Behavioral Health Clinical Research

What is the purpose of this study?

Researchers at Nationwide Children’s Hospital are conducting a study about how omega-3 and omega-6 fatty acids affect cognitive abilities in children with autism spectrum disorder (ASD).

We eat omega-3 and omega-6 fatty acids as part of a regular diet. They are important for brain function. It is important that we understand how much omega-3 and omega-6 fatty acids people should eat to best support brain function. Our study is hoping to provide better information about omega-3 and omega-6 fatty acids for children with Autism Spectrum Disorder.

Who can participate in this study?

If you have a child with ASD who is between 3 and 6 years old, you may be eligible to participate.

What will happen during this study?

There are two parts to this study.

• Part 1: We will ask you to answer questions on your computer at home about your home, your child, and you child’s diet.

• You will be entered into a drawing for $25 if you complete these online questions.

At the end of Part 1, you can indicate if you are interested in Part 2.

• Part 2: You and your child will visit Nationwide Children’s Hospital for about 1 ½ hours.

  • We will do activities with your child. These include playing with toys and playing games on an iPad.

  • We will collect saliva and a small blood sample at the end of the visit.

  • You will be compensated $25 for your participation.

  • We will pay for your parking in the hospital parking garage.

Who can I contact for more information?

Dr. Kelly Sheppard
Center for Biobehavioral Health
Phone: 614-355-3696
Email: Kelly.sheppard@NationwideChildrens.org

What is the purpose of this study?

The Family Well-Being Study aims to increase healthcare provider understanding of how differences of sex development (DSD) affect the quality of life of children and their families. With this information, we hope that providers will learn how to best support patients with DSD and develop programs addressing their specific needs so that they can thrive.

Who can participate in this study?

• Parents of children ages 0-19 with differences of sex development (DSD)

• Participants must be able to read and understand English

What will happen during this study?

• You will complete an online questionnaire that will be used to understand the thoughts and feelings of parents of children affected by congenital conditions.

• This questionnaire will be completed once at your convenience and will require about 40 minutes of your time.

• Participation in this research study is voluntary and may be discontinued at any point during the project.

• Your participation or lack thereof will not impact your family's care at Nationwide Children's Hospital.

• You will be compensated for your time.

Who can I contact for more information?

To learn more or participate in the Family Well-Being Study, please contact Hillary Kapa, Clinical Research Coordinator, at 614-722-2830 or ThriveStudies@NationwideChildrens.org. 

What is the purpose of this study?

The Family Well-Being Study seeks to understand how children’s congenital conditions impact the psychosocial well-being and quality of life of their parents and families.

Who can participate in this study?

• Parents of physically and mentally health children ages 0-19 years old who will act as matched controls for patients affected by congenital conditions

• Participants must be able to read and understand English

What will happen during this study?

• You will complete an online questionnaire about how your feelings and experiences impact your well-being.

• This questionnaire will be completed once at your convenience and will require about 40 minutes of your time.

• Participation in this research study is voluntary and may be discontinued at any point during the project.

• Your participation or lack thereof will not impact your family’s care at Nationwide Children's Hospital.

• You will be compensated for your time.

Who can I contact for more information?

To learn more or participate in the Family Well-Being Study, please contact Hillary Kapa, Clinical Research Coordinator, at 614-722-2830 or ThriveStudies@NationwideChildrens.org. 

What is the purpose of this study?

The Youth and Young Adult Resiliency Study explores how differences of sex development (DSD) impact quality of life. This is a collaborative study between Nationwide Children's Hospital and Boston Children's Hospital. During this study, healthcare providers aim to learn what factors lead to the best outcomes for patients with DSD. With this information, providers hope to be proactive in supporting patients with DSD so that they can be their happiest and healthiest selves.

Who can participate in this study?

• Youth and young adults ages 12-26 with differences of sex development (DSD)

• Participants must be able to read and understand English

What will happen during this study?

• You will complete an online questionnaire about how your feelings and experiences impact your well-being.

• This questionnaire will be completed once at your convenience and will require about 40 minutes of your time.

• A select number of participants will also complete a single face-to-face interview.

• Participation in this research study is voluntary and may be discontinued at any point during the project.

• Your participation or lack thereof will not impact your care at Nationwide Children's Hospital.

• You will be compensated for your time.

Who can I contact for more information?

To learn more or participate in the Youth and Young Adult Resiliency Study, please contact Hillary Kapa, Clinical Research Coordinator, at 614-722-2830 or ThriveStudies@NationwideChildrens.org.

• Contact Urology

• Contact Endocrinology

• Learn more about the THRIVE Program, specializing in care for differences of sex development

What is the purpose of this study?

