Parental Permission Form. TITLE OF PROJECT: Treating Specific Phobias in Children with ADHD: Adaptation of the One-Session Treatment

Transcription

1 College of Science Child Study Center Department of Psychology 460 Turner Street, Suite 207 (0293) Blacksburg, Virginia / Fax: 540/ Parental Permission Form TITLE OF PROJECT: Treating Specific Phobias in Children with ADHD: Adaptation of the One-Session Treatment INVESTIGATORS: Thomas H. Ollendick, Ph.D. and Thorhildur Halldorsdottir, M.S. 1. PURPOSE OF THE PROJECT Your child is invited to participate in a research study that will determine how well a modified treatment of specific phobias works for children who also have Attention-Deficit/Hyperactivity Disorder (ADHD). ADHD is characterized by age-inappropriate inattention, hyperactivity and impulsivity. Many children with ADHD are also anxious. However, there is some indication that youth with ADHD may not benefit from effective treatments for anxiety disorders as those without ADHD. Specific phobias are a type of anxiety disorder. A phobia can be defined as a fear that is both excessive and unreasonable. The fear is usually brought on by seeing or experiencing a specific object, event, or situation (e.g., animals, heights, thunderstorms) or by the expectation that the feared object or situation may be present. Phobias can last a long time and are not usually healthy because they lead the child to avoid the object or situation that he/she fears. For many children and their parents, phobias are highly disruptive. Of course, parents may also possess phobias, and their phobias may either be the same as that of their children or different. This project will examine a modified treatment for specific phobias tailored to the needs of youth with ADHD. The treatment that has been modified is called the One-Session Exposure Treatment a treatment based on work recently completed by us in an earlier project funded by the National Institute of Mental Health. The treatment is called One-Session Exposure Treatment because it is delivered in one long session, lasting up to 3 hours in duration. The treatment is thought to work because the child is taught a number of skills to deal with the feared situation. These skills include both cognitive (thoughts) and behavioral (action) skills to aid the child in approaching the feared object or situation. In addition, during treatment, the child is exposed gradually to the feared situation in a highly structured, safe, and controlled manner. The primary purpose of the study is to determine whether the One-Session Treatment works for youth with ADHD. In total, nine boys and girls between the ages of 8 to 12 years old will participate in this study. 2. PROCEDURE TO BE FOLLOWED IN THE STUDY: In order to determine whether the treatment is effective, your child will be asked to complete some questionnaires, as well as a structured diagnostic interview prior to the beginning of treatment, following treatment, and at 1 month, and 6 month. The diagnostic interview is a type of clinical interview and will tell us whether your child has a clinical level of ADHD and a specific phobia. More specifically, your child will be asked questions about his or her difficulty Invent the Future

2 with ADHD-like behaviors and what he or she does when faced with his or her phobia and what the phobia is like for the family. During the diagnostic interview, your child will also be asked about psychological problems other than his or her ADHD and specific phobia. For example, some children might also worry excessively or feel depressed. Your child will also be asked to complete a short task with numbers. In addition, your child will be asked to complete behavioral avoidance tests to measure how much your child stays away from the thing that produces the fear. For example, if your child is afraid of dogs, he or she will be asked to approach a dog in a room and to rate how fearful he or she feels during this test. Of course, your child will not be asked to do anything he or she does not wish to do or is not ready to do. Your child can stop this test at any time. You will also be asked to do this test with the child so that we can see how your child does with the feared object when you are present with. After the initial session, you and your child will come in for what is called a Functional Analysis. During this time, you and your child will be asked detailed questions about your child s phobia in order to inform appropriate treatment activities. Then your child will be randomized to a baseline phase with a duration of 2, 3, or 4 weeks. During this phase, your child will be asked to complete measures regarding his or her fear of the phobic object/situation and the numbers task via phone once a week. This baseline phase is designed to assess fear levels prior to receiving treatment which will then be compared to how your child is doing after treatment to determine the effectiveness of the treatment. Following the baseline phase, you and your child will come in for the treatment session at Virginia Tech which will be approximately 3 hours in duration (see description above for more details). After treatment, we will ask your child to keep a diary of how things are going for the first month following treatment and a clinician will call your child to administer the number task on a weekly basis for 4 weeks. Also, we will ask you and your child to return to the clinic for 2- hour assessment sessions after 1 week, 1 month, and 6 months so that we can assess how things are going. Similar to the first session, in order to determine whether the treatment is effective, your child will be asked to complete some questionnaires, a diagnostic interview and the numbers task one week following treatment and at 1 month, and 6 month follow-ups All sessions you and your child attend at the clinic will be videotaped. Videotaping is done to document that our interviewers and therapists carefully followed the research protocol. In addition, you can choose whether or not to allow these videos to be used for other scholarly purposes. This option is described in more detail below. We will also ask you and your child to give us permission to have your child s teacher complete a questionnaire regarding his/her behavior in school. This information will help us determine the extent of distress or interference caused by the ADHD and the specific phobia. In sum, the information collected from questionnaires, interviews, and behavioral avoidance tests will help us determine how much progress your child makes as a result of treatment. 3. DISCOMFORTS AND RISKS FROM PARTICIPATING IN THE STUDY: There may be some risks from your child s participation in this study. It is possible that your child may become upset when dealing with various aspects of the phobia. In fact, we know that

