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Patient
Information
Brief Strategic Family Therapy for Adolescent Drug
Abusers
A research study involving the family
(pdf version)
You have taken the first important step to recovery
of your drug addiction by coming into treatment, and you want to make
the most of it. By joining this research study, you may be able to
further benefit from your current treatment and could also help counselors
find out how to best help other women like yourself.
Description of the Study
As many as 80% of women seeking treatment for drug abuse
have experienced either sexual or physical assault. These experiences
often lead to nightmares, an inability to stop thinking about the
event, feeling numb, being easily frightened and jumpy, or feeling
depressed, worried, or hopeless. These are just a few signs of a condition
known as posttraumatic stress disorder (PTSD).
This study will compare two different interventions
designed specifically for women: Seeking Safety
and Women’s Health Education. These
interventions will be in addition to the usual treatment provided
at your treatment program. We are studying these groups to see how
well they help women 1) reduce their substance use, stress, and other
emotional problems and 2) increase their treatment attendance. This
study is being conducted at several sites across the United States.
About 480 women will be enrolled nationwide, including about 60 volunteers
at your treatment program.
If You Decide To Join
Your participation in this study is completely voluntary
— you may refuse to participate or stop participating any time.
If you choose not to take part, your relationship with your current
treatment provider will not be affected in any way nor will your right
to health care and other services. You are encouraged to ask as many
questions as you want to help you decide if you want to join the study.
If you do decide to participate, this is what you can expect:
You will be asked to complete a screening interview
that will include questions about your mental health, physical health,
and drug use. Before this interview, the purpose of the screening
will be fully explained to you and you will be asked for your written
consent (agreement) to participate. This interview will be used to
determine if you are eligible for the study. If you are eligible,
the study will be described to you in more detail and you will be
asked to complete a second interview.
- After being accepted into the study you will have an equal chance
of being assigned to one of the two women’s groups. The study
groups are in addition to the usual care you receive at your treatment
program.
- Once you begin treatment, you will attend the intervention two
times each week for six weeks (a total of 12 groups). Each group
session will last for 90 minutes. There will be 2-7 other women
in the group, some of whom may have backgrounds and experiences
similar to yours.
- Each week, you will be asked to complete some forms about your
experiences in the group as well as your mental health and substance
use. You will also be asked for a urine and a saliva sample (for
drug and alcohol screening) at this visit.
- At the end of the 6 weeks, you will be interviewed for approximately
2 hours. You will be contacted to complete this interview again
3, 6 and 12 months after the study group ends, whether or not you
are still enrolled in the treatment program.
- All of the information that you give us, including urine test
results, will be kept confidential. The staff will explain the details
of confidentiality to you.
Frequently Asked Questions
1. What happens if I miss a session?
If you are hospitalized or miss more than four therapy
sessions in a row, you may no longer be eligible for the study.
However, if you are taken out of the study or choose to leave the
study, you can still continue in your regular treatment program.
2. How long will I be in the study?
The study includes 6 weeks of twice weekly group therapy
and follow-up assessments at 1 week, 3 months, 6 months, and 12
months. Therefore, you will be in the study for approximately 14
months.
3. What will I have to do during the study?
If you do want to participate, you will:
- Complete a screening interview.
- If eligible, complete a second interview.
- Attend study treatment sessions for approximately 6 weeks in
addition to your regular treatment.
- Fill out questionnaires and give saliva and urine samples.
- Return for four study follow-up visits.
4. What happens at study follow-up visits?
Study visits include questions about:
- Your health and how you are feeling.
- Drugs you are taking.
- How you are doing in your life (family/social, legal, employment,
etc.).
5. What are the benefits of being in the study?
You may or may not benefit personally from participating
in this study. Investigators may find out which, if any, of the
groups are most useful for treating other women who have histories
of trauma and abuse substances. This may provide a powerful benefit
to many women like you.
6. Are there any negative effects from taking part
in the study?
Psychotherapy, interviews, assessments, and urine
collection pose limited risks. You may become uncomfortable while
being asked personal questions, but the interviewers and counselors
are trained to recognize this and to provide support.
For more information
For more information on the National Drug Abuse Treatment
Clinical Trials Network, visit the NIDA website at www.drugabuse.gov.
For information on other clinical trials, the National
Institutes of Health (NIH) has created a website to help patients,
family members, and the general public obtain information about government-sponsored
clinical trials. You may log on to www.Clinicaltrials.gov
to learn about ongoing or new trials for all types of health-related
conditions. The descriptions for individual trials include eligibility
criteria, purpose of the trial, location, and how to apply if interested.
The website is maintained and updated regularly by the National Library
of Medicine.
National Institute on Drug Abuse
Center for Clinical Trials Network
6001 Executive Boulevard
Room 4234, MSC 9557
Bethesda, Maryland 20892-9557
Telephone: (301) 443-6697
Fax: (301) 443-2317
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