Family Interventions for Adolescent Substance Use

(PCYF Trial)

Overseen By Nicole P Porter, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: The National Center on Addiction and Substance Abuse at Columbia University

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

Compensation: Varies

Number of Visits: 6

2300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two methods to support teens dealing with substance use. One method focuses solely on the teen, while the other involves their family. The goal is to determine which approach better improves communication, reduces substance use, and enhances the teen’s quality of life. Teens who use substances and have a caregiver willing to participate in primary care visits may be suitable for this trial. As an unphased trial, it offers a unique opportunity for teens and their families to explore new ways to improve their lives and relationships.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these family interventions are safe for adolescents?

Research has shown that family-based treatments for teen substance use are generally safe and well-received.

For the Family Brief Negotiated Interview (BNI), studies indicate that structured talks can address substance use without serious side effects. These discussions focus on building trust, weighing pros and cons, and creating action plans, aiming to be supportive rather than intrusive.

The Family Facilitated Conversation (FC) & Referral to Treatment (RT) approach is also considered safe. Providers meet with both teens and their caregivers to discuss the risks of substance use. This method has been used with thousands of young people, with no reports of major negative effects.

Family Psychoeducation is another safe method. It involves teaching families about substance use and has been shown to help reduce it in teens. This approach focuses on sharing information and building understanding.

Overall, these family-based methods emphasize communication and education, which are low-risk and supported by research showing positive results in reducing substance use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these family-focused interventions for adolescent substance use because they actively involve caregivers in the treatment process, which is a shift from the standard adolescent-only approach. The Family Brief Negotiated Interview (BNI) and Family Facilitated Conversation (FC) integrate families into the screening and intervention process, potentially enhancing support and accountability for the teen. Additionally, Family Psychoeducation aims to educate families about substance use, equipping them with tools to better support their child's recovery journey. This holistic, family-inclusive approach may lead to more effective and sustained outcomes compared to traditional methods that primarily focus on the individual adolescent.

What evidence suggests that this trial's treatments could be effective for adolescent substance use?

This trial will compare different family-centered approaches to adolescent substance use treatment. Research has shown that involving families in treatment can help reduce substance use in teenagers. For example, the Family Brief Negotiated Interview (BNI), one approach in this trial, involves family members in the treatment process, improving communication and support. Another approach, Family Facilitated Conversation (FC) and Referral to Treatment (RT), addresses how family relationships affect substance use. Additionally, Family Psychoeducation, also studied in this trial, has improved family functioning, which can protect against substance use. Overall, these family-centered approaches show promise in helping teenagers recover by leveraging family support. ^{1 2 3 5 6}

Who Is on the Research Team?

Aaron Hogue, PhD

Principal Investigator

Partnership to End Addiction

Are You a Good Fit for This Trial?

This trial is for youths aged 12-17 with substance use disorders, who come to primary care appointments with a caregiver. Both must be fluent in English or Spanish and able to use a tablet for consent procedures.

Inclusion Criteria

I am between 12-17 years old and my parent will come to my doctor's appointments.

You and your caregiver are expected to answer alcohol and drug-related risk assessment queries during the initial medical appointment.

You and your caregiver are proficient in either English or Spanish.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 visit

1 visit (in-person)

Intervention

Participants receive either a standard adolescent-only approach or a family-based approach to substance use screening, brief intervention, and referral to treatment

1 visit

1 visit (in-person)

Follow-up

Participants are monitored for primary and secondary outcomes at 3, 6, 9, and 12 months

12 months

4 visits (virtual or in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Family Brief Negotiated Interview (BNI)
• Family Facilitated Conversation (FC) & Referral to Treatment (RT)
• Family Psychoeducation

Trial Overview The study compares standard adolescent-only substance abuse interventions against family-inclusive approaches. It measures drug use, behavior problems, communication about drugs, quality of life, and therapy attendance over one year.

How Is the Trial Designed?

Group I: SBIRT-A-Family Experimental Treatment 4 Interventions

Family-based approach to screening, brief intervention, and referral to treatment for adolescent substance use in which caregivers are systematically included in screening, intervention, and referral activities.

Group II: SBIRT-A-Standard Active Control 4 Interventions

Standard adolescent-only approach to screening, brief intervention, and referral to treatment for adolescent substance use.

Family Brief Negotiated Interview (BNI) is already approved in United States for the following indications:

Approved in United States as Family Brief Negotiated Interview for:

• Substance use screening and intervention in adolescents

Who Is Running the Clinical Trial?

The National Center on Addiction and Substance Abuse at Columbia University

Lead Sponsor

Trials

13

Recruited

3,500+

Columbia University

Collaborator

Trials

1,529

Recruited

2,832,000+

Abt Associates

Industry Sponsor

Trials

11

Recruited

167,000+

UConn Health

Collaborator

Trials

218

Recruited

59,100+

Northwestern University Feinberg School of Medicine

Collaborator

Trials

42

Recruited

15,500+

Massachusetts General Hospital

Collaborator

Trials

3,066

Recruited

13,430,000+

Boston Children's Hospital

Collaborator

Trials

801

Recruited

5,584,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Boston Medical Center

Collaborator

Trials

410

Recruited

890,000+

Published Research Related to This Trial

Beardslee's family intervention (BFI) was reported to improve openness about substance use disorders within families, which was a key positive outcome for both children and parents six months after the intervention.

Children participating in the BFI showed a perceived reduction in psychological symptoms, and parents noted improvements in their children's wellbeing, suggesting that BFI can be an effective preventive method for families affected by parental substance use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Talking about parental substance abuse with children: eight families' experiences of Beardslee's family intervention. Pihkala, H., Dimova-Bränström, N., Sandlund, M.[2018]

A time-limited and intensive format of Parent-Child Interaction Therapy (PCIT) was found feasible for 15 families with young children aged 2-5 years who had experienced a traumatic brain injury (TBI) and exhibited behavior problems.

The intervention led to high caregiver satisfaction and significant reductions in child behavior issues, with 71% of families completing the program and showing improvements at post-assessment and follow-up, suggesting it may effectively address challenges following early childhood TBI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensive Parent-Child Interaction Therapy for Children with Traumatic Brain Injury: Feasibility Study. Garcia, D., Rodríguez, GM., Lorenzo, NE., et al.[2022]

Family-based preventive interventions are becoming an important approach to reduce substance use and antisocial behavior, focusing on high-risk and adolescent populations.

Key recommendations for improving these interventions include customizing strategies for individual families, collaborating with various social systems, and combining insights from both prevention and treatment fields.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family-based preventive intervention: an approach to preventing substance use and antisocial behavior. Hogue, A., Liddle, HA.[2022]

A study involving 125 adolescents aged 13 to 17 showed that both individual motivational interviews (IMI) and those combined with family motivational interviews (Family Check-Up, FCU) significantly reduced alcohol use after an emergency department visit for alcohol-related issues.

The combination of IMI and FCU led to a greater reduction in high-volume drinking days at the 3-month follow-up compared to IMI alone, suggesting that involving family support can enhance the effectiveness of motivational interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Individual and family motivational interventions for alcohol-positive adolescents treated in an emergency department: results of a randomized clinical trial. Spirito, A., Sindelar-Manning, H., Colby, SM., et al.[2022]

Brief strategic family therapy (BSFT) is being evaluated in a multisite clinical trial to determine its effectiveness in reducing drug use and behavior problems among adolescents compared to standard treatment (TAU).

The study aims to assess not only the reduction in drug use and conduct issues but also improvements in family functioning and prosocial behaviors, highlighting the comprehensive approach of BSFT in addressing adolescent issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief strategic family therapy for adolescent drug abusers: a multi-site effectiveness study. Robbins, MS., Szapocznik, J., Horigian, VE., et al.[2021]

Family-based interventions for preventing substance use disorders in children and adolescents are effective when they focus on enhancing developmental competencies and family resources, rather than just addressing substance use directly.

Evidence-based family treatment programs like Multisystemic Therapy and Functional Family Therapy show small-to-medium effects, but there is a need for more research on their effective components and how to implement these programs effectively in communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Current State of Family-Based Prevention and Therapy of Substance-Use Disorders in Children and Adolescents: A Review]. Arnaud, N., Sack, PM., Thomasius, R.[2019]

A proactive assessment and intervention approach for students with traumatic brain injury (TBI) focuses on anticipating cognitive-communicative challenges and creating solutions, emphasizing the importance of early intervention.

The intervention process actively involves family members, teachers, and peers, ensuring that support strategies are integrated into various settings like home, school, and work, which enhances the effectiveness of the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A proactive model for treating communication disorders in children and adolescents with traumatic brain injury. Blosser, JL., DePompei, R.[2004]

Adolescent substance use can lead to serious long-term issues such as dependence, criminal behavior, and mental health disorders, highlighting the need for effective family-based interventions.

The article reviews various evidence-based family treatments for adolescent substance use, including multisystemic therapy and functional family therapy, emphasizing their outcomes and implementation factors to help clinicians choose the best approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family-Based Treatments for Adolescent Substance Use. Horigian, VE., Anderson, AR., Szapocznik, J.[2020]

Family involvement in addiction treatment can significantly improve outcomes, including treatment entry and completion, yet current services often focus on individuals rather than families.

This scoping review aims to identify the extent and nature of existing evidence on family interventions in addiction treatment, highlighting gaps to inform future research and best practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family-focused practices in addictions: a scoping review protocol. Kourgiantakis, T., Ashcroft, R.[2018]

The study focused on implementing Brief Strategic Family Therapy (BSFT) as a drug intervention for adolescents in eight community substance abuse treatment programs, highlighting its evidence-based approach.

Researchers worked closely with treatment programs to ensure the trial was both scientifically rigorous and applicable to diverse adolescent substance abuse settings, utilizing insights from various research methodologies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transporting clinical research to community settings: designing and conducting a multisite trial of brief strategic family therapy. Robbins, MS., Alonso, E., Horigian, VE., et al.[2021]

Family-based approaches for treating adolescent substance abuse show positive outcomes in therapy engagement and retention, as well as improvements in various areas of adolescent and family functioning.

Future research should focus on how to effectively deliver evidence-based family treatments in everyday practice, ensuring that therapeutic alliances and core techniques are maintained for better treatment fidelity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family-based treatment for adolescent substance abuse: controlled trials and new horizons in services research. Hogue, A., Liddle, HA.[2021]

The Culturally Informed and Flexible Family-Based Treatment for Adolescents (CIFFTA) showed significant improvements in self-reported drug use and parenting practices among Hispanic adolescents with substance abuse disorders, based on a small randomized trial with 28 participants over 8 months.

CIFFTA outperformed traditional family therapy in reducing drug use and enhancing parenting practices, indicating its potential effectiveness, but further research with a larger sample size is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary results for an adaptive family treatment for drug abuse in Hispanic youth. Santisteban, DA., Mena, MP., McCabe, BE.[2021]

The Treatnet Family intervention, designed for adolescents with substance use disorders, was successfully implemented by 23 trained practitioners in community settings in Jakarta, Indonesia, over a 6-week period.

Supervisors observed that practitioners adhered to the core skills of the Treatnet Family intervention, indicating that the program can be effectively delivered in real-world settings with fidelity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fidelity Assessment of the Treatnet family (TF): A family-based intervention for adolescents with substance use disorders and their families. Busse, A., Kashino, W., Suhartono, S., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11179044/

Standard Versus Family-Based Screening, Brief Intervention ... The tutorial focuses on adolescent AOD prevalence rates and related behavioral symptoms, AOD use neurobiology and its relation to adolescent health, and common ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05964010

NCT05964010 | Primary Connections for Youth and Families The goal of this clinical trial is to compare a standard adolescent-only approach to substance use screening, brief intervention, and referral to treatment ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4475574/

Brief Family Based Intervention for Substance Abusing ... This article discusses the theoretical foundations as well as the application of the Family Check-up, a brief family-based intervention for adolescent substance ...

4. withpower.com withpower.com/trial/phase-substance-related-disorders-10-2023-a085b

Family Interventions for Adolescent Substance Use The goal of this clinical trial is to compare a standard adolescent-only approach to substance use screening, brief intervention, and referral to treatment ...

5. schoolhealthcenters.org schoolhealthcenters.org/resource/sbirt-quick-guides/brief-interventions/

SBIRT Quick Guide: Brief Interventions Brief interventions are structured conversations designed to address alcohol and/or drug use among youth who are using substances, but do not need specialty SUD ...

6. scdhhs.gov scdhhs.gov/sites/dhhs/files/qtip/Adolescent%20Substance%20Use%20%20UPDATED%20%20Harris.pdf

Scope, Screening, and Brief Interventions Brief Negotiated Interview (BNI). Five Steps: 1. Build Rapport. 2. Explore Pros and Cons. 3. Provide Feedback. 4. Use Readiness Ruler. 5. Negotiate an Action ...