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Draft Research Plan

Draft Research Plan for Illicit and Nonmedical Prescription Drug Use in Children and Adolescents: Interventions

This opportunity for public comment expires on June 6, 2018 at 8:00 PM EST

Note: This is a Draft Research Plan. This draft is distributed solely for the purpose of receiving public input. It has not been disseminated otherwise by the USPSTF. The final Research Plan will be used to guide a systematic review of the evidence by researchers at an Evidence-based Practice Center. The resulting Evidence Review will form the basis of the USPSTF Recommendation Statement on this topic.

Recommendations made by the USPSTF are independent of the U.S. government. They should not be construed as an official position of the Agency for Healthcare Research and Quality or the U.S. Department of Health and Human Services.

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Draft: Proposed Analytic Framework

Figure 1 is the analytic framework that depicts the three Key Questions to be addressed in the systematic review. The figure illustrates how interventions among children and adolescents who do or do not already use drugs may result in improved health outcomes (Key Question 1) and behavioral outcomes including drub abstinence and frequency or quantity of drug use (Key Question 2).  Additionally, the figure addresses whether interventions to reduce drug use among children and adolescents result in any harms (Key Question 3).

Draft: Proposed Key Questions to Be Systematically Reviewed

  1. Do primary care interventions to prevent or reduce drug use in children and adolescents improve health outcomes or other related outcomes?
  2. Do primary care interventions to prevent or reduce drug use in children and adolescents improve drug use outcomes?
  3. What are the harms of primary care interventions to prevent or reduce drug use in children and adolescents?

Draft: Proposed Research Approach

The proposed Research Approach identifies the study characteristics and criteria that the Evidence-based Practice Center will use to search for publications and to determine whether identified studies should be included or excluded from the Evidence Review. Criteria are overarching as well as specific to each of the key questions (KQs).

  Include Exclude
Aim Preventing and/or reducing drug use is a primary aim, with or without addressing other substances or behaviors (e.g., addressing drug use and alcohol and tobacco use, addressing drug use and risky sexual behaviors) Targeting another behavior is the only study aim (e.g., alcohol misuse, tobacco use); that is, change in drug use is not a stated aim but is a reported outcome
Condition Use of the following drugs, defined as any drug use that can result in poor health consequences, including meeting criteria for a drug use disorder:
  • Cannabinoids (marijuana, hashish, synthetic marijuana)
  • Club drugs (3,4-methylenedioxymethamphetamine [MDMA or ecstasy], flunitrazepam [Rohypnol], gamma-hydroxybutyrate [GHB], synthetic cathinone [bath salts])
  • Dissociative drugs (ketamine, phencyclidine [PCP] and analogs, Salvia divinorum [salvia], dextromethorphan [DXM])
  • Hallucinogens (lysergic acid diethylamide [LSD or acid], N,N-dimethyltryptamine [DMT], mescaline, psilocybin)
  • Inhalants (also known as volatile substances)
  • Illicit opioids (heroin, opium, Mitragyna speciosa [kratom], illicitly manufactured fentanyl [IMF])
  • Stimulants (cocaine, amphetamine, Catha edulis [khat], methamphetamine)
  • Prescription opioid pain relievers
  • Prescription sedatives (barbiturates, benzodiazepines, sleep medications)
  • Prescription stimulants
  • Over-the-counter drugs (e.g., DXM)
  • Combination of any of the above
  • Medical use of drugs as prescribed
  • Nonpsychoactive drugs (e.g., anabolic steroids, laxatives, aspirin)
Population Children and adolescents (age ≤25 years), including pregnant females
  • Older adolescents and adults (age >18 years) who currently use drugs
  • Trials limited to young persons diagnosed as having drug abuse or dependence (DSM-IV-TR) or a drug use disorder (DSM-5)
  • Children and adolescents seeking treatment
  • Children and adolescents who are referred to treatment by the juvenile justice system, a social or health agency, or their parents, or otherwise directly referred for substance abuse treatment in a specialty setting
  • Trials limited to young persons with health issues (e.g., schizophrenia, HIV) that would limit generalizability to general primary care patients
Interventions
  • Counseling interventions designed to prevent and/or reduce drug use, with or without referral
  • Counseling interventions can vary in their approach (e.g., 12-step programs, cognitive behavioral therapy, motivational enhancement therapy), specific strategies (e.g., action plans, diaries), delivery method (e.g., in person, electronic, individual, group-based), length of contact (e.g., brief, extended), and number of contacts (e.g., single, multiple)
  • Interventions targeting parents or caregivers to prevent and/or reduce drug use in young persons
  • Detoxification, medically managed withdrawal, or opioid substitution therapy (methadone maintenance programs)
  • Maintaining abstinence after substance use treatment for dependence or drug use disorder (i.e., secondary abstinence)
  • Broad public health, media, or policy interventions
  • Inpatient/residential treatment
  • Contingency management/vouchers
  • Vocational rehabilitation/customized employment supports
  • Outward Bound/life skills training
Comparators
  • No intervention
  • Usual care
  • Waitlist
  • Attention control (e.g., intervention is similar in format and intensity but on a different content area)
  • Minimal intervention (no more than one brief contact [i.e., <5 minutes] per year or brief written materials, such as pamphlets)
Active intervention (i.e., more than one brief contact per year or brief written materials)
Outcomes KQ 1 (health, social, educational, and other outcomes):

