Substance Use DisordersNCT04400227
Preventing Youth Substance Use With Family Talk
A study testing Family Talk in people with Substance Use Disorders, run by Boston Medical Center.
Trial summary
Family Talk, an evidence-based parent-youth dyadic intervention, is a promising approach to improving substance use outcomes for high-risk families, and its structure lends itself to delivery by existing personnel within an Office-Based Addiction Treatment (OBAT) model of care. 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?
- Family Talk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2022to Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Participating parent is receiving treatment for substance use disorder
- Participating youth is between the ages of 12-25
- Participating youth has no diagnosis of substance use disorder
- Parent and youth are both comfortable communicating in English or Spanish
Who cannot join
- Acute family crisis, such as recent or current incarceration, divorce, adult return to substance use, or traumatic event
- Adult or youth with cognitive limitation or intellectual disability
About this study
Official title: Pilot Study of Family Talk to Prevent Youth Substance Use
Family Talk, an evidence-based parent-youth dyadic intervention, is a promising approach to improving substance use outcomes for high-risk families, and its structure lends itself to delivery by existing personnel within an Office-Based Addiction Treatment (OBAT) model of care. The investigators propose a single-arm pilot study with 25 parent-youth dyads through which a rapid cycle performance improvement approach will be employed to adapt and optimize the content and delivery of the embedded Family Talk prevention strategy. The investigators will field-test relevant baseline and outcome measures and will use qualitative methodology to identify key modifications to the intervention and generate hypotheses for how the prevention strategy may impact youth and family outcomes and prevent youth substance use. Information from this study will inform a subsequent pilot randomized controlled trial of the intervention to prevent substance use for youth whose parents are in recovery from SUD (substance use disorder).
- Conditions
- Substance Use Disorders
- Being tested
- Family Talk
- Keywords
- parent-youth dyads, modules, prevention of adolescent SUD (substance use disorder), Family Talk
- 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.
Family TalkOther
Family Talk is an evidence-based, parent-youth dyadic approach that uses psychoeducation and skills building to help families make meaning of a parent's adversity, increase resilience, and improve family functioning.
The Family Talk model comprises two components: the first involves a series of cognitive-behavioral techniques to bolster problem solving and communication skills among family members; the second involves a facilitated family meeting to develop a shared narrative for discussing each family member's experience of the parent's illness.
| Study group | Role | What they receive |
|---|---|---|
| Youth-Parent Dyads | Experimental | Participants will receive the Family Talk intervention and followup. Receives: Other: Family Talk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in youth substance use based on the Timeline Followback Interview
The Timeline Followback Interview (TLFB) will be used to estimate substance use. It uses a calendar and asks the participant to indicate whether they used substances on each of the days listed for the last 3 months. No score is given for the measure. However, more days of use is associated with adverse health outcomes.
Measured: baseline, 6 months
Youth substance use based on the Timeline Followback Interview at 2 months
The Timeline Followback Interview (TLFB) will be used to estimate substance use. It uses a calendar and asks the participant to indicate whether they used substances on each of the days listed for the last 3 months. No score is given for the measure. However, more days of use is associated with adverse health outcomes.
Measured: 2 months
Youth substance use based on the Timeline Followback Interview at 4 months
The Timeline Followback Interview (TLFB) will be used to estimate substance use. It uses a calendar and asks the participant to indicate whether they used substances on each of the days listed for the last 3 months. No score is given for the measure. However, more days of use is associated with adverse health outcomes.
Measured: 4 months
Change in Youth substance use based on the Screening to Brief Intervention Tool
The Screening to Brief Intervention instrument, or S2BI, is a 7-item instrument that asks about tobacco, alcohol, marijuana, prescribed drugs, inhalants, illegal drugs, and herbs/synthetic drugs. Responses for each substance can be 'never', 'once or twice', 'monthly', of 'weekly or more'. The result range from "no reported use," "lower risk," or "higher risk." For the lower and higher risk categories the intervention provides guidance for developing an action plan for each response category.
