Strengthening Families Program Online for Teens and Families
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 480
- 试验地点
- 1
- 主要终点
- Change in family cohesion as assessed using the Moos Family Environment Scale
研究概览
简要总结
This Phase II SBIR tests a newly developed web-based online parenting skills training and youth drug prevention program based on the evidenced-based "Strengthening Families Program." The study design involves a three-condition parallel randomized control trial contrasting: (1) SFP Online, (2) SFP Home-use DVD/videos, and (3) Wait-Listed Controls.
DELIVERY OF INTERVENTION: The intervention condition, SFP Online, is a highly interactive, multimedia condition testing a 10-session online program with two intersecting tracks, one for parents and one for youth. Both tracks involve completion of three mini-lessons per week delivered online for 10 weeks. For the parent track (biological parents, caregivers or legal guardians), each lesson entails learning nurturing parenting skills that strengthen family bonds, setting clear boundaries with positive discipline, and monitoring youth's social activities and emotional well-being. The youth lessons teach social competence-based skills and drug refusal skills. For both tracks, lesson material is scaffolded in an integrated fashion, with challenge quizzes and process evaluations interspersed throughout the lessons. Each track includes a gaming portion to increase engagement and reinforce lesson content through stealth learning. The SFP Home-use DVD/video series is an 11-session program with the same content as the online version, but is not interactive. It is viewed either online or using a DVD player at home. In the Wait-Listed control condition, parents receive emails with food recipes and nutritional information over the same 10-week period; while their children receive emails with riddles and puzzles. At the conclusion of a 2-month follow-up period the wait-listed controls receive the SFP Online intervention, thus doubling the size of the intervention treatment condition. A second design feature is the use of a non-inferiority trial (NIT) to empirically examine the efficacy of SFP Online when compared to the Home-use DVD/videos and Group Norms data. The Group Norms, which serve as a benchmark of SFP effectiveness, is a representative, demographically matched sample of n=1400 families drawn from a database of over 6,000 families that have taken the full 14-session traditional class format of SFP. Effects sizes, using the partial eta-squared statistic, will be compared between conditions for the major outcome measures.
详细描述
This study tests a new web-based online parenting skills training and youth drug prevention program based on the evidence-based Strengthening Families Program. The study design involves a three-condition parallel randomized control trial contrasting: (1) SFP Online, (2) SFP Home-use DVD/videos, and (3) Wait-Listed Controls. The intervention condition, SFP Online, is an interactive, multimedia condition testing a 10-session online program with interrelated tracks for parents and youth. Both tracks involve completion of three mini-lessons per week delivered online for 10 weeks. Each track includes a gaming portion to increase engagement and reinforce lesson content through stealth learning. The SFP Home-use DVD/video series is an 11-session program with the same content as the online version, but is delivered via an online video presentation or a DVD player. The Wait-Listed control condition receives emails with recipes over the same 10-week period; their youth receive riddles. At the conclusion of a 10-week waiting period, the wait-listed controls receive the SFP Online intervention. Our statistical analysis addresses the differences between the online and Home-use DVD/video conditions.
A second design feature is a Non-Inferiority Trial (NIT) to empirically examine the efficacy of SFP Online when compared to the SFP Group Norms data. The Group Norms, which serves as a benchmark of SFP effectiveness, is a representative, demographically matched sample of n=1400 families drawn from a database of 6,000 families who have attended the full SFP 14-session classes. Effects sizes, using the partial eta-squared statistic, will be compared between conditions for the major outcome measures. The effect sizes will be adjusted for demographics differences at the individual level as well as implementation factors. The margin of equivalence for the effect size comparison between conditions is set at 10% (the effect sizes for the SFP Online program outcomes will be at least 10% larger than the corresponding effect sizes for the SFP videos or Group Norms).
RECRUITMENT: The investigators will recruit 240 families with at least one parent/caregiver and youth (n=480 participants), with 80 families randomly assigned to each experimental condition. Recruitment is handled by 24 SFP recruiters who sent Letters of Support. They are ethnically diverse and geographically dispersed across the U.S. They have access to multiple races/ethnicities and marginalized families. Each recruiter is targeting recruitment of 10 families (24 recruiters x 10 families).
ASSIGNMENT: Individual families will be randomly assigned to one of three interventions with a computerized random number generator to eliminate selection bias and control unobserved confounding variables that contribute to program outcomes. We will examine the distribution of relevant demographic variables (race/ethnicity, income, education, adult and child age) to assure balance between conditions at baseline. We conduct analyses to detect significant program differences in intervention effects by these variables.
