LET'S GET STARTED!
STEP 1: Complete the CONSENT FORM below.
STEP 2: Find a BALL AND BOOK which you will need for playing with your child.
2. CONSENT FORM: You are being asked to be in a research study. A research study is designed to answer a scientific question. If you agree to be in the study, you will be one of many other individuals who are being studied at Emory. For this study, you will be one of about 100 others.
Why is this study being done?
This study is being done to answer the question: Is it feasible for parents to perform interactive social behavioral assessments on their children. You are being asked to be in this research study because, through your participation, you will help us gather information that may lead to a better understanding of the feasibility and workload of social behavioral assessments when performed by parents on their children.
Do you have to be in the study?
It is your decision to be part of this research study. You do not have to be in it. Your choice will not affect your access to care at Emory University or health care affiliates. Before you make your decision, you should take time to learn about the study.
What do I have to do if I choose to participate in this study?
If you are eligible and want to be part of the study, you will participate for approximately 30 minutes by completing an interactive social behavior assessment on your child and filling out online questionnaires pertaining to your child's behaviors and developmental history and milestones. We are asking each parent participant to gather a ball and a book and then interact with his/her child in a particular way. We will ask them to observe the child's reactions (e.g., eye contact, smiling, and turn-taking) and answer a series of questions about the child's reactions. We will also ask about symptoms of anxiety and depression you experienced in the previous week.
To participate in this study, we are asking that you use a child's board book between 2 and 4 inches and a 3- to 4- inch ball. Ball can be larger than 4 inches across if necessary, but not be less than 3 inches across.
We are assuming that you can use materials that you already own or that these materials can be borrowed for the purpose of the assessment. It is assumed that you will have access to both a ball and a book, thus there will be no cost to you
MATERIALS: To participate in this study you will need a small ball and a board book.
How is this study going to help you?
If you are in the study, you will be helping the researchers answer the study question. Additionally, by participating in this study you will learn how psychologists observe social behavior moment by moment in young children.
What are the risks or discomforts I should know about before making a decision?
The study will take time. All studies have some risks. Some risks are relatively small, like being bored or losing time. Some are more serious - for this study, loss of privacy and breach of confidentiality could be risks. A full list of expected risks, their frequency and severity are in
the "What are the possible risks and discomforts?" section of this document below.
Alternatives to Joining This Study
Since this is not a treatment study, the alternative is not to participate.
Costs
Assuming you will have access to a child's board book between 2 and 4 inches and a 3- to 4- inch ball (Ball can be larger than 4 inches across if necessary, but not be less than 3 inches across), you WILL NOT have to pay for any of the study procedures (i.e., completing the online questionnaire).
There is more information in the cost section below.
What Should I Do Next?
Read this form, or have it read to you. Take time to consider this and talk about it with your family and friends. Because this is an online study, if you have questions about the study, even after reading the full consent form, you may decide not to participate. It is entirely your choice.
Title: Interactive Social Behavior Assessments Performed by Parents
Principal Investigator: Opal Ousley, PhD
Funding Source: Emory Autism Center
Introduction
You are being asked to be in a research study. This form is designed to tell you everything you need to think about before you decide to consent (agree) to be in the study or not to be in the study. It is entirely your choice. If you decide to take part, you can change your mind later on and withdraw from the research study. You can skip any questions that you do not wish to answer.
Before making your decision:
- Please carefully read this form or have it read to you
- Take time to consider this and talk about it with your family and friends.
- Because this is an online study, if you have questions about the study, even after reading the full consent form, you may decide not to participate.
You can make a copy of this consent form, to keep, using your computer's screen shot function. Feel free to take your time thinking about whether you would like to participate. By signing this form you will not give up any legal rights.
Study Overview
The purpose of this study is to determine the feasibility and workload of parents performing interactive social behavioral assessments on their children.
Procedures
- If you chose to participate, you will answer questions from online questionnaires.
- You will answer online questionnaires via a program called REDCap, a HIPAA approved web-based application designed to support research and data gathering.
- Each parent participant will gather a ball and a book and then interact with his/her child in a particular way. We will ask them to observe the child's reactions (e.g., eye contact, smiling, and turn-taking) and answer a series of questions about the child's reactions.
- Questionnaires will assess general information, concerns about the child, social development scale, developmental history and milestones, and anxiety and depression experienced in the previous week.
Risks and Discomforts
Risks of this study may include boredom or fatigue from participation, loss of privacy and/or breach of confidentiality.
- To minimize fatigue, you will have the option to work as quickly or slowly as you would like, as long as you
complete the study in one sitting. REDCap can "time out" if there is not continued responding.
- To minimize the risk of loss of privacy and breach of confidentiality, the REDCap program was chosen, which is a secure, HIPPA-compliant database.
Benefits
This study is not designed to benefit you directly. This study is designed to determine the feasibility and workload of parents performing social behavioral assessments on their children using provided assessment instructions. In the process you will also get to learn about how psychologists observe social behavior in young children.
Compensation
You will not be offered payment for being in this study.
Confidentiality
Certain offices and people other than the researchers may look at study records. Government agencies and Emory employees overseeing proper study conduct may look at your study records. These offices include the Office for Human Research Protections, the funder(s), the Emory Institutional Review Board, the Emory Office of Compliance. Emory will keep any research records we create private to the extent we are required to do so by law. A study number rather than your name will be used on study records wherever possible. Your name and other facts that might point to you will not appear when we present this study or publish its results.
Study records can be opened by court order. They may also be produced in response to a subpoena or a request for production of documents.
