Institutional Review Board: Policy and Procedure Manual

Institutional Review Board

Sample Research Protocol

DESCRIPTION OF STUDY

Purpose and Potential Benefits: The Student Assistance Program (SAP) is the most popular early intervention for adolescent alcohol abuse, and preliminary data suggest that SAPs can be effective for reducing alcohol abuse in some students. However, conclusive statements about the effectiveness of SAPs cannot be made because of several methodological limitations of SAP studies performed to date. These studies have not: a) included a comparison group; b) engaged in systematic, repeated follow-up of students who take part in SAPS; or, c) evaluated students on standardized alcohol and/or other drug use measures. Furthermore, despite consistently finding that a sizable number of teens do not change their substance use in response to SAPS, studies have not examined who does or does not benefit from SAP participation or what the "active ingredients" of SAPs are.

The current study proposes to compare the effectiveness of a SAP group counseling (GC) intervention with assessment/referral-only (AR) for reducing alcohol abuse and related problems among adolescents. We will also assess the impact of depressive symptoms on substance use outcomes given evidence that depressed teens may demonstrate less response to substance abuse intervention than nondepressed teens. Finally, we will examine the impact of other potential predictor variables (i.e., alcohol expectancies, problem behaviors, social support) on substance use outcomes. Major hypotheses are: a) GC will be more effective in achieving and maintaining reductions in alcohol and other drug use among alcohol abusing adolescents than AR; b) GC will be more effective in improving academic conduct among alcohol abusing adolescents than AR; and, c) alcohol abusing adolescents with more depressive symptoms will have poorer substance use outcomes than adolescents with fewer depressive symptoms.

The results of this study will contribute significantly to the knowledge base concerning the effectiveness of school-based early interventions for adolescent alcohol abuse. Data will be obtained concerning a) the overall effectiveness of GC compared to AR and b) the "active ingredients" of GC intervention. Furthermore, the results will provide valuable new information concerning the predictors of substance use outcomes of alcohol abusing adolescents.  

Location of Study: The assessment, intervention, and data collection activities of the study will take place in senior high schools of the Broward County Public School System. All other project-related tasks will be performed at the Community Mental Health Center, Center for Psychological Studies, Nova Southeastern University.  

Dates of Study: Start Date: 1/l/97; End Date: 12/31/2001  

Subjects:  

Sample Size and Composition: Subjects in the current study will be recruited from students referred for school-based substance abuse assessment in fourteen different high schools from the Broward County, FL, School District. In the group counseling (GC) schools, two early intervention groups per year (one per semester) from each of these high schools will take part in the research. In the assessment/referral-only (AR) schools, two cohorts of subjects will take part in the study, one cohort from students referred early in the first semester for substance abuse evaluation and a second cohort from students referred early in the second semester for substance abuse evaluation.

Among public high school students referred for school-based substance abuse evaluation in Broward County, 896 were referred out for intervention or suspended for substance use-related infractions during the 1994-1995 academic year (on average, 40.7 students per high school). This group (i.e., students referred for substance abuse evaluation during the data collection phase of the project) represents the subject pool for the current study. Conservatively estimating the number of students who agree to participate in the research at five per school per semester, we expect total subject flow to be one hundred and forty (140) per year and five hundred and sixty (560) across the four years of data collection. Estimating subject attrition at 30%, we anticipate 392 subjects to remain enrolled in the study across the four data collection time points.

Based on 1994-1995 referral data, the subject sample is expected to be composed of approximately equal numbers of females and males. Furthermore, the racial/ethnic composition of the sample is expected to be predominantly white (53%), reflecting the racial/ethnic composition of the population of Broward County. Approximately 47% of subjects are expected to be non-white, most of whom will be African-American (27%) or Latino (13%).

Subject Selection and Eligibility Requirements: In the Broward County Public Schools, substance abuse services for adolescents with alcohol and/or other drug problems are limited to assessment and referral. Referral sources for these school-based assessment and referral services parallel those used in school districts with Student Assistance Programs, and include the students themselves, teachers, school counselors, and parents. Students referred for school-based substance abuse assessment form the pool from which subjects for the current study will be drawn.

Inclusion criteria for both study conditions will include: (1) alcohol abuse as identified using the Teen Addiction Severity Index (T-ASI); (2) active parental consent (see section 5.3.a. for greater detail); (3) student willingness to participate; and, (4) between 13-18 years of age. Exclusion criteria will include: (1) psychoactive substance dependence as identified using the T-ASI; (2) repeated dangerous behavior such as drinking while driving; (3) current major depression, dysthymia, or other Axis I Disorder as diagnosed using the Diagnostic Interview Schedule for Children (DISC); (4) current suicidal risk as identified using the Suicide Probability Scale; (5) significant health problems related to drinking (e.g., head injuries from falling while intoxicated, withdrawal symptoms, a significant history of blackouts); (6) pregnancy in females, as determined by self-report; (7) cognitive impairments and developmental delays as indicated by school evaluations and educational placement, and, (8) other drug abuse in the absence of alcohol use problems as identified using the T-ASI.