The Life After Pregnancy Study is a one-time survey study for mothers of babies.

It is a 40-minute survey about the joys and challenges of being a new mother. Participants are asked questions about the birth and feeding of one’s child, one’s physical health and emotional well-being, as well as services one may have received. The research team hopes to learn more about the experiences of new mothers to improve services offered both before and shortly after birth.

Who can participate in this study?

Women are eligible to participate in this study if they:

1. Are 18 years of age or older and
2. Have a child between 2 and 6 MONTHS of age.

How can I get more information or participate?

If you are interested in participating in our Life After Pregnancy Study, please click the link below to read about your rights as a research participant and take the survey.

If you have questions about the study, you can reach us at 614-355-3578 or LAPS@NationwideChildrens.org.

What is the purpose of this study?

SPARK stands for Simons Foundation Powering Autism Research for Knowledge. The mission of SPARK - an online research partnership involving 50,000 individuals with autism and their families - is simple: to speed up research and advance understanding of autism.

For additional information on SPARK, please visit the SPARK website for Nationwide Children's Hospital.

Who can participate in this study?

SPARK is open to individuals of all ages with a professional diagnosis of autism spectrum disorder (ASD) living in the United States. ASD includes Asperger syndrome, autism/autistic disorder and pervasive development disorder-not otherwise specific (PDD-NOS). Participants are welcome to invite biological parents and full biological siblings (with and without ASD) to participate as well.

What will happen during this study?

Participants will be asked to share medical and genetic information with researchers and to agree to be contacted about future research studies. One of SPARK's key goals is to enable research that has not been possible before by linking individuals in the scientific community with autism research participants.

Who can I contact for more information?

For more information on this study, or if you are interested in participating, please contact Sara Eldred by phone at 614-722-4115 or by email at Sara.Eldred@NationwideChildrens.org.

What is the purpose of this study?

We are doing this research study to look at the bacteria in the stomach of children.

Who can participate in this study?

Children between 4-12 years of age can participate in this study. We are looking for four groups of children in this age range:

• Children with autism, with and without stomach pain

• Siblings of children with autism, with no stomach pain

• Children without autism and with no stomach pain

• Children without autism and with stomach pain

What will happen during this study?

The study includes two visits and a completing a two-week diary of food, stool and stomach pain.

• The first study visit involves getting consent or approval, providing study information, doing a cheek swab, and receiving surveys that can be done at the visit or taken home.

• The second study visit involves getting back the completed surveys, getting a stool specimen and being reimbursed for your time.

Participating is easy, and there is no pain involved with either of the two study visits. 

Who can I contact for more information?

For more details, please contact Caitlin Hayes at 614-722-3470. This study is funded by Autism Speaks.

What is the purpose of the study?

This study is comparing different ways to assist parents in helping their young children sleep better. When young children sleep better, parents and other caregivers often sleep better. 

Who can participate in this study?

• Parents or caregivers of children between 6 months and 36 months of age who are interesting in learning about ways to help their child sleep better and want their child to sleep independently.
• Independently means that the child sleeps outside of your bed AND needs as little help as possible to fall asleep or stay asleep.
• If you are a parent or caregiver who lives in the same household as the child for at least 4 nights per week with access to a DVD player, internet, and regular access to a telephone, you may qualify for this study. 

Participation in this study is completely voluntary. If you do not want to be involved with this study, all regular and standard medical care will still be available to you through your practice and Nationwide Children’s Hospital. You can talk to your regular doctor about clinic-based counseling, which has been previously shown to assist parents in helping young children sleep better. You also have the right to leave this study at any time, even if you agree to join now.

What are the possible risks/discomforts and benefits?

It is possible that you could feel upset when answering questions about you or your child, but it may be more likely that you find the questions a little boring. You do not have to answer any question that you dislike or find upsetting. Possible benefits to you might be learning better ways of helping your child sleep.

You will also be compensated for participation after completing the 3-week survey. 

Who can I contact if I am interested or if I have any questions?

If you are interested in participating, please access this research project and sign up online at this website. If you would like more information or if you have any questions, please call Jules Arthur, Clinical Research Coordinator at Clinical Research Services at Nationwide Children’s Hospital at (614) 722-2656.

Purpose of study:

(Non-Down Syndrome: HR-ALL or VHR-ALL)

Induction

In the initial stage of treatment for ALL, called Induction, we try to remove all visible signs of leukemia and allow normal blood cells to be restored. This is called remission. The cancer fighting medicine (chemotherapy) given during Induction on this study is one of the current standard Induction treatments for HR-ALL (High Risk B-precursor Acute Lymphoblastic Leukemia). Five chemotherapy drugs are used during this part of treatment.

