheory-based behavioral interventions tailored to adolescent girls can help to reduce sexual risk and may also reduce unintended pregnancies. Although sexually active at enrollment, many of the girls receiving the intervention were more likely to practice secondary abstinence. Continued refinement of SRR interventions for girls is needed to ensure they are feasible, appealing, and effective.     

Outcomes of Residential Treatment: A Study of the Adolescent Clients of Girls and Boys Town

Pre-treatment and post-treatment data was collected from adolescent clients of a new residential treatment center at Girls and Boys Town. Youth who received treatment improved significantly on the Child Behavior Checklist and the Children's Global Assessment Scale and were maintaining their treatment gains at follow-up. Ten months following discharge, the majority were stabilized and functioning adequately in school and with their primary caregiver. For these youth, residential treatment succeeded where other interventions failed.     

Educational Outcomes for Orphan Girls in Rural Zimbabwe: Effects of a School Support Intervention

Educational achievement has important implications for the health and well-being of young women in sub-Saharan Africa. The authors assessed the effects of providing school support on educational outcomes of orphan girls in rural Zimbabwe. Data were from a randomized controlled trial offering the intervention group comprehensive schooling support and controls no treatment initially and then fees only. Results indicated comprehensive support reduced school dropout and absence but did not improve test scores. Providing support to orphan girls is promising for addressing World Health Organization Millennium Development Goals, but further research is needed about contextual factors affecting girls’ school participation and learning.     

Outcomes of a Randomized Trial of a Cognitive Behavioral Enhancement to Address Maternal Distress in Home Visited Mothers

Objectives To assess the effectiveness of a 6-week, cognitive behavioral therapy (CBT) group-based enhancement to home visiting to address stress and prevent depression as compared with home visiting as usual in low income mothers of young children. Methods We conducted a randomized controlled trial with 95 low-income mothers of young children to assess the effectiveness of a 6-week, cognitive behavioral group-based enhancement to Healthy Families America and Parents as Teachers home visiting (HV/CBT = 49) to address stress and prevent depression as compared with home visiting as usual (HV = 46). Booster sessions for the HV/CBT group were offered at 3 and 6 months. Participants completed measures of coping, stress and depression at three points: baseline prior to randomization, post-intervention, and 6 months post-intervention. Parent child interaction was also measured at 6 months. Results Intent-to-treat analyses found improved coping and reduced stress and depression post-intervention. While impacts on these outcomes were attenuated at 6 months, positive impacts were observed for selected aspects of mothers’ interactions with their children. Maternal characteristics at baseline were associated with participation in the intervention and with post-intervention and 6-month outcomes. Mothers with lower levels of stress and those with fewer children were more likely to attend intervention sessions. Mothers with lower levels of stress had more favorable post intervention outcomes. Conclusions CBT group-based enhancement to home visiting improved maternal coping, reduced stress and depression immediately post intervention but not at 6 months, suggesting more work is needed to sustain positive gains in low-income mothers of young children.     

Sustaining an Evidence-Based Program Over Time: Moderators of Sustainability and the Role of the Getting to Outcomes® Implementation Support Intervention

Problematic rates of alcohol, e-cigarette, and other drug use among US adolescents highlight the need for effective implementation of evidence-based programs (EBPs), yet schools and community organizations have great difficulty implementing and sustaining EBPs. Although a growing number of studies show that implementation support interventions can improve EBP implementation, the literature on how to improve sustainability through implementation support is limited. This randomized controlled trial advances the literature by testing the effects of one such implementation intervention—Getting To Outcomes (GTO)—on sustainability of CHOICE, an after-school EBP for preventing substance use among middle-school students. CHOICE implementation was tracked for 2 years after GTO support ended across 29 Boys and Girls Club sites in the greater Los Angeles area. Predictors of sustainability were identified for a set of key tasks targeted by the GTO approach (e.g., goal setting, evaluation, collectively called “GTO performance”) and for CHOICE fidelity using a series of path models. One year after GTO support ended, we found no differences between GTO and control sites on CHOICE fidelity. GTO performance was also similar between groups; however, GTO sites were superior in conducting evaluation. Better GTO performance predicted better CHOICE fidelity. Two years after GTO support ended, GTO sites were significantly more likely to sustain CHOICE implementation when compared with control sites. This study suggests that using an implementation support intervention like GTO can help low-resource settings continue to sustain their EBP implementation to help them get the most out of their investment. ClinicalTrials.gov Identifier: NCT02135991.