3 some discomfort is to be expected (since your child will be asked to talk about the feared object and will be asked to approach and interact with the phobic object): however, we also know that this discomfort is potentially therapeutic and will help your child overcome his/her fears. However, to minimize this discomfort and to help your child manage the discomfort should it occur, all project staff are highly trained. The therapists and graduate student clinicians working on the project have experience working with children and families, and are being supervised by Dr. Ollendick, a licensed clinical psychologist with 40 years of clinical experience. Your child does not have to answer any questions or discuss any topics that make him or her feel uneasy nor will your child ever be asked to do anything s/he is not prepared to do. Of course, your child may stop participating in the project at any time if you or your child feels too uncomfortable or simply wishes to stop. 4. EXPECTED BENEFITS: Results of this study may help us determine whether these treatments are effective for children with a specific phobia and ADHD. Such a development would allow us to share this information with other mental health professionals and to assist them in working with other families. Although no guarantee of treatment outcome can be provided, it is anticipated that this treatment will benefit your child. 5. EXTENT OF ANONYMITY AND CONFIDENTIALITY: Results of this study will be kept strictly confidential. At no time will we release your results to anyone without your written consent unless you have indicated that you will hurt yourself or someone else, or that your child has indicated that someone is hurting him/her, or that he/she has or intends to hurt himself/herself or someone else. In that situation, by law it would be necessary for us to report that information to the Department of Social Services. In all other cases, the information provided will have your child s name removed and only a subject number will identify him or her during analyses and any write-up of the research. The treatment sessions will be conducted by graduate students who are enrolled in our doctoral program in clinical psychology. These graduate students will be trained in the delivery of the treatments by Dr. Ollendick. Although the graduate students are not licensed they are highly experienced in the delivery of these experimental treatments. They will be closely supervised by Dr. Ollendick, a licensed clinical psychologist. The treatment sessions will be videotaped. The videotapes will be reviewed by Dr. Ollendick and his research assistants (undergraduate and graduate students in the Psychology Department at Virginia Tech). The videotapes are reviewed to ensure that the treatments are being delivered in the correct way. The videotapes will be erased at the end of the study, unless you and your child give us specific permission to use the videotapes for teaching and training purposes (e.g., training other therapists on how to conduct these treatments). If permission is granted to use the videotapes for teaching/training purposes, it should be understood that they would be used for such purposes at Virginia Tech as well as at local, regional, national and international conferences. The videotapes and all of the notes from the sessions will be kept in a locked file in the Child Study Center at Virginia Tech.

4 6. COMPENSATION: Treatment will be offered free of charge. 7. FREEDOM TO WITHDRAW: You are free to withdraw from participation in this study at any time without penalty. 8. USE OF RESEARCH DATA: The information from this research may be used for scientific or educational purposes. It may be presented at scientific meetings and/or published and reproduced in professional journals or books, or used for purposes that Virginia Tech s Department of Psychology considers proper in the interest of education, knowledge, or research. Only persons directly affiliated with the project, such as the Principal Investigator, Project Coordinator, graduate students in psychology affiliated with the project, or trained undergraduate research assistants will have access to confidential participant information unless you give your permission for its use in other scholarly activities (see below). 9. YOUR RESPONSIBILITIES: I voluntarily give permission for my child to participate in this study. My child has the following responsibilities: Completing study questionnaires and interviews Completing behavioral approach tasks Completing the numbers task before and after treatment via phone Attending therapy sessions Attending follow-up interviews 10. YOUR PERMISSION: I have read and understand the above description of the study. I have had an opportunity to ask questions and have had them answered. I hereby acknowledge the above and give my voluntary consent for my child s participation in this study. I further understand that if my child participates s/he may withdraw at any time without penalty. I understand that should I have any questions regarding this research and its conduct, I should contact any of the persons named below. I am also expressing my wishes about how data obtained for the project will be used. I understand that my choice of how data are used is voluntary and does not affect my child s participation in any way. I understand that I may alter my decision at any time. Please indicate your choice of how data are to be used in this project: I only want my child s data to be used in a format that conceals my child s identity. No individual information about my child or my family that could identify us may be used for scholarly purposes, such as classroom teaching, research presentations at conferences, and professional workshops. Specifically, no videotapes or video clips of me or my child can be used for these scholarly purposes.

5 I give my permission for the project to use our information including videotapes and video clips for scholarly purposes of education and training (classroom teaching, workshops, and research presentations). Since I am giving my permission for use of video materials, I realize that my identity might be able to be determined by those who watch or see these videos. I understand however that my name or the name of my child will not be used in these presentations. PRIMARY RESEARCHERS: Thomas H. Ollendick, Ph.D. PHONE: Thorhildur Halldorsdottir, M.S. PHONE: thorhh1@vt.edu CHAIR, HSC: D. W. Harrison, Ph.D. PHONE: CHAIR, IRB: David Moore; Ph.D. PHONE: moored@vt.edu CHILD S NAME: PARENT/GUARDIAN S NAME: PARENT/GUARDIAN S SIGNATURE: Date: WITNESS: Date: