Substance Use DisordersNCT05397691
Substance Use Prevention for Youth With Parents in Recovery
A study testing Modified Family Talk in people with Substance Use Disorders, run by Brown University at 1 site in United States.
Trial summary
Risk for substance use disorder (SUD) begins early in the life course. Although preventing and decreasing illicit and nonmedical drug use among youth is an urgent public health priority, there are currently few evidence-based prevention strategies feasible for delivery in the primary care setting. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Substance Use Disorders
- What is being tested?
- Modified Family Talk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Aug 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 12-18 years without diagnosed SUD
- Comfortable speaking English or Spanish
- 18 years or older
- Receiving treatment for SUD
- Receiving substance use care in the CODAC system
- Comfortable speaking English or Spanish
Who cannot join
- Presence of acute family crisis, such as recent death, incarceration, separation, divorce, or other stressor
- Parent or youth with cognitive limitation or intellectual disability
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Substance Use Prevention for Youth With Parents in Recovery: A Pilot Randomized Controlled Trial
Risk for substance use disorder (SUD) begins early in the life course. Although preventing and decreasing illicit and nonmedical drug use among youth is an urgent public health priority, there are currently few evidence-based prevention strategies feasible for delivery in the primary care setting. The investigators propose a three-year plan to collect critical pilot data to pilot test and optimize a dyadic intervention that aims to increase family resilience, strengthen coping skills, help families plan for the future, and prevent youth SUD.
The 'prototype' for the intervention approach is Family Talk, an evidence-based parent-youth dyadic intervention that can be delivered within the existing infrastructure of the patient-centered medical home. The investigators have made preliminary adaptations to the model in preparation for testing. To prepare for a subsequent efficacy study, a two-arm pilot randomized controlled trial of the intervention with 40 parent-youth dyads to optimize the intervention model will be conducted. The feasibility of the intervention will be evaluated. In addition, empiric estimates of study parameters to inform the planning of a fully powered randomized controlled trial and plausible intervention targets using semi-structured qualitative interviews will be obtained.
Read the detailed description
Within the context of a pilot randomized controlled trial, the objectives are to: 1. Optimize the content and delivery of the intervention through an iterative series of quality improvement cycles informed by structured feedback from parents, youth, and intervention providers after each session; 2. Field test study logistics, including participant recruitment, willingness to consent to a randomized trial; loss to follow-up; the acceptability and feasibility of the study measures; and 3. Obtain empiric estimates of study parameters to inform future clinical trial design, including within-group standard deviation of continuous measures; correlations of repeated measures; and proportion of control group subjects who experience each outcome. The products at the end of the pilot study will be an optimized intervention model, developed with parent and youth input and ready for efficacy testing; and a set of putative intervention targets ready to be tested in the subsequent trial. The ultimate goal is to develop an effective approach to youth substance use prevention, delivered within the infrastructure of the patient-centered medical home. If successful, this trajectory of work has the potential to identify a novel, family-centered approach to substance use disorder prevention for a high-risk population of youth whose parents are in recovery.
- Conditions
- Substance Use Disorders
- Being tested
- Modified Family Talk, Control-like parameter estimation
- Keywords
- Family Talk, Parent-youth dyad, Family functioning, Coping strategies
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Family TalkOther
The Modified Family Talk intervention consists of six modules, each lasting approximately 60 minutes. Family Talk is intended to be delivered over a period of 12 weeks, with meetings occurring every 1-2 weeks.
Control-like parameter estimationOther
Parameter estimation is designed to emulate best practices around comprehensive, high quality, patient-centered care for adults and youth. Participants will have access to collaborative adult Office Based Addiction Treatment (OBAT) clinical services, multidisciplinary adolescent primary care clinics with co-located adolescent substance use specialists, high quality social work services, integrated behavioral health, and access to patient navigators for assistance connecting to community resources.
| Study group | Role | What they receive |
|---|---|---|
| Intervention refinement arm | Experimental | 20 parent-youth [12-18 years old] dyads will be randomized to this arm and receive the Modified Family Talk intervention. Receives: Other: Modified Family Talk |
| Parameter estimation arm | Experimental | 20 parent-youth dyads randomized to this control-like arm will receive current best practice care in the patient-centered medical home Receives: Other: Control-like parameter estimation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participation metrics
The number of families approached and screened for the project, number ineligible, number refusing participation, and number ultimately enrolled will be assessed
Measured: 12 months
Reasons for not enrolling
An investigator created questionnaire will be obtain the reasons why eligible potential participants did not enroll in the study.