     

Six-Month Outcomes from a Randomized Controlled Trial to Prevent Perinatal Depression in Low-Income Home Visiting Clients

Perinatal depression (PD) has negative consequences for mothers and children and is more prevalent among women of low socioeconomic status. Home visitation programs serve low-income pregnant women at risk for PD. This study tested the efficacy of a group-based cognitive behavioral intervention (Mothers and Babies Course; MB) in reducing depressive symptoms and preventing the onset of perinatal depression among low-income women enrolled in home visitation. A randomized controlled trial was conducted. Seventy-eight women who were pregnant or had a child less than 6 months of age and who were assessed as at risk for PD were randomized to the MB intervention or usual home visiting services. Depressive symptoms were assessed at baseline and 1-week, 3- and 6-months post-intervention; depressive episodes were assessed with a clinical interview at the 6-month follow-up. Depressive symptoms declined at a significantly greater rate for intervention participants than usual care participants between baseline and 1-week, 3 and 6 months post-intervention. At the 6-month follow-up, 15 % of women who received the MB intervention had experienced a major depressive episode as compared with 32 % of women receiving usual care. Integrating mental health interventions into home visitation appears to be a promising approach for preventing PD. Cognitive behavioral techniques can be effective in preventing depression in perinatal populations and treating it.     

Dietary Outcomes in a Spanish-Language Randomized Controlled Diabetes Prevention Trial With Pregnant Latinas

Objectives. We evaluated the effectiveness of a community-based healthy lifestyle intervention in improving dietary behaviors of pregnant Latinas from 2004 to 2006 in Detroit, Michigan.Methods. The 11-week, culturally tailored, Spanish-language Healthy Mothers on the Move (MOMs) intervention offered home visits, group classes, related activities, and social support from trained community health workers (CHWs) and peers. Dietary behaviors were measured by food frequency questionnaire. Linear mixed models estimated pre- and post-intervention changes, within and between MOMs intervention and minimal intervention (MI) groups.Results. MOMs (n = 139) and MI (n = 139) participants had similar baseline characteristics and dietary intake. Post-intervention, MOMs participants showed significant improvement in all dietary behaviors, except fruit and fiber consumption. Compared with MI participants, MOMs participants had significantly decreased consumption of added sugar (P = .05), total fat (P < .05), saturated fat (P < .01), percentage of daily calories from saturated fat (P < .001), solid fats and added sugars (P < .001), and had increased vegetable consumption (P < .001). Their increase in fiber consumption (P < .05) was significant relative to MI participants’ decrease in fiber intake.Conclusions. We confirmed the hypothesis that a community-planned, CHW-led healthy lifestyle intervention could improve dietary behaviors of low-income Latina women during pregnancy.Obesity, gestational diabetes, and type 2 diabetes are prevalent among Latina women of childbearing age in the United States.1–6 Dietary intake, particularly low consumption of vegetables and fruits and high consumption of added sugars and solid fats, is associated with these conditions.7–13 In the Diabetes Prevention Program randomized controlled trial, an intensive healthy lifestyle intervention that helped participants develop healthy diet and exercise patterns reduced the risk of developing type 2 diabetes among nonpregnant women with impaired glucose tolerance by half, including those with and without a history of gestational diabetes.14Pregnancy may be an optimum period for interventions to improve dietary behaviors10,15,16 that have consequences for both maternal and child health.11,17–20 Following the success of the Diabetes Prevention Program, it is important to assess whether community-based healthy lifestyle interventions can reduce diabetes risk factors in pregnant women.18 Nonetheless, few randomized controlled studies have included dietary outcomes for pregnant women.21,22 Only 1 pilot study was conducted in pregnant Latinas.23To address this gap, a community-academic partnership used community-based participatory research (CBPR) processes to develop and implement Healthy Mothers on the Move (MOMs), a community health worker (CHW)-led healthy lifestyle intervention tailored to the needs and strengths of pregnant Latinas in Detroit, Michigan.24–26 Healthy MOMs aimed to demonstrate the effectiveness of this intervention to reduce behavioral and clinical risk factors for type 2 diabetes in pregnant and postpartum Latinas. We examined the hypothesis that women randomly assigned to the MOMs intervention group would significantly decrease their intake of added sugars, total fat and saturated fat, and significantly increase their intake of fruit, vegetables and fiber, compared with women assigned to the minimal intervention (MI) control group during pregnancy.     