STATISTICAL ANALYSIS: Prior to evaluating program effects, we examine pretest equivalence between experimental conditions using appropriate tests for categorical or continuous baseline measures. Significant differences are controlled in covariate-adjusted models evaluating program efficacy. This analysis uses a 3 (condition) x 2 (baseline risk) ANOVA with continued presence in the study as the dependent variable. We also examine whether there is any differential attrition by condition (i.e., coding attrition as 1/0 and using logistic regression models to predict retention). We also use confirmatory techniques to contrast variance/ covariance matrixes between conditions to assess whether patterns of statistical relations differ by condition. Differential attrition by condition could potentially limit internal validity (intervention effects might be confounded with attrition effects) or external validity (generalizability to other families). Data analyses begins by generating simple descriptive statistics on all baseline measures (e.g., frequencies, means, variance), repeating this procedure for the posttest and the 2-month follow-up data. Distributions are examined for skewness and kurtosis and response patterns. Chi-square tests, point bi-serial and Pearson correlations are used to examine Statistical relations between baseline predictors (i.e., checking for multicollinearity), demographics, and outcome variables will be assessed using appropriate measures of association and evaluated for statistical significance using chi-square, t, and F tests). Violating assumptions of normality and homoscedasticity (often encountered in family research and when assessing youth self-report drug use) will require data transformations (e.g., logarithmic, arcsine, spline, or percentile weighting). If the transformations fail to normalize the data, we can use nonparametric tests (e.g., Kendall's Tau, Mann-Whitney U-test, Wilcoxon Rank Sum, Spearman's correlation, and Freidman's ANOVA). For non-Gaussian distributions that arise from low frequency behaviors we can employ Poisson regression, zero-inflated, and two-part semicontinuous models to adjust for highly skewed distributions with a preponderance of zeroes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 11 Years 至 —(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Computer access
- •Internet access
- •Child between 11 and 17
- •Adult and child must have functional email
- •Only one child per family will be included unless the household has twins, in which case both children can participate
- •Adult (parent or legal guardian) provides informed consent and gives permission for child to participate
- •Child assents to participate
排除标准
- •Intellectual disabilities (i.e., cognitive impairment that prohibits use of the computer)
- •Language difficulties (must read and understand spoken English)
- •Not having children that meet the intervention age criteria (11-17)
- •Not having an electronically signed consent/permission form - adult
- •Not having an electronically signed assent form - youth
研究组 & 干预措施
Strengthening Families Program Online eLearning Game
This arm of the study receives a 10-session online family-based intervention with separate, but intersecting, tracks for parents and youth. Each lesson contains 3 mini-lessons per week and includes behavioral skills training and interactive multimedia lessons with video vignettes that target parenting skills, family cohesion, organization, communication, social skills, and drug prevention for youth. The youth track is highly gamified to stimulate engagement and reinforce the core active ingredients. There are self-correcting quizzes to assess learning, and process evaluation to determine program fidelity and engagement. There are learning theory instructional design elements with scaffolding, stealth learning, and theoretical principles of social learning, social interactional, and family systems theory. There is a highly animated game families can play upon successful completion of each lesson, using game points they earned through quizzes and practices. There is a 3-month follow-up.
干预措施: Strengthening Families Program Online eLearning Game (Behavioral)
SFP Home-use DVD/video series
This arm of the study receives an 11-session home-use DVD or coupon code for viewing the SFP videos online at home that contains the same SFP skills and lesson content as the online condition. However, the lesson material is not animated and involves simply viewing the videos at home. This arm represents an "attention-control" condition as the requirements of participation and exposure to the intervention will match the online condition, as participants use the Internet or a DVD player to view lesson material in a self-paced format. There are no differences in recruitment for this condition; all assignment to experimental conditions is based on their recruiter's location using a randomized control trial design. Participants in this condition will be provided a hyperlink URL to answer pre- and posttest assessments and at the 3-month follow-up. Process evaluation materials will be delivered via a hyperlink to a commercial survey vendor during the trial and at the conclusion.