Measured: 12 months
Study attrition rates
The percent of participants will be calculated by dividing the number of participants that complete the study by the total number of participants enrolled.
Measured: 12 months
Number of sessions
The number of sessions delivered by the intervention providers will be tracked.
Measured: throughout the study up to 12 months
Person-time of sessions
The total and average person time for sessions delivered by the intervention providers will be tracked.
Measured: throughout the study up to 12 months
Secondary outcomes (11)
Youth substance use in preceding 90 days
The Timeline Follow-back Interview (TLFB) is a 14 item instrument that will be used to assess substance use in the preceding 90 days and to evaluate for new onset of substance use, as well as increased frequency or intensity of use.
Measured: 90 days
Youth substance use screening
Brief Screener for Tobacco, Alcohol, and other Drugs (BSTAD), a brief, validated instrument designed for use in primary care will be used to screen youth for substance use, including use of tobacco (adapted to include e-cigarettes and vaping products), alcohol, marijuana, prescription medications (including opioids), heroin, and other illicit substance use in the past year.
Measured: 12 months
Family Communication
Family communication will be assessed by the 10-item Family Problem-Solving Communication Index that evaluates family communication patterns in response to problems or conflicts and identifies affirming and incendiary communication patterns. Each item has a choice of answers, which correlate with 0-3 points where 0 = False' 1 = Mostly false' 2 = Mostly true' 3 = True. The answers to different items are added together for an "affirming communication" subscale and an "incendiary communication" subscale. Reverse score items 3 \& 9. For Affirming Communication: items 2' 4' and 6' 8'10 are summed. For Incendiary Communication: items 1' 3' 5' 7' 9 are summed. The subscales can range from 0-15. Higher scores for the affirming communication subscale are more favorable, while lower scores for the incendiary communication subscale are more favorable.
Measured: 3 months, 6 months, 12 months
Family Functioning
The Inventory of Parent and Peer Attachment (IPPA) will be used to assess family functioning. IPPA consists of 25 items for the mother, 25 items for the father, and 25 items for the adolescent and uses a 5-point LIkert scale for each items. The IPPA is scored by reverse-scoring the negatively worded items and then summing the response values in each section. This self-report scale measures youth perceptions of attachment to parents/caregivers along three dimensions: trust, communication, and alienation
Measured: 3 months, 6 months, 12 months
Depression
Depression will be assessed using the Quick Inventory of Depressive Symptomatology (QIDS).Total QIDS scores range from 0 to 27, with scores of 5 or lower indicative of no depression, scores from 6 to 10 indicating mild depression, 11 to 15 indicating moderate depression, 16 to 20 reflecting severe depression, and total scores greater than 21 indicating very severe depression.
Measured: 3 months, 6 months, 12 months
Perceived Stress
Perceived stress will be assessed using the 10 item Perceived Stress Scale (PSS). The range of responses for each item is from 0-4, where 0 = Never 1 = Almost Never 2 = Sometimes 3 = Fairly Often 4 = Very Often. total scores can range from 0 to 40 and higher scores are correlated with more perceived stress.
Measured: 3 months, 6 months, 12 months
Problem solving skills
Problem solving skills will be assessed with the Social Problem Solving Inventory -Revised (SPSI-R). This 25 item instrument measures problem orientation and problem-solving skills in 5 dimensions: positive (PPO) and negative orientation(NPO) ; avoidance (AS); impulsivity (ICS) ; and rationality (RPS). Each dimension subscale scores range from 0 to 20, and the total scores of the SPSI-R: S range from 0 to 100. Higher subscores on PPO and RPS, and lower subscores of NPO, ICS, and AS indicate good social problem solving.
Measured: 3 months, 6 months, 12 months
Self-efficacy coping strategies
Coping strategies will be assessed by the 26 item Coping Self-Efficacy Scale which measures ability to cope with life changes in three domains: problem-focused coping, handling unpleasant thoughts, and getting support from family/friends. Anchor points on the scale are 0 ('cannot do at all'), 5 ('moderately certain can do') and 10 ('certain can do'). A high score - between 17 and 20 - indicates a highly resilient coper, and a low score - between 4 and 13 - suggests a low resilient coper.
