Family Communication Intervention for Preventing Adolescent Substance Use

Overseen By Associate Director, Pre-Award Research Administration

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Tufts University

Disqualifiers: Developmental disabilities, Language barrier

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

1000 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a program that helps parents talk to their kids about drugs and alcohol during family meals. It targets parents of kids in grades 5-7. The program includes a session, regular calls, and text message tips to improve family communication and prevent substance use.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the treatment Improving nutrition and physical activity among youth, The SUPPER Project?

Research shows that engaging parents in interventions that focus on both nutrition and substance use prevention can lead to positive changes in dietary habits and help maintain substance use prevention outcomes among adolescents. For example, a study found that adolescents in a program targeting both areas increased their fruit and fiber intake and had lower intentions to use substances. ^{1 2 3 4 5}

Is the Family Communication Intervention for Preventing Adolescent Substance Use safe for humans?

The studies on similar interventions, like Families Preparing the New Generation Plus, show positive changes in diet and substance use prevention without any reported safety concerns, suggesting it is generally safe for humans. ^{2 4 6 7 8}

How does the Family Communication Intervention for Preventing Adolescent Substance Use differ from other treatments?

This treatment is unique because it focuses on improving parent-child communication about substance use through regular family meals, making it less time-consuming and resource-intensive compared to other programs. It also combines nutrition and physical activity improvements, which are not typically included in standard substance use prevention programs. ^{2 3 4 9 10}

Research Team

Margie Skeer, ScD, MPH, MSW

Principal Investigator

Tufts University School of Medicine

Eligibility Criteria

This trial is for parents or guardians with a child in 5th-7th grade, who live with the child at least half the time. They must be able to understand English or Spanish well enough to participate in study procedures and agree to discuss substance use harms during family meals.

Inclusion Criteria

Parental consent and child assent are obtained.

I am the custodial parent and live with my child at least half the time.

My child is in 5th to 7th grade at the project's start.

Exclusion Criteria

Parents or families who are not able to speak, read, and understand English or Spanish well enough to complete study procedures.

My child has a developmental disability that makes understanding assessments hard.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Parents participate in a one-hour session with an interventionist and receive a follow-up phone call. They also receive text messages with reminders and tips over a three-month period.

3 months

1 visit (in-person or remote), 1 follow-up call

Follow-up

Participants are monitored for changes in parent-child communication and substance use expectancies.

18 months

Treatment Details

Interventions

• Improving nutrition and physical activity among youth
• The SUPPER Project

Trial Overview The study tests a new way of preventing substance misuse by improving parent-child communication. It encourages families to spend quality time together, particularly during meals, where they can talk about the dangers of alcohol and drug use.

Participant Groups

Group I: Substance Use Prevention Intervention Experimental Treatment 1 Intervention

Parents will be given a handbook specific to the gender of their child that provides information and advice communication and substance use prevention. Parents will then participate in a one-hour session with an interventionist where the main points in the handbook will be reviewed and they will fill out an action plan on how to make changes in communication about substances with their child. The interventionist will also provide parents with a referral packet. Two weeks after the live session, participants will have a half-hour follow-up phone call with the same study interventionist. For the home-based component, parents will receive two messages each week with reminders and tips that reinforce the information covered in the handbook. Finally, participants will receive a magnet about the importance of family meals that they will be instructed to put on their refrigerators.

Group II: Nutrition, Physical Activity, and Weight Talk Comparison Active Control 1 Intervention

For the comparison condition, after the baseline assessment, parents will receive a handbook on nutrition and physical activity entitled: "Healthy Eating \& Physical Activity Across Your Lifespan: Helping your Child - Tips for Parents". This handbook, which is adapted from the handbook developed by the National Institute of Diabetes and Digestive and Kidney Diseases and the Weight Control Information Network, is approximately the same length as the intervention handbook and is available in English and Spanish. It is given with an insert on reducing weight talk and weight teasing in the family. Parents will also receive a magnet with a message about nutrition and exercise. To control for contact time, these participants will meet live with a study staff member two weeks after receiving the handbook, complete an action plan, and have the 30-minute call, as well as receive two text messages twice per week for 13 weeks with tips and reminders from the comparison handbook and insert.

Who Is Running the Clinical Trial?

Tufts University

Lead Sponsor

Trials

271

Recruited

595,000+

Brown University

Collaborator

Trials

480

Recruited

724,000+

Findings from Research

The adaptation of the Familias Unidas intervention for obesity prevention in Hispanic adolescents involved input from experts and families, leading to a program that emphasizes improved family health, nutrition education, and physical activity engagement.

Pilot testing showed that parents were enthusiastic about hands-on nutrition training, and adolescents expressed a desire for more joint physical activities with their parents, highlighting the importance of family involvement in obesity prevention efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Familias Unidas for Health and Wellness: Adapting an Evidence-Based Substance Use and Sexual Risk Behavior Intervention for Obesity Prevention in Hispanic Adolescents. St George, SM., Messiah, SE., Sardinas, KM., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Family functioning: associations with weight status, eating behaviors, and physical activity in adolescents. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Family Mealtime Communication in Single- and Dual-Headed Households Among Hispanic Adolescents With Overweight and Obesity. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Randomized controlled trial to test the efficacy of a brief, communication-based, substance use preventive intervention for parents of adolescents: Protocol for the SUPPER Project (Substance Use Prevention Promoted by Eating family meals Regularly). [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Diet Outcomes from a Randomized Controlled Trial Assessing a Parenting Intervention Simultaneously Targeting Healthy Eating and Substance Use Prevention among Hispanic Middle-School Adolescents. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Direct and indirect effects of a family-based intervention in early adolescence on parent-youth relationship quality, late adolescent health, and early adult obesity. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Methods and rationale to assess the efficacy of a parenting intervention targeting diet improvement and substance use prevention among Latinx adolescents. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Parental involvement and association with adolescents' fruit and vegetable intake at follow-up: Process evaluation results from the multi-component school-based Boost intervention. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Evaluation of the Computer-Based Intervention Program Stayingfit Brazil to Promote Healthy Eating Habits: The Results from a School Cluster-Randomized Controlled Trial. [2020]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Familias Unidas for Health and Wellness: Adapting an Evidence-Based Substance Use and Sexual Risk Behavior Intervention for Obesity Prevention in Hispanic Adolescents. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Testing a Brief Substance Misuse Preventive Intervention for Parents of Pre-Adolescents: Feasibility, Acceptability, Preliminary Efficacy. [2023]