干预措施: SFP Home-use DVD (Behavioral)
Wait-Listed Control
This arm of the study receives no active intervention for the initial intervention period of 11 weeks; however, following conclusion of the initial trial the wait-listed control sites are then administered the 10-session SFP Online intervention. During the initial trial of 11 weeks, participants in this condition receive weekly email reminders that contain riddles and puzzles for youth and parents receive nutritional information and food preparation recipes. The intent of these weekly emails is to stimulate continued participation and reduce attrition.
Individual families will be randomly assigned to one of the three interventions with a computerized random number generator.
干预措施: Strengthening Families Program Online eLearning Game (Behavioral)
Wait-Listed Control
This arm of the study receives no active intervention for the initial intervention period of 11 weeks; however, following conclusion of the initial trial the wait-listed control sites are then administered the 10-session SFP Online intervention. During the initial trial of 11 weeks, participants in this condition receive weekly email reminders that contain riddles and puzzles for youth and parents receive nutritional information and food preparation recipes. The intent of these weekly emails is to stimulate continued participation and reduce attrition.
Individual families will be randomly assigned to one of the three interventions with a computerized random number generator.
干预措施: Wait-Listed Control (Behavioral)
SFP Group Norms
This arm of the study provides a means to conduct a non-inferiority trial contrasting the active intervention conditions (SFP Online and Home-use DVD/videos) to the traditional 14-session in-person group-delivery format, which serves as a benchmark of effectiveness for SFP. There is no data collection as the Group Norms are part of an existing database of families that already took SFP classes. All effect size comparisons are conducted using secondary data analysis. The expected margin of equivalence is set at 10% so that any condition that exceeds another in the magnitude of effect size is considered as 'good as' the comparison condition. All effect sizes will be adjusted for demographic and site-specific factors to control for clustering and within-site contextual factors that can influence program outcomes.
结局指标
主要结局
Change in family cohesion as assessed using the Moos Family Environment Scale
时间窗: The investigators will assess all participants at baseline, again 10-weeks later at posttest following delivery of the intervention, and again at 22 weeks post-baseline for follow-up
The investigators will assess family cohesion over time using the Moos Family Environment Scale. An example of a questions is: "I praise my child when he/she behaves well" (alpha=.79). Responses are on a 5-point scale: "1=Never;" "2=Rarely;" "3=Sometimes;" "4=Often;" "5=Almost Always;" with five (5) being the highest value.
Change in parental supervision of children as assessed using the Kumpfer Strengthening Families Program (SFP) Skills instrument.
时间窗: The investigators will assess all participants at baseline, again 10-weeks later at posttest following delivery of the intervention, and again at 22 weeks post-baseline for follow-up
The investigators will assess parental supervision of their children over time using the Kumpfer Strengthening Families Program (SFP) Skills instrument. An example is: "I know where my child is and who he/she is with"; alpha=.70). Responses are on a 5-point scale: "1=Never;" "2=Almost never;" "3=Sometimes;" "4=Often;" "5=Almost Always" with 5 being the highest value.
Change in youth attitude favorable to alcohol use over time as assessed using the Bach Harrison Prevention Needs Assessment (PNA) Instrument
时间窗: The investigators will assess all participants at baseline, again 10-weeks later at posttest following delivery of the intervention, and again at 22 weeks post-baseline for follow-up
The investigators will assess change in youth attitude favorable to alcohol use using questions from the Bach Harrison Prevention Needs Assessment (PNA) a nationally representative epidemiological survey targeting youth that is used in 14 states. An example of a question is: "How wrong do you think it is for someone your age to drink beer, wine or hard liquor (vodka, whiskey, or gin) at least once or twice a month?" Responses are on a 5 point scale: "1=Not wrong at all;" "2= a little bit wrong;" "3=Sometimes wrong;" "4=Wrong;" "5=Very Wrong;" with 5 being the highest value.
Change in parents' setting clear, firm rules against youth substance use as assessed using the Kumpfer Strengthening Families Program (SFP) Skills Instrument
时间窗: The investigators will assess all participants at baseline, again 10-weeks later at posttest following delivery of the intervention, and again at 22 weeks post-baseline for follow-up
The investigators will assess change in parents' setting clear, firm rules against youth substance use over time using the Kumpfer SFP Skills instrument. An example is: "Our family has set clear rules about no youth alcohol or drug use"; alpha=.79). Responses are on a 5-point scale: "1=Never;" "2=Almost never;" "3=Sometimes;" "4=Often; "5=Almost Always" with 5 being the highest value
次要结局
未报告次要终点