The purpose of this part of the study is to collect information about your leukemia that will be used to guide further therapy and to understand effects of Induction therapy on you. Information gathered on the AALL08B1 will be used to help further define your risk group and guide further therapy. (AALL08B1 is a biology study, required prior to the theraputic study AALL1131). Your doctor will know your final risk group by the end of Induction. You will be offered the chance to continue treatment on other parts of this study once your final ALL risk group is known.
The overall goal of this study is to collect information about your leukemia and about the effects of the first phase of treatment, called Induction.

Post Induction

Even though treatment success rates are very good for people with HR-ALL, some patients still have relapse of their leukemia. Therapy on this study attempts to decrease the number of people who relapse in the central nervous system. This is called CNS relapse.

The CNS is made up of the brain and spinal cord and the fluid that surrounds them. One of the ways doctors try to prevent CNS relapse is by giving some of the chemotherapy into the fluid surrounding the spine. Medicines given into the spinal fluid are given intrathecally or IT. This study looks at how well CNS relapse can be prevented in children with HR-ALL by comparing the use of 3 drugs (methotrexate, hydrocortisone, and cytosine arabinoside) given intrathecally. This is called triple intrathecal therapy or ITT. We will compare ITT to the standard use of 1 drug (methotrexate) given intrathecally (IT MTX). The use of ITT is experimental on this study. However, ITT has been given to many people will ALL and has been well tolerated. We do not know which approach is better. That is why we are doing this study.

This study also includes studies that aim to better understand the things that contribute to side effects of cancer treatment, and how to prevent them or reduce them as much as possible.
The overall goals of this study are to:

• Find out if using chemotherapy with ITT improves survival rates better than using chemotherapy with IT MTX for HR-AL
• Compare the effects, good and/or bad, of chemotherapy with ITT to chemotherapy with IT MTX for HR-ALL to find out which is better. In this study, you will get either the ITT or the IT MTX. You will not get both.

Other goals of this study are:

• To better understand the effects of cancer treatment in people with HR-ALL (Down Syndrome: DS-ALL or DS HR-ALL).

In a recently completed COG study, several patients with DS HR-ALL died from infections during treatment, mainly during Induction and Maintenance. Infections and death are known possible complications of treatment, but more of these complications occurred in patients with Down syndrome.

On this study, Induction and Maintenance therapy (described below) have been changed from the usual treatments in an effort to decrease toxicity. We do not know if these changes will decrease toxicity. Therefore, we also will closely monitor patients, with the aim of reducing the number of unintended and unwanted results of treatment (serious side effects) and deaths among children and adolescents with DS HR-ALL.

Methotrexate is a cancer-fighting drug that is very important in the treatment of leukemia. During the Interim Maintenance phase of treatment methotrexate is usually given as High dose methotrexate. In “high dose” methotrexate therapy, the same dose of methotrexate is given a total of 4 times (every 2 weeks over a 9-week period). However, because subjects with DS are particularly sensitive to drugs like methotrexate, the High dose methotrexate on this study will be modified to a somewhat lower dose called Intermediate dose methotrexate. We do not know if intermediate dose methotrexate given during Interim Maintenance will be helpful for DS HR-ALL, and it may increase the side effects of treatment.

This study also aims to understand the biology of DS HR-ALL better, by testing blood or bone marrow for changes in certain genes. Genes are materials that determine the makeup of the body. We would to learn more about these abnormal changes in genes in patients with DS HR-ALL (called high risk genetic lesions). We would also like to look at levels of white blood cells in the blood (called absolute lymphocyte count) at the end of Induction therapy. This would help us learn more about DS HR-ALL, and may help us to guide therapy for patients in the future.

The overall goals of this study are to:

• Find out if children with DS HR-ALL will have improved outcomes with a less intense therapy given during the Induction phase of therapy.
• Find out if children with DS HR-ALL will have improved outcomes with fewer courses of prednisone and vincristine given during the Maintenance phase of chemotherapy.
• Find out if boys with DS HR-ALL will have improved outcomes with approximately 2 years of Maintenance therapy, the same length of treatment given to girls, instead of 3 years of Maintenance therapy, which has been given to boys on some past studies.
• Find out if children with DS HR-ALL will have improved outcomes with increased safety and supportive care recommendations.
• Find out the effects, good and/or bad, of using intermediate dose methotrexate during Interim Maintenance phase of therapy on children with DS HR-ALL.

Their goals of this study are:

• To learn more about the biology of DS HR-ALL through specialized tests.