Measured: 3 months, 6 months, 12 months
Types of coping strategies
The Brief Coping Orientation to Problems Experienced (COPE) measures 14 different adaptive and problematic coping styles. Respondents rate items on a 4-point Likert scale ranging from 1 (I haven't been doing this at all) to 4 (I've been doing this a lot). Each scale is comprised of 2 items. Higher scores indicate increased utilization of that specific coping strategy. There is no overall total score.
Measured: 3 months, 6 months, 12 months
Social support
Social support will be assessed using the Social Adjustment Scale Self-Report (SAS-SR). It examines social and role functioning in six areas: work; social activities; relationships with family; spouse or partner; parent; member of family unit. Each question is rated on a five-point scale from which subscale means and an overall mean can be obtained. Higher scores denote greater impairment. Role areas not relevant to the respondent can be skipped
Measured: 3 months, 6 months, 12 months
Youth perceptions of peer, sibling, parental substance use
The Personal Experience Inventory will be used to assess this outcome. It assesses 3 domains: peer use (5 items); sibling use (4 items); and parent use (4 items). The response options include Likert scales that correspond to answers such as Never/Once or Twice/Sometimes/Often, Strongly Disagree/Disagree/Agree/Strongly Agree, which in turn correspond to scores of 1-4. Subscale scores can be compared to population norms and cutoffs.
Measured: 3 months, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study start29 Aug 2024
- Primary completion31 Jul 2026
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Use DisordersStudies of the same condition, open and under way.
- More trials run by Brown UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Caroline J Kistin, MD MSc, Principal investigator, Brown University School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05397691
- Sponsor's protocol ID
- 2022003505
- Other IDs
- 1R34DA052836-01A1
- Status last verified
- Aug 2026
- First submitted
- 23 May 2022
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon completion of study analyses and publications, the investigators will make data and non-publishable documentation (such as research protocols, data collection instruments, other findings) available to internal and external bona fide researchers upon request in a timely fashion. The de-identified data will be made available to others only after discussion with the study team and under a formal data-sharing agreement that provides for: 1. commitment to use data for research purposes only and not to identify individual study participants; 2. commitment to use appropriate information technology systems to keep data secure; and 3. commitment to returning or destroying data after analyses are complete. The research team will also work with the Boston University Medical Campus Institutional Review Board (IRB) to assure protection of confidentiality, as necessary.
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Substance Use Prevention for Youth With Parents in Recovery: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05397691
- Acronym / sponsor ID
- 2022003505
- Conditions
- Substance Use Disorders
- Keywords
- Family Talk, Parent-youth dyad, Family functioning, Coping strategies
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH)
- Study start
- 29 Aug 2024 (actual)
- Primary completion
- 31 Jul 2026 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 31 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Risk for substance use disorder (SUD) begins early in the life course. Although preventing and decreasing illicit and nonmedical drug use among youth is an urgent public health priority, there are currently few evidence-based prevention strategies feasible for delivery in the primary care setting. The investigators propose a three-year plan to collect critical pilot data to pilot test and optimize a dyadic intervention that aims to increase family resilience, strengthen coping skills, help families plan for the future, and prevent youth SUD.
The 'prototype' for the intervention approach is Family Talk, an evidence-based parent-youth dyadic intervention that can be delivered within the existing infrastructure of the patient-centered medical home. The investigators have made preliminary adaptations to the model in preparation for testing. To prepare for a subsequent efficacy study, a two-arm pilot randomized controlled trial of the intervention with 40 parent-youth dyads to optimize the intervention model will be conducted. The feasibility of the intervention will be evaluated. In addition, empiric estimates of study parameters to inform the planning of a fully powered randomized controlled trial and plausible intervention targets using semi-structured qualitative interviews will be obtained.