Randomized Controlled Trial of Back School With and Without Peer Support

The aim of this trial was to determine whether social interaction between patients with long-lasting nonspecific back pain reduces subjective or objective disability. The participants were selected from persons visiting an occupational health care unit because of back pain. After a clinical examination in a university clinic, subjects without a specific diagnosis and having no disabilities preventing active rehabilitation were selected for study. The subjects (n = 108) were randomized into treatment (n = 54) and control groups (n = 54). Altogether 18 study groups, 9 treatment groups and 9 groups for controls, were formed. Before starting the back schools altogether 15 subjects dropped out. Both the treatment groups (n = 47) and the controls (n = 46) attended a back school consisting of 10 lessons and demonstrations supervised by a physiotherapist. The participants in treatment groups, but not the controls, had physical exercise and social intercourse with other members within the group. The clinical examination was repeated after 6 and 12 months. Both the treatment groups and the controls showed improvement in perceived functional capacity (assessed with Oswestry disability questionnaire) and in perceived life quality (assessed with 15D score). At the 6-month follow-up life quality had improved statistically significantly more among the participants in treatment groups than among the controls, and at the 12-month follow-up the Oswestry index showed corresponding improvement. Among subjects suffering from nonspecific back pain, social support improves the results of active rehabilitation.     

Four-Year Follow-Up of a Randomized Controlled Trial of Triple P Group for Parent and Child Outcomes

Approximately 15–20 % of children experience behavioral and/or emotional difficulties. Evidence-based treatment will likely not be sufficient to reduce the prevalence of these difficulties in children and adolescents. Effective prevention programs are therefore also needed to enable families access to support at multiple points across the lifecourse. The aim of the current investigation was to evaluate the 4-year efficacy of the group-based Triple P (Positive Parenting Program) as a prevention program administered universally. Seventeen preschools were randomly assigned to Triple P (n?=?11 preschools, 186 families) or a no parenting intervention control group (n?=?6 preschools, 94 families). Long-term efficacy was analyzed with hierarchical linear models using maternal and paternal self-report measures. Mothers and fathers from the intervention preschool group reported significant reductions in dysfunctional parenting behavior (d?=?0.24 and 0.19, respectively). Mothers also reported a less steep decline from pre- to post-intervention in positive parenting behavior, which was maintained 4 years later (d?=?0.38). Fathers from intervention preschools reported a delayed less steep decline in positive parenting during the follow-up (d?=?0.33). In addition, mothers from intervention preschools reported immediate improvement in child behavior problems during the program while mothers from control preschools did not report this immediate change. However, with mothers from intervention preschools reporting more child behavior problems at baseline, the effect disappeared by the fourth year (d?=?0.19). The results support the long-term efficacy of the Triple P-group program as a universal prevention intervention for changing parenting behavior while there was little evidence for maintenance of change in behavior problems.     

Employment Outcomes in a Randomized Trial of Second-Generation Antipsychotics and Perphenazine in the Treatment of Individuals with Schizophrenia

Employment has been increasingly recognized as an important goal for individuals with schizophrenia. Previous research has shown mixed results on the relationship of specific antipsychotic medications to employment outcomes, with some studies finding greater benefits for second-generation antipsychotic medications (SGAs) over first-generation antipsychotic medication (FGAs). A randomized controlled trial (CATIE) examined medication assignment and both employment outcomes and participation in psychosocial rehabilitation (PSR) among 1,121 individuals with a diagnosis of schizophrenia randomized to SGAs (olanzapine, quetiapine, risperidone, ziprasidone) or one FGA (perphenazine). Service use and employment were assessed at quarterly interviews. There were no differences between medication groups on employment outcomes or participation in PSR. Consistent with other CATIE results, there were no differences in employment or participation in PSR among these five medications, including the FGA perphenazine.     

No Improvements in Postnatal Dietary Outcomes Were Observed in a Two-Arm,Randomized, Controlled,Comparative Impact Trial among Rural,Southern, African-American Women

Background

Suboptimal diet quality, prevalent among postpartum women, is troubling for mothers and their children because positive relationships between maternal and child diet quality exist.