Who can participate:

Patients must have newly diagnosed B-precursor ALL. Patients with Down syndrome are also eligible.

Patients must not have received any prior cytotoxic chemotherapy for the current diagnosis of ALL or any cancer diagnosed previously, with the exception of steroids and intrathecal cytarabine for the current diagnosis of ALL. Patients cannot have secondary ALL that developed after treatment of a prior malignancy with cytotoxic chemotherapy.

Patients receiving prior steroid therapy may be eligible for AALL1131

Additional screening for eligibility will be required.

What will happen during the study:

(Non-Down Syndrome: HR-ALL or VHR-ALL)

Random Assignment

People taking part on this study (subjects) will receive 1 of 2 different treatment plans (also called ‘arms’). The treatment plan that you receive is decided by a process called randomization. Randomization means that the treatment is assigned based on chance. It is a lot like flipping a coin, except that it is done by computer. The randomization process will occur after Induction therapy (at the time when your risk status is determined to be HR-ALL) but prior to the start of Consolidation therapy.

If you agree to this randomization, you will have an equal chance of being assigned to 1 of the 2 different arms. Some subjects will be randomized to receive treatment on Arm A; others will be randomized to receive treatment on Arm B for all phases of post-Induction therapy. The 2 treatment arms in this study are the same standard or regular therapy for people with HR-ALL except for differences in the type of intrathecal therapy subjects receive.

Arm A: Patients receive therapy that is standard including age adjusted intrathecal methotrexate.

This is the standard arm.

Arm B: Patients receive therapy that is standard with triple intrathecal therapy (methotrexate, hydrocortisone and cytosine arabinoside) instead of intrathecal methotrexate. This is the experimental arm.

Induction

People taking part on this study (subjects) will receive a standard treatment plan during Induction. Induction therapy will be given over 4 weeks.

Post Induction

A number of factors were used to identify you as having HR-ALL. These factors included the results of research tests (FISH, MRD and hypodiploidy) done on leukemia cells before the start of, and during Induction therapy, as well as your age and the presence or absence of leukemia cells in your spinal fluid or brain.

The treatment involves cancer fighting medicine called chemotherapy and radiation therapy for patients with testicular disease. Post-Induction treatment on this study is divided into 4 stages: Consolidation, Interim Maintenance, Delayed Intensification and Maintenance.

Timing

Female patients are expected to receive treatment on this study for about 2¼ years. Because males receive longer Maintenance therapy, males are expected to receive treatment on this study for about 3¼ years.

(Down Syndrom: DS-ALL or DS HR-ALL)

The treatment plan involves cancer fighting medicine called chemotherapy as well as radiation therapy for people taking part in this study (subjects) with leukemia cells in the testes. Treatment on this study will be given in the following phases: Induction, Consolidation, Interim Maintenance, delayed Intensification and Maintenance. Subjects are people who agree to participate in this study.

Studies have shown that subjects who have Down syndrome are more likely to suffer serious side effects from treatment with chemotherapy than subjects without Down syndrome. Subjects with Down syndrome are particularly sensitive to certain chemotherapy medications, such as methotrexate. To help lessen the side effects of methotrexate, you will be given a vitamin called leucovorin, every time you are given methotrexate into your spinal fluid except during Maintenance therapy. You will also be closely monitored throughout your treatment for various side effects. Additionally, you will be receiving treatment during Induction and post-Induction with the following modifications:

Induction
During Induction, subjects will receive modified therapy that is less intense than normal. Therapy will be given in such a way that subjects that do not need an additional drug, daunorubicin, will not have to be exposed to the side effects that this drug may have. This will be determined by a bone marrow test that will be done halfway into Induction therapy.

All subjects get the same treatment in the first half of Induction, except for the type of steroid used; which will depend on your age.

If you are less than 10 years old, the steroid dexamethasone will be used. If you are equal to or above 10 years old, prednisone will be used.

After all patients have received Induction treatment for 14 days, a bone marrow test will be done to assess your response to the treatment so far (called early response status). The remaining therapy you get for Induction will depend on your early response status, described below:

• Rapid Early Responders (RER) these subjects respond quickly to treatment. The results of bone marrow tests show signs that the leukemia has been removed and these patients reach remission very soon after the start of treatment. Rapid early responders will therefore continue with Induction therapy as before, for the remainder of Induction therapy.
• Slow Early Responders (SER) these subjects respond to treatment more slowly and take longer to reach remission. Also, once they reach remission, more therapy is needed to maintain that remission. Since SERs are at greater risk of the leukemia coming back, for the remainder of Induction therapy, they will continue with treatment as before, plus they will receive an additional drug called daunorubicin. The dose of daunorubicin that is given on this study is lower than that used on previous studies.
• Because chemotherapy can make your blood counts low causing serious side effects like infections and bleeding, you will also get a drug called a myeloid growth factor (example filgrastim) that will help your counts to recover.

