Strengthening Families Program Online

NCT04214327 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 480

Last updated 2023-01-06

No results posted yet for this study

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

Interventions

BEHAVIORAL

Strengthening Families Program Online eLearning Game

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.

BEHAVIORAL

SFP Home-use DVD

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.

BEHAVIORAL

Wait-Listed Control

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

Sponsors & Collaborators

  • Strengthening Families Program LLC

    lead INDUSTRY

Principal Investigators

  • Karol L Kumpfer, PhD · Strengthening Families Program LLC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
11 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-12-15
Primary Completion
2023-09-30
Completion
2023-09-30

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04214327 on ClinicalTrials.gov