Health outcomes:

  • All-cause mortality
  • Drug-related mortality (intentional and unintentional)
  • Drug-related morbidity (including but not limited to: mental health disorders; STI/HIV transmission; hepatitis B or C virus transmission; unintended pregnancy/pregnancy complications; respiratory infections; cardiovascular complications; stroke; seizures)
  • Drug-related injury or accidents
  • Nonfatal overdose
  • Quality of life
  • Other drug-related consequences

Social, educational, or other outcomes:

  • Health care utilization
  • Global functioning
  • Educational attainment/school performance
  • Social/legal outcomes (e.g., incarcerations, out-of-home juvenile placements, criminal activity, violence, drugged driving)
  • Family functioning
  • Other related social or educational outcomes

KQ 2 (behavioral outcomes):

  • Drug use (required) (self-reported and/or biologic measures):
    • Abstinence (use/no use)
    • Frequency and/or quantity of use
    • Severity of drug use disorder (reported as an index measured by a standardized questionnaire, such as the Short Inventory of Problems, Addiction Severity Index, or Severity of Dependence Scale)
    • Composite substance use outcome
    • Other risky behaviors (e.g., alcohol, tobacco, or other drug use; risky sexual behaviors)

KQ 3 (adverse events):

  • Serious treatment-related harms at any time point after the intervention began (e.g., death (including suicide), seizure, cardiovascular event, or other medical issue requiring urgent medical treatment)
  • Demoralization due to failed quit attempt
  • Breach of confidentiality
  • Attitudes, knowledge, or beliefs related to drug use
  • Intention to change behavior
  • Intervention participation/compliance
Outcome assessment timing At least 3 months after baseline measurement (except for studies in pregnant women, for which shorter length of follow-up will be included) Less than 3 months after baseline measurement
Setting
  • Primary care settings
  • Other primary care–relevant settings, including other health care clinics, emergency departments, research clinics/offices, school health clinics, community centers, homes, and virtual settings (e.g., online support groups)
  • Substance abuse treatment centers
  • School classrooms
  • Worksites
  • Inpatient/residential settings
  • Other institutions (e.g., juvenile detention facility)
Study design
  • Randomized, controlled trials
  • Cluster-randomized, controlled trials
  • Nonrandomized, controlled trials
  • Prospective or retrospective cohort studies
  • Case-control studies
  • Time series studies
  • Before-after studies
  • Cross-sectional studies
  • Editorials, commentaries, case studies, case series
Study geography Studies conducted in countries categorized as “Very High” on the Human Development Index (based on 2015 indicators) Studies conducted in countries not categorized as “Very High” on the Human Development Index (based on 2015 indicators)
Publication language English Languages other than English
Quality rating Fair- or good-quality studies Poor-quality studies (according to design-specific USPSTF criteria)

Abbreviations: DSM = Diagnostic and Statistical Manual of Mental Disorders; STI = sexually transmitted infection.

Current as of: May 2018

Internet Citation: Draft Research Plan: Illicit and Nonmedical Prescription Drug Use in Children and Adolescents: Interventions. U.S. Preventive Services Task Force. May 2018.
https://www.uspreventiveservicestaskforce.org/Page/Document/draft-research-plan/illicit-and-nonmedical-prescription-drug-use-in-children-and-adolescents-interventions

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