Exclusion criteria 1 through 6 derive from ethical obligations; the clinical needs of students meeting any of these criteria are not adequately addressed in our school-based 'intervention groups. Because these exclusion criteria represent significant clinical problems, the parent of any student who scores positive on any of the exclusion criteria will be notified Immediately of this by the research interviewer by telephone. During that telephone contact, appropriate treatment referral information will also be provided to the parent. The basic procedure followed by the research interviewer will be as follows: (1) contact parents informing them of (a) our reason for concern and (b) possible referrals for treatment, including the CMHC administered by the Center for Psychological Studies at Nova Southeastern University; (2) offer assistance to the parent in scheduling an intake appointment at whatever treatment facility the parent selects; (3) contact the parent within two days of the initial contact to ensure that an intake appointment has been scheduled; (4) on an as needed basis, contact the parent again to ensure that the parent acts promptly in getting their child appropriate treatment; and, (5) with the parent's written permission, release a written report to the treatment facility regarding our reason for concern.

Exclusion criterion 7 derives from previous clinical experience intervening with cognitively impaired and developmentally delayed adolescent substance abusers. Such students do not appear to benefit from group counseling with peers of higher cognitive functioning. As a result, a cognitively impaired or developmentally delayed student who is referred for substance abuse intervention will be referred out to individual counseling. Finally, it should be noted that all the inclusion and exclusion criteria described above (with the exception of exclusion criterion 8) are the same eligibility criteria routinely employed by Westchester Model Student Assistance Programs. Exclusion criterion 8, which is unique to the current investigation, derives from the study's primary focus on alcohol abuse rather than other drug abuse.  

Methods and Procedures:  

Overview: The current study compares the effectiveness of school-based Student Assistance Program group counseling with an assessment/referral-only condition for reducing alcohol abuse among adolescents. Group counseling (GC) subjects will participate in a 10-week, school-based group intervention and will be assessed immediately before and after intervention and at 1- and 3-month follow-up points. Comparison condition i.e., assessment/referral-only) subjects will participate in substance abuse assessment and will be offered referrals to self-help groups and local treatment providers. Assessment/referral-only (AR) subjects will be assessed on the same schedule as GC subjects to control for history effects.

Subjects will be assigned into one of the two study conditions (i.e., GC or AR). Each of the fourteen schools taking part in the study will be assigned into one of two 7-school groups equated on racial/ethnic composition of schools. Over the course of the study, each school group will participate twice in each of the two study conditions; study condition assignment will be alternated on a yearly basis across schools. Furthermore, two cohorts of subjects (one per semester) will be enrolled in the study per academic year. During any single academic year, study condition assignment will remain the same across semesters for each school.

We also plan to conduct 1-year follow-up assessments on a subsample of the subjects in order to obtain preliminary data on longer term outcomes of alcohol abusing high school students. Adolescents who participate in either condition of the study in Years 1-3 and are in grades 9-11 at study enrollment will be recruited to take part in the 1-year follow-up assessment.  

Subject Recruitment: As described earlier, the subject pool for the current study will be Broward County public high school students referred for school-based substance abuse assessment (such services are currently offered in all 22 Broward County public high school through the Division of Student Services). Following assessment by a school-based substance abuse assessment specialist, most students are either referred for outside substance abuse intervention or suspended from school for a substance use-related infraction of school code. Only these students will be eligible for the current study. The substance abuse specialist will notify parents of their child's eligibility to participate in the study and will inform parents that a research interviewer will contact them to explain the study and seek consent for their child to participate in the research. Students for whom parental consent is obtained will be screened by the research interviewer according to inclusion and exclusion criteria. Students who meet eligibility criteria will be asked to participate in the study, and informed consent will be sought from the students themselves.

To facilitate cooperation from school staff and efficient screening and evaluation of subjects, each research interviewer will be assigned to a particular school. We considered rotating interviewers across schools but ruled out such an approach given school officials' concerns about the potential disruptiveness of alternating interviewers. Other than screening and evaluation, research interviewers will have no clinical contact/responsibilities with subjects.

Students who agree to participate in the study will be assessed at the initiation and conclusion of the GC condition by the research interviewers on measures of alcohol and other drug use, depressive symptoms, and process variables (i.e., putative mechanisms of change). Measures of alcohol and other drug use and depression will also be administered by the research interviewers at I- and 3-month follow-ups. In both conditions, subjects will be evaluated on the same assessment instruments at the same time points (i.e., preintervention, postintervention [10 weeks later], and 1- and 3-month follow-ups). Furthermore, in both conditions, subjects will be offered referrals to substance abuse interventions (e.g., support groups, treatment) occurring outside of school. Referral only, without school-based intervention, is standard practice in most schools that do not have a formal substance abuse intervention program (including the Broward County Public Schools). Finally, in both conditions parents will be notified and subjects will be referred out for more intensive treatment if emergencies arise (e.g., suicidality, onset of Axis I disorder).  

The Group Counseling (GC) Condition: GC subjects will participate in a standardized version of early intervention SAP group counseling. This intervention is for students who are in the early stages of abusing alcohol and/or other drugs and are experiencing negative consequences as a result. The goal is to reduce alcohol use, with abstinence as the ideal outcome. Groups of 6 to 10 subjects will meet for ten 45-minute sessions over a 10-week period. Sessions will be led by interventionists trained especially for this project. Interventionists will be required to hold a masters degree in an area directly related to conducting psychotherapy (e.g., Masters in Social Work, Masters in Mental Health Counseling, Masters in Clinical or Counseling Psychology). Interventionists will have no project related-responsibilities other than leading the group counseling sessions and completing session-related ratings. All interventionists will receive extensive training in conducting the GC intervention from the Principal Investigator (a Clinical Psychologist recently licensed [6/96] in the State of Florida), the Co-Investigators (both Psychologists), and the project's Student Assistance Program Expert Consultant (Sarah Dinklage, MSW, a nationally-recognized SAP expert who directs Student Assistance Services for RIEAP, Inc., and who has served at the Principal Trainer for Student Assistance Program Development for the Department of Health, the State of Rhode Island). Weekly supervision of the interventionists will be provided by the Principal Investigator and the Co-Investigators. Written therapist and subject manuals will be used and followed at all times to insure standard delivery of the GC condition across group leaders, schools, and time. All GC sessions will be audiotaped and rated shortly thereafter by independent raters (not otherwise associated with intervention delivery) to assess therapist competence and adherence to the protocol. To insure confidentiality for subjects, interventionists and group participants will be instructed to use only subjects' first names during the taping of sessions, and audiotapes will be erased after they have been rated.  

The Assessment/Referral-Only (AR) Condition: AR condition subjects will receive substance abuse assessments and offered referrals to substance abuse interventions (e.g., support groups, treatment) occurring outside of school by their school counselor. In addition, they will be assessed by the research interviewers. AR condition subjects will not receive the school-based group counseling intervention administered to the GC condition subjects. However, AR condition subjects will be assessed at the same time points and with the same measures as active condition subjects. This comparison condition was chosen because of its high ecological validity. Referral only, without school-based intervention, is standard practice in most schools that do not have a formal substance abuse intervention program, as is the case in the Broward County Public Schools. Furthermore, the AR condition was designed such that the primary difference between the GC intervention and AR condition is the presence/absence of the school-based group intervention.  

Measures and Administration: Assessment will focus on seven domains: (1) background variables, including demographics and involvement in other counseling services; (2) measures of alcohol use behavior; (3) measures of DSM-III-R Axis I disorders; (4) measures of depressive symptomatology; (5) academic conduct variables; (6) process variables; (7) other potential determinants of response to intervention; and, (8) manipulation checks and internal validity measures.

Prior to intervention, research interviewers will have three separate 45-minute sessions to complete assessments on each subject. This amount of time should enable the completion of all required preintervention measures, and spreading assessment across three separate sessions should help reduce subject burden. Postintervention assessment will take place across two separate 45-minute sessions, and the relatively brief follow-up assessments will take place during single 45-minute sessions. Research interviewers will be monitored by project administrative personnel to assure timely and uniform administration of assessment measures. Interventionists will remain blind to all questionnaire data throughout all assessments. However, throughout the course of the study interventionists may notify parents and refer a student for more intensive treatment if indicated (e.g., suicidality, the emergence of an Axis-I disorder, suspicion of sexual abuse). Table 2 (pleasure refer to hardcopy version) shows the proposed measures according to scheduled administration, and two copies of the measures are included with this submission form. While we will employ a relatively extensive set of measures, we have utilized comparable assessment procedures in past studies of adolescents and adults and found that subjects are willing to comply with these assessment procedures provided the procedures are fully explained in advance of subjects' participation. Furthermore, the inclusion of a gift certificate incentive for participation will increase subjects' willingness to cooperate with the assessment procedures.  

Participant Payments or Costs: To offer incentive for study participation and reduce attrition, each subject will receive a $15 gift certificate to a local music shop, sports store, or restaurant (the subject's choice) for each assessment interview he or she completes.  