Measured: baseline, 6 months
Youth substance use based on the Screening to Brief Intervention Tool at 2 months
The Screening to Brief Intervention instrument, or S2BI, is a 7-item instrument that asks about tobacco, alcohol, marijuana, prescribed drugs, inhalants, illegal drugs, and herbs/synthetic drugs. Responses for each substance can be 'never', 'once or twice', 'monthly', of 'weekly or more'. The result range from "no reported use," "lower risk," or "higher risk." For the lower and higher risk categories the intervention provides guidance for developing an action plan for each response category.
Measured: 2 months
Youth substance use based on the Screening to Brief Intervention Tool at 4 months
The Screening to Brief Intervention instrument, or S2BI, is a 7-item instrument that asks about tobacco, alcohol, marijuana, prescribed drugs, inhalants, illegal drugs, and herbs/synthetic drugs. Responses for each substance can be 'never', 'once or twice', 'monthly', of 'weekly or more'. The result range from "no reported use," "lower risk," or "higher risk." For the lower and higher risk categories the intervention provides guidance for developing an action plan for each response category.
Measured: 4 months
Secondary outcomes (9)
Family Functioning based on the Family Problem Solving Communication Index
The Family Problem Solving Communication (FPSC) Index is a 10-item questionnaire designed to assess both positive and negative patterns of family communication. Answer choices are on a 4-point scale (0 = False, 1 = Mostly False, 2 = Mostly True and 3 = True). The two subscales can be scored separately, with Incendiary Communication measuring negative attributes and Affirmative Communication measuring positive forms of communication.
Measured: baseline, 2, 4, 6 months
Family Functioning based on the Inventory of Parent and Peer Attachment
Inventory of Parent and Peer Attachment (IPPA) is a validated questionnaire that consists of 25 items for the mother, 25 items for the father, and 25 items for the adolescent. Three broad dimensions are assessed: degree of mutual trust, quality of communication, and extent of anger and alienation. Answers are rated on a 5-point Likert scale from 1 (almost never or never) to 5 (almost always or always). The IPPA is scored by reverse-scoring the negatively worded items and then summing the response values in each section.
Measured: baseline, 2, 4, 6 months
Depression
Quick Inventory of Depressive Symptomatology is a 16-item questionnaire that measures rates of depression symptoms. Each answer in the survey is worth between 0 and 3 points. Severity of depression can be judged based on the total score. 1-5 = No depression 6-10 = Mild depression 11-15 = Moderate depression 16-20 = Severe depression 21-27 = Very severe depression.
Measured: baseline, 2, 4, 6 months
Perceived Stress
Perceived Stress Scale (PSS) is a 10-item psychological instrument for measuring the perception of stress. Answer choices range from 0 to 4 (0=Never and 4=Very Often). PSS scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 \& 4 = 0) to the four positively stated items (items 4, 5, 7, \& 8) and then summing across all scale items with higher scores indicating higher levels of stress.
Measured: baseline, 2, 4, 6 months
Problem Solving
The Social Problem-Solving Inventory - Revised (SPSI-R) has both a long form (52 questions) and short form (25 questions) and assesses individual's strengths and weaknesses in their problem-solving abilities. The inventory has five component scales to assess problem-solving styles and solution generation: Positive Problem Orientation, Negative Problem Orientation, Rational Problem Solving, Impulsivity/Carelessness Style, Avoidance Style.
Measured: baseline, 2, 4, 6 months
Coping based on the Coping Self-Efficacy Scale
The Coping Self-Efficacy Scale (CSES) is a 26-item measure of perceived self-efficacy for coping with challenges and threats. The answer choices are a rating on an 11-point scale. Anchor points on the scale are 0 ('cannot do at all'), 5 ('moderately certain can do') and 10 ('certain can do'). An overall CSES score is created by summing the item ratings with high scores indicate greater coping skills.