Post-Induction

During Interim Maintenance, subjects with Down syndrome will be given intermediate dose methotrexate instead of high dose methotrexate because it is known that children with Down syndrome are more sensitive to this drug.

During Maintenance, all subjects will receive the drugs vincristine and prednisone. These drugs are known to have short and long term side effects. Long term side effects are harmful effects seen months or years after you have finished your treatment, and children with Down syndrome have had more serious side effects during Maintenance than other children. Therefore in this study, vincristine and prednisone will be given at regular 12 week intervals (called pulses) for children with Down syndrome, instead of 4 week intervals as will be given to other children on the study, in order to try and reduce these bad effects. In most COG ALL studies, boys are treated for about a year (12 months) longer than girls. In this study, boys will be treated for the same length of time as girls to reduce the risk of serious side effects during Maintenance treatment.

Timing

People in this clinical trial are expected to receive treatment on this study for about 2 ½ years. After treatment, you will have follow-up examinations and medical tests.

Who to contact:

PI: Mark Ranalli, MD
614-722-3563
Mark.Ranalli@nationwidechildrens.org

Purpose of study:

When patients have spinal surgery, electrodes are placed in many places on the body to measure the nerve signals coming from the spinal cord. This is called motor evoked potentials (MEP) and somatosensory evoked potentials (SSEP). The anesthesia that is used to keep patients asleep during surgery can either be given through an intravenous catheter (IV) or inhaled through the breathing tube. Many hospitals only use IV anesthesia because they feel that measuring MEP and SSEP is easier using IV anesthesia. At this hospital we typically use inhaled anesthesia and are able to successfully measure MEP and SSEP. This is a study to find out if one method of anesthesia is better than the other for measuring MEP and SSEP.

Who can participate:

Patients with idiopathic scoliosis

What will happen during the study:

This study will consist of one visit and will last from the time you are taken back to the operating room until the day after your surgery. You will be taken to surgery and be put to sleep with gas that you inhale. After you are asleep you will have an IV started and a tube will be placed in your throat to help you breathe. You will receive anesthesia either through the IV or through the breathing tube, which will keep you asleep and without pain until the surgery is finished. Electrodes will be placed on your head, trunk, arms, and legs to measure MEP and SSEP. MEP and SSEP will be measured 4 times during the surgery. You will also have about 6 mls (½ tablespoon) of blood taken right after you go to sleep, at the end of your surgery, and the day after your surgery. The total amount of blood will not be more than about 20 mls or 1½ tablespoons. This blood will be taken from your IV so you will not have an extra needle stick.

Who to contact:

Julie Rice, RN, BSN, CCRC 355-3142 Julie.Rice@nationwidechildrens.org.

Purpose of study:

Some studies of older adults taking medications known as Selective Serotonin Reuptake Inhibitors (SSRIs) suggest that they may be at greater risk for broken bones. Dr. Gracious is interested in finding out if adolescents and young women who have been taking an SSRI for at least two years are at risk for broken bones because of a decrease in their bone density.

Who can participate: 

Caucasian adolescents ages 7 to 11 and young women ages 16 to 20 years of age who have been taking one of the listed antidepressant medications for at least 2 years:

Citalopram (Celexa) Escitalopram (Lexapro)
Fluvoxamine (Luvox) Fluoxetine (Prozac)
Paroxetine (Paxil) Sertraline (Zoloft)?

What will happen during the study: 

Qualified volunteers will have a comprehensive medical history of potential factors affecting bone health, a limited physical examination, a bone density test, hand x-ray, a blood draw, and a urine test at no cost to you. Participants will be compensated for their time. This study involves one visit which takes about an hour and a half to two hours. ?

Who to contact: 

Rachel Jones
Rachel.Jones2@nationwidechildrens.org
(614) 722-3221

Purpose of study:

We are doing this research study to see if a medicine called memantine is helpful in improving motor skills and memory of children with autism.

Who can participate: 

Children 6-12 years of age who have been diagnosed with an autism spectrum disorder and have problems with memory and motor skills (clumsiness, coordination, balance, precise movements).

What will happen during the study: 

This study will last for about 6 months, with 11 visits and 2 phone calls. During this time, the following tests or procedures may be done - physical exams, blood draws, parental interviews and testing related to IQ, motor skills, memory.

Who to contact: 

Melinda Helton, RN
Melinda.Helton@NationwideChildrens.org
(614) 722-2650