Subject Confidentiality: Confidentiality will be maintained by the numerical coding and stripping of identifying information of all data upon transfer to Nova Southeastern University. All subjects will be assigned ID numbers which will be used in place of names on all assessment materials. The list linking ID numbers with names will be maintained in locked and secure files by the Principal Investigator. Additionally, all data will be stored in locked file drawers at each stage of data transfer. Moreover, all data obtained will be accessible only to research staff, and no subject will be identified in any report of the project. All research interviewers, interventionists, and staff will be thoroughly versed in ethical issues associated with this research, with specific attention to confidentiality. The Principal Investigator, who has experience teaching graduate and post-doctoral seminars in research ethics, will train project staff in ethical issues associated with the project. He will rely upon materials including the Association of American Medical Colleges' (1994) Teaching the responsible conduct of research through a case studv approach and Bersoff's (1995) Ethical conflicts in psychology. All research interviewers, interventionists, and staff will sign a formal oath of confidentiality as part of their employment contract.

As noted earlier, GC sessions will be audiotaped to assess therapist competence and adherence to the protocol. To insure confidentiality for subjects, interventionists and group participants will be instructed to use only subjects' first names during the taping of sessions. Audiotapes will be transported by the interventionists from the schools to the project's offices at Nova Southeastern University where they will be stored in locked file drawers in the Project Coordinator's office prior to rating. The audiotapes will be accessible only to research staff participating in the competence and adherence ratings. Audiotapes will be erased immediately after they have been rated.  

Potential Risks to Subjects:  

a. Confidentiality and loss of privacy:

Likelihood: rare

Minimization: See Subject Confidentiality above.  

Risk/Benefit Ratio: The risks to subjects are judged to be minor. As part of the study, all subjects will benefit from evaluation by a research interviewer trained in the assessment of adolescent substance abuse. Furthermore, all subjects will be referred to outside providers for treatment when indicated. Group counseling intervention subjects will also benefit from participation in a school-based substance abuse early intervention group. However, it should be noted that it remains unknown whether participation in such a group results in better outcomes than assessment/referral only (hence the current study). Additionally, any subject asked to participate in the study who refuses to participate in the study at any point remains eligible to participate in the intervention group (if ongoing in their school) if he or she so desires. The anticipated knowledge benefits are great, insofar as the results will be used to evaluate the effectiveness of the school-based group counseling for adolescent alcohol use problems and to increase understanding of the relation between problematic alcohol use and depressive symptoms in adolescence.  

Consent Forms: Subjects will be recruited from high school students referred for school-based substance abuse assessment. Students for whom parental consent is obtained and who themselves consent to be in the study will constitute the research subjects. We plan to use separate consent forms for each of the two conditions of the study, as schools (not subjects) are assigned to treatment condition. Parental Consent: "Active" parental consent procedures require written or verbal consent from a parent or guardian before a minor can become involved in research, and such procedures will be used in the proposed study. The subject pool for the current study will be Broward County public high school students referred for school-based substance abuse assessment. Following assessment by a school-based substance abuse assessment specialist, most students are either referred for outside substance abuse intervention or suspended from school for a substance use-related infraction of school code. Only these students will be eligible to take part in the current study. The substance abuse specialist will notify parents of their child's eligibility to participate in the study and will inform parents that a research interviewer will contact them to explain the study and seek consent for their child to participate in the research. Next, a research interviewer will contact parents by telephone and explain to them the nature of the study and their child's involvement in the study. At that time, verbal parental consent for their child's participation in the study will be sought, and the research interviewer will complete a Parental Telephone Consent Form. In addition, parents will be mailed two copies of a Parental Consent Form, one of which is signed by the parent and returned via postage-paid business reply mail (see attached Consent Forms). The Telephone Consent Form and the returned Parental Consent Form will be filed together and stored in locked file cabinets in the project's offices. Students for whom parental consent is obtained will be screened by the research interviewer according to inclusion and exclusion criteria. Students who meet eligibility criteria will be asked to participate in the study, and informed consent will be sought from the students themselves.  

Student Consent: In addition, adolescent subjects' informed consent will be obtained by the research interviewers prior to being enrolled in the study (see attached Consent Forms). Students who agree to participate in the study will consent to take part in four assessment interviews. A subsample of students (described earlier) will be recruited at the 3-month assessment point to participate in a 1-year follow-up assessment. Parallel procedures as those used in obtaining initial parental consent (i.e., telephone contact followed by a mailing) will be used. Separate informed consent for the 1-year follow-up assessment will be obtained by the research interviewers from both the parents and the students themselves (see attached Consent Forms).

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