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There are many different types of clinical studies, so the impact on your child's and family's life will depend on the study you're enrolled in. Some studies require minimal time and effort, such as filling out a one-time survey or having a single blood draw. Others involve regular visits to a clinic or hospital over weeks or even years.
Your consent form details what the study requires and how it might affect your family. If participating in the study becomes too burdensome for you or your child, you have the option of withdrawing.
Participation in a clinical study may require extensive time, travel, missed school days or vacations, and periods away from family and friends. It may also involve uncomfortable procedures, such as injections, and unpleasant side effects. On the other hand, being in a study may help researchers gain new scientific insights that may benefit your child or other children in the future.
Some tips for supporting your child during a clinical study:
- Include your child when possible: Depending on age and maturity level, your child may be able to understand basic facts about the clinical study. The study team should be able to explain the study and procedures in a way that is age appropriate. Allow your child to express her thoughts and feelings and ask questions.
- Listen: Check in with your child regularly by asking him how he feels and if he has concerns. Listen to what he has to say and be supportive. If your child doesn't feel well or is worried about something, let your study team know about any concerns you have so they can help. If your child can't express himself, pay close attention to any changes in his behavior.
- Set realistic expectations: Although researchers always hope the outcome of a study is successful, it may not be. This can frustrate your child, and she might feel like she's failed. Reassure her that her participation in the study is helping advance scientific knowledge and may benefit other children in the long run.
- Try to maintain a sense of normalcy: Being in a study that involves frequent doctor or hospital visits and uncomfortable procedures can make your child feel lonely and "different" from other children. It can interfere with his ability to play and do regular activities with family and friends. Look for ways to help your child maintain friendships, and plan family activities your child can still participate in.
- Get support: Connecting with other families and children participating in clinical studies can reduce feelings of isolation. Ask your study team if they can put you in touch with a support group.