Strengthening Families Program Online

NCT04214327 | Unknown DMC

• 1 other identifier: StrengtheningFamilies
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Substance Abuse

Outcome Measures

Primary Outcomes (4)

• Change in family cohesion as assessed using the Moos Family Environment Scale

  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.

  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

• Change in parents' setting clear, firm rules against youth substance use as assessed using the Kumpfer Strengthening Families Program (SFP) Skills Instrument

  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

  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

• Change in parental supervision of children as assessed using the Kumpfer Strengthening Families Program (SFP) Skills instrument.

  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.

  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

• Change in youth attitude favorable to alcohol use over time as assessed using the Bach Harrison Prevention Needs Assessment (PNA) Instrument

  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.

  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

Study Arms (4)

Strengthening Families Program Online eLearning Game

ACTIVE COMPARATOR

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.

Behavioral: Strengthening Families Program Online eLearning Game

SFP Home-use DVD/video series

ACTIVE COMPARATOR

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.

Behavioral: SFP Home-use DVD

Wait-Listed Control

ACTIVE COMPARATOR

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.

Behavioral: Strengthening Families Program Online eLearning Game; Behavioral: Wait-Listed Control

SFP Group Norms

NO INTERVENTION

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.

Interventions

Strengthening Families Program Online eLearning Game BEHAVIORAL

Families (parent/caregiver and children) are to play-test a highly interactive online gamified version of the Strengthening Families Program called SFP Online, with 10 lessons that utilize three 10-minute mini-sessions and games that teach parents evidence-based parenting and family relationship skills and teach youth social, life, and alcohol and drug refusal skills. Skills are reinforced through gaming. Game points are achieved by right answers to self-correcting mini-quizzes for low-stakes failure and through actual reported home practice of the skills. The SFP parenting skills have been shown to reduce risk factors and increase protective factors that prevent youth substance abuse.

Strengthening Families Program Online eLearning Game; Wait-Listed Control

SFP Home-use DVD BEHAVIORAL

Family views an 11-session SFP video series online or at home using a DVD that contains the same program and lesson content as the online condition; however, the lesson material is more static without the interaction required in the gamified version of SFP Online.

SFP Home-use DVD/video series

Wait-Listed Control BEHAVIORAL

Families receive no active intervention for 22 weeks; however, during this wait time, participants receive weekly email reminders that contain riddles and puzzles for youth and parents receive nutritional information and food preparation recipes. Following conclusion of the initial trial the wait-listed control sites are then administered the 10-session SFP Online intervention

Wait-Listed Control

Eligibility Criteria

• Age: 11 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Strengthening Families Program LLC: lead

Study Sites (1)

Strengthening Families Program LLC

Salt Lake City, Utah, 84103, United States

Location

Related Publications (45)

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MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• Karol L Kumpfer, PhD

  Strengthening Families Program LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study design involves a three-condition parallel randomized control trial contrasting: (1) SFP Online Game, (2) SFP Home-use DVD/video series, and (3) Wait-Listed Controls. (4) We will use a non-inferiority trial (NIT) to empirically examine the efficacy of SFP Online when compared to the SFP Group Norms data. The Group Norms data is a representative, demographically matched sample of n=1400 families drawn from a database of over 6,000 families that have attended the full 14-session traditional group class format of SFP.

Study Record Dates

• First Submitted: December 20, 2019
• First Posted: January 2, 2020
• Study Start: December 15, 2022
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: January 6, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: When study and evaluation are completed estimated August 2022
• Access Criteria: Find link on company website

Locations

US (1)