Detailed description
Within the context of a pilot randomized controlled trial, the objectives are to: 1. Optimize the content and delivery of the intervention through an iterative series of quality improvement cycles informed by structured feedback from parents, youth, and intervention providers after each session; 2. Field test study logistics, including participant recruitment, willingness to consent to a randomized trial; loss to follow-up; the acceptability and feasibility of the study measures; and 3. Obtain empiric estimates of study parameters to inform future clinical trial design, including within-group standard deviation of continuous measures; correlations of repeated measures; and proportion of control group subjects who experience each outcome. The products at the end of the pilot study will be an optimized intervention model, developed with parent and youth input and ready for efficacy testing; and a set of putative intervention targets ready to be tested in the subsequent trial. The ultimate goal is to develop an effective approach to youth substance use prevention, delivered within the infrastructure of the patient-centered medical home. If successful, this trajectory of work has the potential to identify a novel, family-centered approach to substance use disorder prevention for a high-risk population of youth whose parents are in recovery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention refinement arm | Experimental | Other: Modified Family Talk20 parent-youth [12-18 years old] dyads will be randomized to this arm and receive the Modified Family Talk intervention. |
| Parameter estimation arm | Experimental | Other: Control-like parameter estimation20 parent-youth dyads randomized to this control-like arm will receive current best practice care in the patient-centered medical home |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 12-18 years without diagnosed SUD
- Comfortable speaking English or Spanish
- 18 years or older
- Receiving treatment for SUD
- Receiving substance use care in the CODAC system
Key exclusion criteria (2 listed)
- Presence of acute family crisis, such as recent death, incarceration, separation, divorce, or other stressor
- Parent or youth with cognitive limitation or intellectual disability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modified Family TalkThe Modified Family Talk intervention consists of six modules, each lasting approximately 60 minutes. Family Talk is intended to be delivered over a period of 12 weeks, with meetings occurring every 1-2 weeks. | Other | Intervention refinement arm |
| Control-like parameter estimationParameter estimation is designed to emulate best practices around comprehensive, high quality, patient-centered care for adults and youth. Participants will have access to collaborative adult Office Based Addiction Treatment (OBAT) clinical services, multidisciplinary adolescent primary care clinics with co-located adolescent substance use specialists, high quality social work services, integrated behavioral health, and access to patient navigators for assistance connecting to community resources. | Other | Parameter estimation arm |
Primary outcome
Participation metrics
Time frame: 12 months
The number of families approached and screened for the project, number ineligible, number refusing participation, and number ultimately enrolled will be assessed
Reasons for not enrolling
Time frame: 12 months
An investigator created questionnaire will be obtain the reasons why eligible potential participants did not enroll in the study.
Study attrition rates
Time frame: 12 months
The percent of participants will be calculated by dividing the number of participants that complete the study by the total number of participants enrolled.
Number of sessions
Time frame: throughout the study up to 12 months
The number of sessions delivered by the intervention providers will be tracked.
Person-time of sessions
Time frame: throughout the study up to 12 months
The total and average person time for sessions delivered by the intervention providers will be tracked.
11 secondary outcomes
Youth substance use in preceding 90 days
Time frame: 90 days
Youth substance use screening
Time frame: 12 months
Family Communication
Time frame: 3 months, 6 months, 12 months
Family Functioning
Time frame: 3 months, 6 months, 12 months
Depression
Time frame: 3 months, 6 months, 12 months
Perceived Stress
Time frame: 3 months, 6 months, 12 months
Problem solving skills
Time frame: 3 months, 6 months, 12 months
Self-efficacy coping strategies
Time frame: 3 months, 6 months, 12 months
Types of coping strategies
Time frame: 3 months, 6 months, 12 months
Social support
Time frame: 3 months, 6 months, 12 months
Youth perceptions of peer, sibling, parental substance use
Time frame: 3 months, 6 months, 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Individual participant dataSharing planned: Yes. Upon completion of study analyses and publications, the investigators will make data and non-publishable documentation (such as research protocols, data collection instruments, other findings) available to internal and external bona fide researchers upon request in a timely fashion. The de-identified data will be made available to others only after discussion with the study team and under a formal data-sharing agreement that provides for: 1. commitment to use data for research purposes only and not to identify individual study participants; 2. commitment to use appropriate information technology systems to keep data secure; and 3. commitment to returning or destroying data after analyses are complete. The research team will also work with the Boston University Medical Campus Institutional Review Board (IRB) to assure protection of confidentiality, as necessary.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caroline J Kistin, MD MSc principal investigator
Brown University School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified Family Talk in people with Substance Use Disorders, run by Brown University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participation metrics (time frame: 12 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.