Measured: baseline, 2, 4, 6 months
Coping based on the Brief COPE
The Brief COPE is a 28-item multidimensional measure of strategies used for coping or regulating cognitions in response to stressors. There are 14 two-item subscales within the Brief COPE, and each is analyzed separately: (1) self-distraction, (2) active coping, (3) denial, (4) substance use, (5) use of emotional support, (6) use of instrumental support, (7) behavioral disengagement, (8) venting, (9) positive reframing, (10) planning, (11) humor, (12) acceptance, (13) religion, and (14) self-blame. 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 of the 14 scales is comprised of 2 items; total scores on each scale range from 2 (minimum) to 8 (maximum). Higher scores indicate increased utilization of that specific coping strategy.
Measured: baseline, 2, 4, 6 months
Social support
The Social Adjustment Scale-Self-Report (SAS-SR) 54-item measure that evaluates the efficacy of pharmacological treatments of mental disorders to provide an understanding of a client's satisfaction with his or her social situation. Answer choices are on a 5-point Likert scale with higher scores indicating a better quality of life.
Measured: baseline, 2, 4, 6 months
Stressful Life Events
The Stressful Life Events Screening Questionnaire (SLESQ) is a 13-item self-report measure that assesses lifetime exposure to traumatic events. For each event, respondents are asked to indicate whether the event occurred ("yes" or "no"), their age at time of the event, as well as other specific items related to the event, such as the frequency, duration, whether anyone died, or was hospitalization, etc. No score is given for the measure.
Measured: baseline, 2, 4, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2020
- Study startJul 2022 (estimated)
- Primary completionJun 2023 (estimated)
- Study completionJun 2023 (estimated)
Why it stopped: Study closed due to change in funding.
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 Boston Medical CenterThe 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Caroline Kistin, MD MSc, Principal investigator, Boston Medical CenterScott Hadland, MD, Study director, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04400227
- Sponsor's protocol ID
- H-38895
- Other IDs
- K23DA045085
- Status last verified
- Jul 2022
- First submitted
- 19 May 2020
- Last updated
- 13 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Family Talk to Prevent Youth Substance Use
- ClinicalTrials.gov ID
- NCT04400227
- Acronym / sponsor ID
- H-38895
- Conditions
- Substance Use Disorders
- Keywords
- parent-youth dyads, modules, prevention of adolescent SUD (substance use disorder), Family Talk
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study closed due to change in funding.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jul 2022 (estimated)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 22 May 2020 (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.
Family Talk, an evidence-based parent-youth dyadic intervention, is a promising approach to improving substance use outcomes for high-risk families, and its structure lends itself to delivery by existing personnel within an Office-Based Addiction Treatment (OBAT) model of care. The investigators propose a single-arm pilot study with 25 parent-youth dyads through which a rapid cycle performance improvement approach will be employed to adapt and optimize the content and delivery of the embedded Family Talk prevention strategy. The investigators will field-test relevant baseline and outcome measures and will use qualitative methodology to identify key modifications to the intervention and generate hypotheses for how the prevention strategy may impact youth and family outcomes and prevent youth substance use. Information from this study will inform a subsequent pilot randomized controlled trial of the intervention to prevent substance use for youth whose parents are in recovery from SUD (substance use disorder).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Youth-Parent Dyads | Experimental | Other: Family TalkParticipants will receive the Family Talk intervention and followup. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Participating parent is receiving treatment for substance use disorder
- Participating youth is between the ages of 12-25
- Participating youth has no diagnosis of substance use disorder
- Parent and youth are both comfortable communicating in English or Spanish
Key exclusion criteria (2 listed)
- Acute family crisis, such as recent or current incarceration, divorce, adult return to substance use, or traumatic event
- Adult 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 |
|---|---|---|
| Family TalkFamily Talk is an evidence-based, parent-youth dyadic approach that uses psychoeducation and skills building to help families make meaning of a parent's adversity, increase resilience, and improve family functioning. The Family Talk model comprises two components: the first involves a series of cognitive-behavioral techniques to bolster problem solving and communication skills among family members; the second involves a facilitated family meeting to develop a shared narrative for discussing each family member's experience of the parent's illness. | Other | Youth-Parent Dyads |
Primary outcome
Change in youth substance use based on the Timeline Followback Interview
Time frame: baseline, 6 months
The Timeline Followback Interview (TLFB) will be used to estimate substance use. It uses a calendar and asks the participant to indicate whether they used substances on each of the days listed for the last 3 months. No score is given for the measure. However, more days of use is associated with adverse health outcomes.
