Primary Connections for Youth and Families
- Conditions
- Substance Use
- Interventions
- Behavioral: Family ScreeningBehavioral: Standard ScreeningBehavioral: Standard PsychoeducationBehavioral: Family PsychoeducationBehavioral: Standard Brief Negotiated Interview (BNI)Behavioral: Family Brief Negotiated Interview (BNI)Behavioral: Standard Referral to Treatment (RT)Behavioral: Family Facilitated Conversation (FC) & Referral to Treatment (RT)
- Registration Number
- NCT05964010
- Lead Sponsor
- The National Center on Addiction and Substance Abuse at Columbia University
- Brief Summary
The goal of this clinical trial is to compare a standard adolescent-only approach to substance use screening, brief intervention, and referral to treatment to a in primary care settings. Primary outcomes (AOD use, co-occurring behavior problems, parent-youth communication about AOD use) and secondary outcomes (adolescent quality of life, therapy attendance) are assessed at screen/initial and 3, 6, 9, and 12 months follow-up.
- Detailed Description
This randomized effectiveness trial compares a standard adolescent-only approach (SBIRT-A-Standard) versus a family-based approach (SBIRT-A-Family) in which caregivers are systematically included in screening, intervention, and referral activities. The study includes N = 2,300 adolescents (age 12 - 17) and their caregivers attending one of three hospital-affiliated pediatric settings serving diverse patients in major urban areas. Study recruitment, initial screening, randomization, and all SBIRT-A activities occur during a single pediatric visit. SBIRT-A procedures are delivered primarily in digital format on hand-held tablets using both patient-facing and provider-facing programming. Primary outcomes (AOD use, co-occurring behavior problems, parent-youth communication about AOD use) and secondary outcomes (adolescent quality of life, therapy attendance) are assessed at screen/initial and 3, 6, 9, and 12 months follow-up. The study is well powered to conduct all planned main and moderator (age, sex, race/ethnicity, youth AOD risk status) analyses.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 2300
- Youth aged 12-17 years with a primary caregiver (i.e., parental figure) also in attendance to primary care appointment
- Youth and caregiver are fluent in English or Spanish
- Youth and caregiver are capable of using audio-assisted informed consent procedures and independently operating a hand-held tablet device
- Youth and caregiver are complete routine site AOD risk screening questions prompted during PC visit intake
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SBIRT-A-Standard Standard Brief Negotiated Interview (BNI) Standard adolescent-only approach to screening, brief intervention, and referral to treatment for adolescent substance use. SBIRT-A-Standard Standard Psychoeducation Standard adolescent-only approach to screening, brief intervention, and referral to treatment for adolescent substance use. SBIRT-A-Standard Standard Referral to Treatment (RT) Standard adolescent-only approach to screening, brief intervention, and referral to treatment for adolescent substance use. SBIRT-A-Family Family Screening 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. SBIRT-A-Standard Standard Screening Standard adolescent-only approach to screening, brief intervention, and referral to treatment for adolescent substance use. SBIRT-A-Family Family Psychoeducation 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. SBIRT-A-Family Family Brief Negotiated Interview (BNI) 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. SBIRT-A-Family Family Facilitated Conversation (FC) & Referral to Treatment (RT) 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.
- Primary Outcome Measures
Name Time Method Change in Assessment of Liability and Exposure to Substance use and Antisocial Behavior (ALEXSA; Ridenour et al., 2009) Initial and 3, 6, 9, and 12 months follow-up Youth report audio-assisted self-interview that measures frequency of alcohol and other drug use. This study will use 6 items. The first three items assess whether youth have ever used alcohol, tobacco, and marijuana (yes/no). If use of a substance is reported, a follow-up question is presented regarding frequency of use e.g., "How often do you \[use tobacco/drink alcohol/ use marijuana\] right now?" with response options of 0 = never to 5 = every day for each substance. For each substance, scores range from 0 to 5 with higher scores indicate more frequent use.
Change in Youth Risk Index (ALEXSA; Ridenour et al., 2009) Initial and 3, 6, 9, and 12 months follow-up Youth and caregiver report measure assessing risk factors associated with youth alcohol and other drug use. The YRI contains 23 items from the ALEXSA measuring risk factors associated with youth substance use including anger coping, impulsivity, distractibility, disinhibition, peer conduct problems, and susceptibility to peer pressure. 17 items are rated on a 4-point likert scale from 0 to 3 and 6 items are measured on a 6-point scale from 0 to 5+. Total score ranges from 0 to 81 with higher scores indicating more risk factors.
