RESEARCH ON ADHD AND CONDUCT DISORDER
This page gives you important information about the research study of a treatment for Attention Deficit Hyperactivity Disorder with Conduct Disorder, which is being conducted at The University of Texas Health Science Center at San Antonio.
Why is this study being conducted?
- The purpose of this study is to test the effects of an FDA approved medication called methylphenidate on behavior in teenagers with Conduct Disorder (CD) and Attention Deficit Hyperactivity Disorder (ADHD). This study will allow us to compare the effects of different amounts of the medication on specific measures of mood and attention problems. The researchers hope to learn about the effects of methylphenidate for improving symptoms of CD and ADHD.
How can you contact study staff?
- Email: LopezA14@uthscsa.edu
- Phone: 210-567-2722
What are the study procedures?
- This study involves assessment of different moods and behaviors, health history, and measures of decision making.
- Mood and behavioral problems are measured by completing questionnaires and participating in conversations with our clinical staff.
Both the teen and a parent/guardian are asked these questions about the teen.
- A physical exam, electrocardiogram, medical history, and alcohol, drug, and pregnancy test will be conducted by the study nurse or doctor.
- During the course of the study the teen is provided with the medication and will be asked to take it every day for a total of 4 weeks.
The dosage will range between 0mg to 40mg of a long-acting form of methylphenidate.
This is not an experimental medication, it is approved by the Food and Drug Administration for the treatment of symptoms of Attention Deficit Hyperactivity with Conduct Disorder.
- Decision making (e.g. reaction time, attention, memory) is measured by computer tests which will be administered to the teen.
The tests take about 15 minutes each and are powerful tools of an individual's decision making capacity and style.
- Measures of facial expression during a listening task. Similar to a hearing test, the child will be asked to listen carefully to a series of different tones. During this task sensors will be placed around the eye area in order to measure muscle movement in reaction to the tones.
How long will study participation take?
- This is a 6 week study with each visit occurring once a week for a total of 6 visits.
- The first appointment will last about 4 hours and each remaining visit will last about 5 hours.
Who is eligible to take part in the study?
- Teenagers (ages 13-17) who are exhibiting behavioral problems at home and school which are related to Conduct Disorder and ADHD.
A parent or legal guardian is also asked to take part to provide their perspective on the teens’ medical history and adjustment.
What are factors that can disqualify you from this study?
- If the teen is not experiencing behavior problems at home and/or school.
- If the teen is currently taking prescription medication for mood or behavior problems.
- If the teen has been diagnosed or treated for a significant medical or psychiatric problem that might impair their performance
on some of our measures of decision making (e.g. seizures or head trauma)
- If the parent/legal guardian cannot give permission for the teen to participate in the research study
How is study eligibility determined?
- Families (parent/legal guardian and teen) will come to The University of Texas Health Science Center at San Antonio (UTHSCSA)
for an initial visit.
- The eligibility assessment includes questionnaires and conversations with our clinical staff with the family about the teen's health
and treatment history.
The informed consent process.
- Before any procedures are performed, the staff will explain the study procedures, benefits, risks, and confidentiality to the family.
To assist with informing the family of what to expect we will review a "consent form" which outlines all the important aspect of the study.
If both the family and the teen gives consent to take part, we will conduct the eligibility assessment.
- The consent to take part in the study is an ongoing process. We will continue to evaluate to make sure this study is prudent
for the family throughout the study.
Your decision to take part:
- Taking part in this study is always voluntary. If at anytime you wish to discontinue your participation that is your choice.
Discontinuing your participation in the study will not impact any other services you receive from
The University of Texas Health Science Center at San Antonio.
What are the benefits of taking part in the study?
- The benefits to taking part in the study are that the teen will receive a free medication which may reduce their symptoms of
Attention Deficit Hyperactivity Disorder.
What compensation is given for taking part in the study?
- If the teen qualifies and completes all six weeks of the study he/she will receive a total of $405
and the parent/guardian will receive a total of $300. A portion of which is paid at the end of each visit.
- Study medication is provided at no cost.
What are the risks of taking part in the study?
- Side effects of the methylphenidate can range from mild to serious and will usually go away after you stop taking the medication.
Some of the most frequent and less serious side effects are loss of appetite, trouble getting to sleep at night, and headaches.
In rare instances this medication can cause tics, psychotic/manic symptoms, or even death.
A thorough screening is conducted in this study by a physician to help you determine if these risks can be minimized
and if you are a safe candidate for this medication.
- A risk in taking part in this research study is providing information that you and your parent/guardian consider confidential or private.
If you decide to take part in this research study, you will be required to give us information about your health history,
your life experiences that may affect your health, and your experience with drugs and alcohol.
We have adopted a range of procedures to protect your privacy and confidentiality (including the way your data is recorded and secured and your information is protected by a Certificate of Confidentially issued by U.S.A. Department of Health and Human Services).
There are some situations when we would have to release your information to others.