Youth substance use based on the Timeline Followback Interview at 2 months
Time frame: 2 months
The Timeline Followback Interview (TLFB) will be used to estimate substance use. It uses a calendar and asks the participant to indicate whether they used substances on each of the days listed for the last 3 months. No score is given for the measure. However, more days of use is associated with adverse health outcomes.
Youth substance use based on the Timeline Followback Interview at 4 months
Time frame: 4 months
The Timeline Followback Interview (TLFB) will be used to estimate substance use. It uses a calendar and asks the participant to indicate whether they used substances on each of the days listed for the last 3 months. No score is given for the measure. However, more days of use is associated with adverse health outcomes.
Change in Youth substance use based on the Screening to Brief Intervention Tool
Time frame: baseline, 6 months
The Screening to Brief Intervention instrument, or S2BI, is a 7-item instrument that asks about tobacco, alcohol, marijuana, prescribed drugs, inhalants, illegal drugs, and herbs/synthetic drugs. Responses for each substance can be 'never', 'once or twice', 'monthly', of 'weekly or more'. The result range from "no reported use," "lower risk," or "higher risk." For the lower and higher risk categories the intervention provides guidance for developing an action plan for each response category.
Youth substance use based on the Screening to Brief Intervention Tool at 2 months
Time frame: 2 months
The Screening to Brief Intervention instrument, or S2BI, is a 7-item instrument that asks about tobacco, alcohol, marijuana, prescribed drugs, inhalants, illegal drugs, and herbs/synthetic drugs. Responses for each substance can be 'never', 'once or twice', 'monthly', of 'weekly or more'. The result range from "no reported use," "lower risk," or "higher risk." For the lower and higher risk categories the intervention provides guidance for developing an action plan for each response category.
Youth substance use based on the Screening to Brief Intervention Tool at 4 months
Time frame: 4 months
The Screening to Brief Intervention instrument, or S2BI, is a 7-item instrument that asks about tobacco, alcohol, marijuana, prescribed drugs, inhalants, illegal drugs, and herbs/synthetic drugs. Responses for each substance can be 'never', 'once or twice', 'monthly', of 'weekly or more'. The result range from "no reported use," "lower risk," or "higher risk." For the lower and higher risk categories the intervention provides guidance for developing an action plan for each response category.
9 secondary outcomes
Family Functioning based on the Family Problem Solving Communication Index
Time frame: baseline, 2, 4, 6 months
Family Functioning based on the Inventory of Parent and Peer Attachment
Time frame: baseline, 2, 4, 6 months
Depression
Time frame: baseline, 2, 4, 6 months
Perceived Stress
Time frame: baseline, 2, 4, 6 months
Problem Solving
Time frame: baseline, 2, 4, 6 months
Coping based on the Coping Self-Efficacy Scale
Time frame: baseline, 2, 4, 6 months
Coping based on the Brief COPE
Time frame: baseline, 2, 4, 6 months
Social support
Time frame: baseline, 2, 4, 6 months
Stressful Life Events
Time frame: baseline, 2, 4, 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2022.
- Individual participant dataSharing planned: No
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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 Kistin, MD MSc principal investigator
Boston Medical Center
Scott Hadland, MD study director
Massachusetts General Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Family Talk in people with Substance Use Disorders, run by Boston Medical Center.
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 4 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: withdrawn, as of the sponsor's last update on 13 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Change in youth substance use based on the Timeline Followback Interview (time frame: baseline, 6 months). The study lists 6 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 13 Jul 2022.