Prevention of Substance Use in At-Risk Students: A Family-Centered Web Program

NCT03060291 | Completed Results

• 1 other identifier: R01DA037628
• Study Type: interventional
• Target: 322
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to develop and evaluate the effectiveness of a web-based version of the Family Check-up (FCU). The FCU is a school-based family-centered intervention that has been developed over the past 20 years and tested across the United States with diverse populations. It focuses on enhancing parenting skills and family management in early adolescence. The FCU has been shown to be highly effective at reducing adolescent problem behavior, achievement problems, depression, and substance use over an extended period of time. In the original FCU, parents complete an assessment that evaluates family strengths and challenges. They then receive feedback from a family consultant about how their data compare to other families with children of the same age. As part of this feedback session, the consultant helps motivate parents to make changes at home that will positively impact their child and family overall. Parents and consultants decide together which child behaviors they most want to see change. The consultant then works with parents to enhance relevant parenting and family management skills. Despite the demonstrated effectiveness of this intervention, few schools have the resources and staffing to implement it without substantial support. It seems, then, that schools would benefit from an online package that requires fewer school resources to implement. The FCU-Online is designed to incorporate the successful components of the original FCU while reducing the burden on schools. And, because it is accessed online, parents can utilize this resource at a time and location convenient to them. In this study, 300 families will be randomly assigned to one of three conditions: a web/ mobile-only version of the FCU, a web/mobile + coach version, or middle school as usual. Research on mental health interventions delivered over the internet suggests that a coach or "in-person" contact enhances outcomes. However, programs that require no coaching or in-person contact are cheaper and easier for schools to deliver. Therefore, a web/ mobile-only version may allow more schools to deliver the intervention to a greater number of families and children. Thus, investigators will test the relative effectiveness of a coach version versus an online-only version at improving key parenting skills. It is predicted that changes in parenting will lead to reductions in risk behavior, such as problem behavior at school and substance use.

Conditions

Substance Use; Conduct Disorders in Adolescence; Depression; Anxiety

Keywords

Family Check-up

Outcome Measures

Primary Outcomes (7)

• Change From Baseline in Youth Effortful Control Across 12 Months (Parent Report)

  Parents reported on their child's effortful attention control via questionnaire using an 8-item subscale of the Early Adolescent Temperament Questionnaire- Revised. Parents were asked to use a 5-pt scale with endpoints of "almost always untrue" and "almost always true" to indicate how well each of 8 statements described their child. Scores ranged from 1-5. High scores indicate greater self-regulation.

  baseline; 3 months; 6 months; 1 year

• Change From Baseline in Sense of Parenting Importance Across 12 Months (Parent Report)

  Using a measure developed for the purposes of this study, parents were provided with a list of 14 parenting skills that closely corresponded to skills that were supported in the FCU Online parenting curriculum, shich as "providing praise and encouragement for good behavior" and "setting clear rules and expectations for behavior." For each parenting skill, parents were asked to indicate the importance of this skill during the middle school years using a 5-point scale with endpoints of "not at all important" and "very important." Scores ranged from 1-5. Higher scores indicate higher endorsement of the importance of parenting skills.

  baseline; 3 months; 6 months; 1 year

• Change From Baseline in Sense of Parenting Confidence Across 12 Months (Parent Report)

  Using a measure developed for the purposes of this study, parents were provided with a list of 14 parenting skills that closely corresponded to skills that were supported in the FCU Online parenting curriculum, shich as "providing praise and encouragement for good behavior" and "setting clear rules and expectations for behavior." For each parenting skill, parents were asked to indicate their level of confidence in using each skill with their child using a 5-point scale with endpoints of "not at all confident" and "very confident." Scores ranged from 1 to 5. Higher scores indicate greater confidence in using parenting skills.

  baseline; 3 months; 6 months; 1 year

• Change From Baseline in Parenting Self-Efficacy Across 12 Months (Parent Report)

  Parenting self-efficacy was assessed with 8 self-report items adapted from the Parenting Task Checklist. Using a 5-pt scale with endpoints of "not confident at all" and "very confident," parents were asked to indicated their level of confidence in handling 8 negative child behaviors such as "your child arguing with you about rules" and "your child's mood swings." Scores ranged from 0 to 4. Higher scores indicate greater parenting confidence/ self-efficacy.

  baseline; 3 months; 6 months; 1 year

• Change From Baseline in Youth Conduct Problems Across 12 Months (Parent Report)

  Parents reported on their child's problem behavior using the Strengths and Difficulties Questionnaire (SDQ), a 25-item brief behavioral screening questionnaire that consists of 5 subscales with 5 questions each. The 5 subscales are conduct problems, emotional problems, hyperactivity, peer problems, and prosocial behavior. Parents were asked to indicate the extent to which statements were true of their child's behavior in the past month using a 3-pt scale (not true, somewhat true, and certainly true). The conduct problems subscale included items such as "often loses temper" and "often fights with other youth or bullies them." Scores ranged from 0 to 10. High scores indicate greater conduct problems.

  baseline; 3 months; 6 months; 1 year

• Change From Baseline in Youth Hyperactivity Across 12 Months (Parent Report)

  Parents reported on their child's problem behavior using the Strengths and Difficulties Questionnaire (SDQ), a 25-item brief behavioral screening questionnaire that consists of 5 subscales with 5 questions each. The 5 subscales are conduct problems, emotional problems, hyperactivity, peer problems, and prosocial behavior. Parents were asked to indicate the extent to which statements were true of their child's behavior in the past month using a 3-pt scale (not true, somewhat true, and certainly true). The hyperactivity subscale included items such as "restless, overactive, cannon sit still for long" and "easily distracted, concentration wanders." Scores ranged from 0 to 10. High scores indicate greater hyperactivity.

  baseline; 3 months; 6 months; 1 year

• Change From Baseline in Youth Emotional Problems Across 12 Months (Parent Report)

  Parents reported on their child's problem behavior using the Strengths and Difficulties Questionnaire (SDQ), a 25-item brief behavioral screening questionnaire that consists of 5 subscales with 5 questions each. The 5 subscales are conduct problems, emotional problems, hyperactivity, peer problems, and prosocial behavior. Parents were asked to indicate the extent to which statements were true of their child's behavior in the past month using a 3-pt scale (not true, somewhat true, and certainly true). The emotional problems subscale included items such as "many worries or often seemed worried" and "often unhappy, depressed, or tearful." Scores ranged from 0 to 10. High scores indicate greater emotional problems.

  baseline; 3 months; 6 months; 1 year

Study Arms (3)

Web/ Mobile-only

EXPERIMENTAL

Participants will complete the FCU online independently, without the help of a coach.

Behavioral: FCU-Online, web/ mobile only

Web/mobile + coach

ACTIVE COMPARATOR

Participants will complete the FCU online and will be contacted by a family coach. The coach will conduct motivational interviewing and provide support to parents via phone. Participants in this condition will have contact with a coach at least 2 times.

Behavioral: FCU-Online, web/ mobile + coach

Wait list control

NO INTERVENTION

Participants in this condition will receive "middle school as usual", meaning that they will continue to receive whatever services are normally provided by the middle school during the year of their participation in the study. Once their research participation is completed (i.e., after they complete their final follow-up survey), participants in this condition will be offered the opportunity to use the FCU-Online website if they wish, without the support of a coach. No additional data will be collected.

Interventions

FCU-Online, web/ mobile only BEHAVIORAL

Participants will be invited to complete the FCU via the FCU-Online website. They will complete an assessment, receive computer-generated feedback, and access to skills units designed to teach parents the importance of using specific parenting skills, provide practice opportunities to try these skills, and tools to track their use of these parenting skills and any associated changes in child behavior.

Web/ Mobile-only

FCU-Online, web/ mobile + coach BEHAVIORAL

Participants will be invited to complete the FCU via the FCU-Online website. They will complete an assessment, receive computer-generated feedback, and access to skills units designed to teach parents the importance of using specific parenting skills, provide practice opportunities to try these skills, and tools to track their use of these parenting skills and any associated changes in child behavior. Participants will also have access to a "family coach" who will motivate parents to enhance parenting skills and provide support while they are learning to use these skills.

Web/mobile + coach

Eligibility Criteria

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

You may qualify if:

• enrollment of child in 6th or 7th grade at one of the 6 participating middle schools;
• caregivers are the parent or legal guardian of the participating youth;
• caregivers have web access at home or are willing to access the web via computers located in the school or public library

You may not qualify if:

• children with severe developmental disabilities or physical disabilities (e.g., autism, genetic disorders, Down syndrome) will not be eligible to participate.

Sponsors & Collaborators

• University of Oregon: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Oregon

Portland, Oregon, 97209, United States

Location

Related Publications (2)

• Stormshak E, Connell A, Mauricio AM, McLaughlin M, Caruthers A. Digital Health Delivery of Parenting Skills to Improve Conduct Problems in Middle School Youth Across Two Distinct Randomized Trials. Prev Sci. 2025 May;26(4):582-591. doi: 10.1007/s11121-024-01750-2. Epub 2024 Nov 18.

  PMID: 39556238 DERIVED

• Danaher BG, Seeley JR, Stormshak EA, Tyler MS, Caruthers AS, Moore KJ, Cardenas L. The Family Check-Up Online Program for Parents of Middle School Students: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2018 Jul 18;7(7):e11106. doi: 10.2196/11106.

  PMID: 30021712 DERIVED

MeSH Terms

Conditions

Substance-Related Disorders; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Dr. Allison Caruthers
• Organization: University of Oregon Prevention Science Institute

ascaru@uoregon.edu

503-412-3770

Study Officials

• Elizabeth Stormshak, PhD

  University of Oregon

  PRINCIPAL INVESTIGATOR

• John Seeley, PhD

  University of Oregon

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Knight Chair and Professor, College of Education, and Director, Prevention Science Institute

Model Details: Participants will be randomly assigned to one of three conditions: a web/mobile-only condition, a web/mobile + coach condition, or a wait list control group who will receive the web/mobile-only treatment one year after enrolling in the study.

Study Record Dates

• First Submitted: February 12, 2017
• First Posted: February 23, 2017
• Study Start: February 21, 2017
• Primary Completion: September 30, 2019
• Study Completion: September 30, 2019
• Last Updated: December 19, 2023
• Results First Posted: December 19, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)