Spiritually Based Intervention to Increase Colorectal Cancer Awareness Among African Americans: Intermediate Outcomes From a Randomized Trial

Colorectal cancer screening, while effective for reducing mortality, remains underutilized particularly among underserved populations such as African Americans. The present study evaluated a spiritually based approach to increasing Health Belief Model–based pre-screening outcomes in a Community Health Advisor–led intervention conducted in African American churches. Sixteen urban churches were randomized to receive either the spiritually based intervention or a nonspiritual comparison of the same structure and core colorectal cancer content. Trained Community Health Advisors led a series of two educational sessions on colorectal cancer early detection. The educational sessions were delivered over a 1-month period. Participants (N = 316) completed a baseline survey at enrollment and a follow-up survey one month after the first session. Both interventions resulted in significant pre/post increases in knowledge, perceived benefits of screening, and decreases in perceived barriers to screening. Among women, the spiritually based intervention resulted in significantly greater increases in perceived benefits of screening relative to the nonspiritual comparison. This finding was marginal in the sample as a whole. In addition, perceived benefits to screening were associated with behavioral intention for screening. It is concluded that in this population, the spiritually based was generally as effective as the nonspiritual (secular) communication.     

Intervening with Practitioners to Improve the Quality of Prevention: One-Year Findings from a Randomized Trial of Assets-Getting To Outcomes

There continues to be a gap in prevention outcomes achieved in research trials versus those achieved in “real-world” practice. This article reports interim findings from a randomized controlled trial evaluating Assets-Getting To Outcomes (AGTO), a two-year intervention designed to build prevention practitioners’ capacity to implement positive youth development–oriented practices in 12 community coalitions in Maine. A survey of coalition members was used to assess change on individual practitioners’ prevention capacity between baseline and one year later. Structured interviews with 32 program directors (16 in the intervention group and 16 in the control group) were used to assess changes in programs’ prevention practices during the same time period. Change in prevention capacity over time did not differ significantly between the intervention and control groups. However, in secondary analyses of only those assigned to the AGTO intervention, users showed greater improvement in their self-efficacy to conduct Assets–based programming and increases in the frequency with which they engaged in AGTO behaviors, whereas among non-users, self-efficacy to conduct Assets–based programming declined. Interview ratings showed improvement in several key areas of performance among intervention programs. Improvement was associated with the number of technical assistance hours received. These results suggest that, after one year, AGTO is beginning to improve the capacity of community practitioners who make use of it.     

多重填补在随机干预试验研究中的应用

目的 利用多重填补方法实现对含缺失值的随机干预试验进行分析.方法 结合心理干预试验研究数据,利用SAS程序PROC MI和PROC MIANALYZE实现缺失数据的填补,应用稳健协方差分析评价心理健康干预效果.结果 填补与未填补分析结果一致,心理健康指标在干预组和对照组差别均无统计学意义,但CBO结局与干预有交互作用.结论 干预对学生心理健康起到一定的作用,但差别无统计学意义.     

Preventing Alcohol Use with a Voluntary After-School Program for Middle School Students: Results from a Cluster Randomized Controlled Trial of CHOICE

There are many mandated school-based programs to prevent adolescent alcohol and drug (AOD) use, but few are voluntary and take place outside of class time. This cluster randomized controlled trial evaluates CHOICE, a voluntary after-school program for younger adolescents, which reduced both individual- and school-level alcohol use in a previous pilot study. We evaluated CHOICE with 9,528 students from 16 middle schools. The sample was 51% female; 54% Hispanic, 17% Asian, 15% white, 9% multiethnic and 3% African American. Fifteen percent of students attended CHOICE. All students completed surveys on alcohol beliefs and use at baseline and 6-7?months later. We conducted intention-to-treat (ITT) school-level analyses and propensity-matched attender analyses. Lifetime alcohol use in the ITT analysis (i.e., school level) achieved statistical significance, with an odds ratio (OR) of 0.70 and a NNT of 14.8. The NNT suggests that in a school where CHOICE was offered, 1 adolescent out of 15 was prevented from initiating alcohol use during this time period. Although not statistically significant (p?=?.20), results indicate that past month alcohol use was also lower in CHOICE schools (OR = 0.81; NNT = 45). Comparisons of attenders versus matched controls yielded results for lifetime use similar to school-wide effects (OR = 0.74 and NNT = 17.6). Initial results are promising and suggest that a voluntary after-school program that focuses specifically on AOD may be effective in deterring alcohol use among early adolescents; however, further research is needed as program effects were modest.