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Preventing Youth Substance Use With Family Talk

Primary Purpose

Substance Use Disorders

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Family Talk
Sponsored by
Boston Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Substance Use Disorders focused on measuring parent-youth dyads, modules, prevention of adolescent SUD (substance use disorder), Family Talk

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Youth-Parent Dyads

    Arm Description

    Participants will receive the Family Talk intervention and followup.

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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.
    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.
    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.
    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.

    Secondary Outcome Measures

    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.

    Full Information

    First Posted
    May 19, 2020
    Last Updated
    July 11, 2022
    Sponsor
    Boston Medical Center
    Collaborators
    National Institute on Drug Abuse (NIDA)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04400227
    Brief Title
    Preventing Youth Substance Use With Family Talk
    Official Title
    Pilot Study of Family Talk to Prevent Youth Substance Use
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2022
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Study closed due to change in funding.
    Study Start Date
    July 2022 (Anticipated)
    Primary Completion Date
    June 2023 (Anticipated)
    Study Completion Date
    June 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Boston Medical Center
    Collaborators
    National Institute on Drug Abuse (NIDA)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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. 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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Substance Use Disorders
    Keywords
    parent-youth dyads, modules, prevention of adolescent SUD (substance use disorder), Family Talk

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Youth-Parent Dyads
    Arm Type
    Experimental
    Arm Description
    Participants will receive the Family Talk intervention and followup.
    Intervention Type
    Other
    Intervention Name(s)
    Family Talk
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Change in youth substance use based on the Timeline Followback Interview
    Description
    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.
    Time Frame
    baseline, 6 months
    Title
    Youth substance use based on the Timeline Followback Interview at 2 months
    Description
    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.
    Time Frame
    2 months
    Title
    Youth substance use based on the Timeline Followback Interview at 4 months
    Description
    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.
    Time Frame
    4 months
    Title
    Change in Youth substance use based on the Screening to Brief Intervention Tool
    Description
    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.
    Time Frame
    baseline, 6 months
    Title
    Youth substance use based on the Screening to Brief Intervention Tool at 2 months
    Description
    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.
    Time Frame
    2 months
    Title
    Youth substance use based on the Screening to Brief Intervention Tool at 4 months
    Description
    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.
    Time Frame
    4 months
    Secondary Outcome Measure Information:
    Title
    Family Functioning based on the Family Problem Solving Communication Index
    Description
    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.
    Time Frame
    baseline, 2, 4, 6 months
    Title
    Family Functioning based on the Inventory of Parent and Peer Attachment
    Description
    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.
    Time Frame
    baseline, 2, 4, 6 months
    Title
    Depression
    Description
    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.
    Time Frame
    baseline, 2, 4, 6 months
    Title
    Perceived Stress
    Description
    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.
    Time Frame
    baseline, 2, 4, 6 months
    Title
    Problem Solving
    Description
    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.
    Time Frame
    baseline, 2, 4, 6 months
    Title
    Coping based on the Coping Self-Efficacy Scale
    Description
    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.
    Time Frame
    baseline, 2, 4, 6 months
    Title
    Coping based on the Brief COPE
    Description
    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.
    Time Frame
    baseline, 2, 4, 6 months
    Title
    Social support
    Description
    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.
    Time Frame
    baseline, 2, 4, 6 months
    Title
    Stressful Life Events
    Description
    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.
    Time Frame
    baseline, 2, 4, 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Caroline Kistin, MD MSc
    Organizational Affiliation
    Boston Medical Center
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Scott Hadland, MD
    Organizational Affiliation
    Massachusetts General Hospital
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Preventing Youth Substance Use With Family Talk

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