ICCD Research Study

ICCD Research Study Form

Stars Acquisition of Regulatory Skills

  1. WHAT IS THIS FORM?
    This form will give you information about the study so that you can make an informed decision about your participation. Please ask as many questions as you need to before you decide if you want to participate.
  2. WHO IS ELIGIBLE TO PARTICIPATE?
    Any individual who is a parent of a child between the ages of three to five years of age.
  3. WHAT IS THE PURPOSE OF THIS STUDY?
    The purpose of this study is to learn more about challenges with self-regulation in early childhood. You are being asked to participate in a brief survey, so that the research team can obtain some information about the utility of a new screening tool.
  4. HOW LONG WILL THE SURVEY LAST?
    The survey is a relatively short one and should take anywhere between 10-15 minutes to complete.
  5. WHAT ARE PARTICIPANTS ASKED TO DO?
    Parents who choose to participate in this study will be asked to carefully read through and answer the STARS questionnaire. Parents are asked to consider how each question applies to their child and provide a response using a 4-point scale. The STARS consists of thirty questions.
  6. WHAT ARE THE BENEFITS OF PARTICIPATING?
    Your participation will contribute to important research that aims to support children and their families by meaningfully identifying challenges in early childhood. Additionally, you have the opportunity to enter a drawing for a $50 Amazon gift card.
  7. WHAT ARE MY RISKS OF BEING IN THIS STUDY?
    There is a possibility that answering questions about your child’s strengths and weaknesses may cause you some discomfort. There are no other foreseeable risks.
  8. HOW WILL MY PERSONAL INFORMATION BE PROTECTED?
    ICCD will follow all applicable federal and state laws that protect personal and health related information (e.g., HIPAA), including maintaining appropriate physical, electronic, and procedural safeguards. The researchers will keep all study records (including any codes to the data) in a secure location, including a locked file cabinet and password protected computer. All electronic files (e.g. database, spreadsheet, etc.) containing identifiable information will be password protected. Any computer hosting such files will also have password protection to prevent access by unauthorized users. Only the members of the research team will have access to the passwords.
    All researchers are well-trained to protect information from improper use and are bound by professional ethics to use patient information responsibly. At the conclusion of this study, the researchers may publish their findings. You and your child will not be identified in any publication or presentation. Information will be presented in summary format and all identifiers will be removed.
  9. CAN I DISCONTINUE PARTICIPATION?
    Participation in this study is voluntary. As a participant, you may withdraw at any time for any reason, without explanation, and without penalty. You may choose not to answer any questions for any reason.
  10. WHAT IF I HAVE QUESTIONS?
    If you have any concerns about your treatment as a research participant, or if you have any other questions or would like more information regarding this research project, please feel free to contact Dr. Carolyn Kuehnel at ckuehnel@iccdpartners.org.

If you do not want to talk to the investigator or study staff, if you have concerns or complaints about the research, or to ask questions about your rights as a study subject you may contact IntegReview. IntegReview’s policy indicates that all concerns/complaints are to be submitted in writing for review at a convened IRB meeting to:

Mailing Address:
Chairperson
IntegReview
3001 S. Lamar Blvd., Suite 210
Austin, Texas 78704

OR Email Address:
ckuehnel@iccdpartners.org

If you are unable to provide your concerns/complaints in writing or if this is an emergency situation regarding subject safety, contact the IntegReview office at 512-326-3001 or toll free at 1-877-562-1589.

    Research Study Form

    * Required

    1. IntegReview has approved the information in this consent form and has given approval for the investigator to do the study. This does not mean IntegReview has approved your being in the study. You must consider the information in this consent form for yourself and decide if you want to be in this study.

      STATEMENT OF VOLUNTARY CONSENT
      I have read this form and decided that I will participate in the project described above. The general purposes and particulars of the study, as well as possible hazards and inconveniences, have been explained to my satisfaction, and I agree to my participation. *

    2. We may be interested in contacting participants for follow-up data in the future (i.e., to have you complete this measure again at a later date). If you agree to the research team inviting you to participate in future studies, please write your preferred email address or phone number below:

    3. If you are interested in entering the raffle for a $50 Amazon gift card, please write your email address below:
    4. Please enter today's date. *
    5. Please enter your child's birthdate. *
    6. What is your child's gender? *
    7. What is your child's race/ethnicity? *
    8. Child's diagnosis (if any)? *
    9. Is this child your 1st, 2nd, 3rd, etc.? *
    10. Did your child have colic? *
    11. If yes, was there a medical determination for colic?
    12. Did your child participate in Early Intervention?
    13. If yes, for what services?
    14. Who is completing this form? *

    15. INSTRUCTIONS: Here are some things parents may say about their child. Read each item carefully, then mark how well it describes your child or how frequently it happens. *
      Not True at All
      (Almost Never)
      Just a Little True
      (Occasionally)
      Pretty Much True
      (Often)
      Very Much True
      (Almost Always)
      1. My child has temper tantrums that are longer than expected for his/her age.
      2. My child has a consistent sleep schedule.
      3. My child throws, breaks, or destroys things during a temper tantrum.
      4. My child dislikes the feel of certain things (e.g., clothing, water, “messy” things).
      5. My child has a temper tantrum or loses their temper “out of the blue”.
      6. My child is easy to please with meals or snacks.
      7. My child is tense, fearful, or anxious.
      8. My child wakes up very early in the morning (i.e., earlier than necessary or desired).
      9. My child is explosive or aggressive.
      10. My child tends to rock/bounce while sitting.
      11. My child seems very sensitive to light.
      12. My child is quiet and calm.
      13. My child has trouble falling asleep at night.
      14. My child regularly leaves food on his/her plate at the end of a meal.
      15. My child has eating problems, such as stuffing food, gagging, or vomiting.
      16. My child wakes up frequently during the night.
      17. My child is hypersensitive to smells.
      18. My child has more frequent temper tantrums than expected.
      19. My child has difficulty calming down when angry.
      20. My child takes longer than 30 minutes to complete a meal.
    16. INSTRUCTIONS: Here are some things parents may say about their child. Read each item carefully, then mark how well it describes your child or how frequently it happens. *
      Not True at All
      (Almost Never)
      Just a Little True
      (Occasionally)
      Pretty Much True
      (Often)
      Very Much True
      (Almost Always)
      1. My child will smell toys, clothes, or food more than usual.
      2. My child frequently bumps into or rubs against hard surfaces, even though it hurts.
      3. My child is hypersensitive to sounds.
      4. My child becomes frustrated easily.
      5. My child has a strong need to touch people and objects.
      6. My child chews or eats nonfood items.
    17. Have you started or completed potty training? *
    18. IF YES, PLEASE ALSO ANSWER THE FOLLOWING:
      Not True at All
      (Almost Never)
      Just a Little True
      (Occasionally)
      Pretty Much True
      (Often)
      Very Much True
      (Almost Always)
      1. My child has/had difficulty being daytime toilet trained (i.e., later than expected).
      1. My child has toileting accidents during the day.
      3. My child has/had difficulty being nighttime toilet trained (i.e., later than expected).
      4. My child stays dry during the night.