These include if you are in immediate need of medical attention, if you indicate that you are going to harm yourself or others, if you have experienced abuse or neglect.
How is my privacy protected?
- This information that we learn about your family is treated as private and confidential.
We will not share the information given unless someone needs immediate medical attention,
someone indicates that they are going to harm themselves or others, if someone has experienced abuse or neglect.
- Your information will be filed by a coded number rather than by your name or other public health identifiers.
- Your information is stored in locked or encrypted secure format.
- We have taken extra steps in order to protect your privacy.
We have obtained a Certificate of Confidentiality from the National Institute on Mental Health.
This Certificate protects the research team from being forced to tell people that are not connected with this study
about your participation, even under a subpoena.
- If the results of this study are reported in medical journals or at meetings, the families that participate in our research study will not be identified.
- We do not use this page to collect or store any information.
- All information is kept at the University of Texas Health Science Center at San Antonio.
Where is this study being conducted?
- We are located in the University Plaza Building of the University of Texas Health Science Center at San Antonio.
- Our physical Address is 7526 Louis Pasteur Drive, San Antonio, TX 78229
- Map & Directions
Who funds this research?
- National Institutes of Mental Health funds this research as part of its mission to "transform the understanding
and treatment of mental illnesses through basic and clinical research, paving the way for prevention, recovery, and cure".
Conflict of Interest.
- None of the research team has any financial relationships that would influence the way that the study is conducted.
How can you contact study staff?
- Email: LopezA14@uthscsa.edu
- Phone: 210-567-2722
What is Attention Deficit Hyperactivity Disorder?
Attention Deficit Hyperactivity Disorder or ADHD is a pattern of inattention and/or hyperactivity/impulsivity that impairs a persons life at with family, friends, school, and/or work.
Symptoms of ADHD include:
- Careless mistakes on school or work activities
- Difficulty sustaining attention in work or play
- Appears not to listen when spoken to
- Fails to follow through on instructions
- Avoid tasks requiring sustained attention
- Often loses personal items
- Easily distracted by outside sights or sounds
- Often forgetful
- Often fidgets
- has trouble sitting still
- runs or climbs in situations where it is not appropriate to do so
- Difficulty playing quietly
- Often "on the go"
- Talks excessively
- Blurts out answers before questions have been completed
- Difficulty waiting turn
- Interrupts other
A person with ADHD may not have all of these symptoms, but they will have several and experience them more severely than is expected for individuals at their developmental level.
What is Conduct Disorder?
Conduct Disorder is a pattern of behavior that involves violation of the basic rights of others or societal norms.
Like ADHD, a individual does not have to have all these symptoms to have Conduct Disorder, but they do have enough symptoms that it causing the individual impairment with family, friends, school, and/or work.
Many of the Conduct Disorder symptoms are things that tend to get the child in trouble with the law.
Symptoms of Conduct Disorder include:
- Bullying others
- Initiating physical fights
- Use of a weapon in fight
- Physically cruel to people or animals
- Forced sexual activity
Destruction of Property Symptoms:
- Fire setting
- Breaking others property on purpose
- Breaking into someone else's car, building, or house
- Excessive lying, or "conning" others
Serious Rules Violation Symptoms:
- Stays out past parents curfew (starting before age 13)
- Run away from home
- Skipping school (starting before age 13)
How common is ADHD and Conduct Disorder?
- About 1 in 12 children have ADHD, although less than half of those ever receive treatment for this condition.
- About 1 in 31 children have Conduct Disorder. This is one of the most frequent conditions diagnosed at mental health treatment facilities.
- About half of children with Conduct Disorder also have ADHD.
What are the treatments for ADHD and Conduct Disorder?
- Medication: stimulant medications like methylphenidate are an FDA approved treatment for ADHD with Conduct Disorder.
- Parent Training: teaching parents on how they can manage their child's environment to reduce symptoms.
- Education: educating families about how to anticipate developmental challenges that are difficult for ADHD children,
and about ways to improve the child’s academic and behavioral functioning.
- Individual Psychotherapy: the clinician helps the child understand his/her emotions and actions, and how to deal with both
- Family Therapy: foster mutual support, positive reinforcement, direct communication, and more effective problem solving and conflict resolution
- Social Skills Training: teaching the child to identify problems, recognize causation, appreciate consequences
and consider alternate ways of handling difficult situations.
What are things families can do at home to increase the success of children with ADHD with Conduct Disorder?
- Use short explanation (10 words or less).
- Say exactly what you want.
- Speak calmly and clearly.
- Make eye contact and be aware of your body language.
- Talk about what is happening right now.
- Focus on solutions, not problems.
- Ask questions and get feedback.
- See the child as a whole person with strengths and weaknesses.
- Keep a routine and communicate that routine to the child so he/she knows what to expect.
- Keep the house organized, keep everything in its place.
- Be consistent in how you enforce rules of the household.
- Avoid punishment without the child understanding why he/she is receiving it.
- Look for opportunities to provide praise or small rewards for good behavior.