Change in Parent-Teen Alcohol and Other Drug Use Communication Quality (Spijkerman et al., 2008) Initial and 3, 6, 9, and 12 months follow-up 6-item youth and caregiver report measure assessing quality of communication about key alcohol and other drug use issues. Items are rated on a 5-point scale from 0 = never to 4 = very often. Total score ranges from 0 to 20 with higher scores indicating greater communication quality.
Change in Brief Problem Monitor (BPM; Achenbach & Rescorla, 2001) Initial and 3, 6, 9, and 12 months follow-up A 19-item youth and caregiver report component of the well-validated Achenbach youth behavior problem assessment system that yields normed scores with clinical cut levels for three problem domains: internalizing (anxiety, depression, somatic complaints), externalizing (aggression, conduct problems), inattention/impulsivity. Items are rated on a 3-point scale from 0 = never to 2 = often. Total score ranges from 0 to 38 with higher scores representing more problems.
Change in Pediatric Quality of Life Inventory 4.0 (PedsQL 4.0; Children's Hospital and Health Center, San Diego, CA) Initial and 3, 6, 9, and 12 months follow-up Youth and caregiver report measure assessing youth functioning in different domains. This study will use the Social and School scales. Each scale has 5 items and items are scored on a 5-point scale from 0 = never a problem to 4 = almost always a problem. Some items are reversed scored such that each scale ranges from 0 to 20 with higher scores indicating better quality of life.
Change in Services Assessment for Children and Adolescents (SACA; Stiffman et al., 2000) Initial and 3, 6, 9, and 12 months follow-up Caregiver report measure assessing youth's past and current use of inpatient, outpatient, and school-based behavioral health services. Items are dichotomous (yes/no) and the scale ranges from 0 (no services) to 3 (3 types of services) for past and current use such that higher numbers indicate more services.
Change in Parent-Teen Alcohol and Other Drug Use Communication Frequency (Koning et al., 2014) Initial and 3, 6, 9, and 12 months follow-up 6-item youth and caregiver report measure assessing frequency of communication about key alcohol and other drug use issues. Items are rated on a 5-point scale from 0 = never to 4 = very often. Total score ranges from 0 to 20 with higher scores indicating greater communication frequency.
- Secondary Outcome Measures
Name Time Method Car Relax Alone Forget Family Trouble (CRAFFT; Knight et al., 2003) Initial screening Youth-report tool that begins with questions about number of days during the past 12 months, and then the past 3 months, during which the patient used alcohol, cannabis, nicotine, illegal drugs, or prescription medication for the purpose of getting high. The 12-month period scores range from 0 to 365 and the 3-month period scores range from 0 to 90 with higher scores indicating more frequent use. If AOD is endorsed, six follow-up dichotomous (yes/no) questions are asked about reasons for use: use to Relax, use while Alone, Forget things you did while intoxicated, Family or friends tell you to reduce use, gotten into Trouble while using.
If AOD is denied, 1 follow-up dichotomous (yes/no) question is asked about whether the individual has ridden in a Car driven by someone (including self) who was intoxicated (yes/no).Hooked on Nicotine Checklist (HONC; DiFranza et al., 2002) Initial screening 10-item youth report of nicotine dependence completed by patients who report any days of using a vaping device containing nicotine, or any tobacco products, during the past 30 days. Items are dichotomous (yes/no) and total score ranges from 0 to 10 with higher scores indicating greater dependence.
Caregiver Estimate of Youth Alcohol and Other Drug Use (Levy et al., 2016; Levy et al., 2021) Initial screening Caregiver Estimate of Youth AOD Use was created for this study based on the Screening 2 Brief Intervention tool (Levy et al., 2016; Levy et al., 2021); it asks caregivers to estimate how often over the past 3 months their teen used alcohol, cannabis, nicotine, prescription drug misuse, inhalants, herbs/synthetic drugs, and other drugs on the same scale. Total score ranges using a 4 point scale from 0 = never to 3 = weekly. Total score ranges from 0 to 21 with higher scores indicating more frequent substance use.
Trial Locations
- Locations (1)
Columbia University Medical Center
🇺🇸New York, New York, United States