Resources
Participating in this study will not generate any clinical information. If participation in this study raises any concerns you might have for your child, it is encouraged that you discuss these with your pediatrician. To find a pediatrician near you please access the link below. If you scroll down to the bottom of the provided website you will find a section designated for helping you locate a nearby pediatrician.
https://www.healthychildren.org/English/Pages/default.aspx
Storing and Sharing your Information
Your data from this study will not be shared with anyone outside this study, even if we take out all the information that can identify you.
We will not give you any individual results from the study of the data you give us. If we find something of urgent medical importance to you, we will inform you if you have provided your contact information, although we expect that this will be a very rare occurrence.
Withdrawal from the Study
You have the right to leave a study at any time without penalty.
The researchers also have the right to stop your participation in this study without your consent for any reason, especially if they believe it is in your best interest or if you were to object to any future changes that may be made in the study plan.
Contact Information
Contact our research coordinator, Jack Olson at jolson6@tulane.edu:
- if you have any questions about this study or your part in it
- if you have questions, concerns or complaints about the research
If Jack Olson cannot be reached, please contact Dr. Opal Ousley at oousley@emory.edu.
Contact the Emory Institutional Review Board at 404-712-0720 or 877-503-9797 or irb@emory.edu:
- if you have questions about your rights as a research participant.
- if you have questions, concerns or complaints about the research.
- You may also let the IRB know about your experience as a research participant through our Research Participant Survey at http://www.surveymonkey.com/s/6ZDMW75.
1. Discoveries made in this study may lead to future research. If you wish to be contacted for other future studies conducted by our research team, please initial here: (this choice is optional):
2. Please provide your contact email if you wish to be contacted for future studies: (this choice is optional):
Here is the official and stamped Consent Form
3. REQUIRED FOR STUDY PARTICIPATION:
Please print your name and today's date below if you agree to be in this research study. By signing this consent and authorization form, you will not give up any of your legal rights. Because this is an online study, we ask that you screenshot your consent form. Consent will be stored in electronic format in REDCap and you may request additional copies of the consent by emailing jkolson@emory.edu or oousley@emory.edu.
****PLEASE PRINT YOUR NAME (ONLINE SIGNATURE) AND TODAY'S DATE IN THE FORMAT (MM/DD/YYYY)***
You must be 18 or older and able to consent
* must provide value
AT THIS POINT YOU HAVE COMPLETED THE CONSENT FORM
IF YOU HAVE PROVIDED CONSENT TO COMPLETE THE STUDY YOU WILL NOW BE MOVING FORWARD TO THE STUDY. IF YOU HAVE NOT PROVIDED CONSENT TO PARTICIPATE, PLEASE STOP HERE.
SURVEY PROGRESS (16.6% Complete)
PART 1: GENERAL INFORMATION QUESTIONS
Who provided consent for the study (on the page above)?
PLEASE NOTE:
Only a parent or legal guardian can provide consent.
* must provide value
Mother
Father
Legal guardian
Who will be the primary person completing the survey?
* must provide value
Mother
Father
Legal guardian
Teacher/daycare provider
Nurse
Medical doctor
Other
Will others assist you with this survey?
(Check all that apply).
* must provide value
Enter the child's date of birth mm-dd-yyyy
* must provide value
Today M-D-Y
Enter today's date mm-dd-yyyy
* must provide value
Today M-D-Y
Select the child's gender
* must provide value
Male
Female
CONGRATULATIONS
YOU HAVE COMPLETED PART 1 OF THE SURVEY
SURVEY PROGRESS (33.3% Complete)
Do you have any of the following concerns about the child?
1) Making eye contact with adults
* must provide value
No concern
Some concern
Definite concern
2) Smiling in response to adults
* must provide value
No concern
Some concern
Definite concern
3) Willingness to play with a ball
* must provide value
No concern
Some concern
Definite concern
4) Willingness to look at books
* must provide value
No concern
Some concern
Definite concern
5) Willingness to interact with adults
* must provide value
No concern
Some concern
Definite concern
WELL DONE!
YOU HAVE COMPLETED PART 2 OF THE SURVEY!
SURVEY PROGRESS (50% Complete)
MATERIALS NEEDED--For this part of the survey, you will need:
1) Small ball
2) Small book with pictures (e.g., Brown Bear, What Do You See?)
ACTIVITY 1. SMILING AND SAYING HELLO
INSTRUCTIONS FOR Q1 & Q2:
When you are ready to start, smile and say in a playful tone, "Hi [insert child's name]."
PAUSE for 2 seconds, and say, "Are you ready to play with some new toys?"
Lean in and keep smiling for 2 seconds.
Did the child look you in the eyes?
* must provide value
Yes
No
Did the child smile?
* must provide value
Yes
No
Q3.
For SMILING & SAYING HELLO, was the child easy to engage, taking little to no effort from you?
* must provide value
Easy to engage
Somewhat easy to engage
Hard to engage
INSTRUCTIONS FOR Q4:
Hold the ball to the right about 12 inches from your head at your eye level.
Say, "Look at my ball."
Did the child look at the ball and then back at your eyes?
* must provide value
Yes
No
INSTRUCTIONS FOR Q5 & Q6:
Say, "Let's play ball. Ready, set, GO!"
See if the child will roll or throw the ball back to you, then repeat at least 2 times, but not more than 4.
Did the child roll or throw the ball back to you one or more times?
* must provide value
Yes
No
Did the child smile?
* must provide value
Yes
No
INSTRUCTIONS FOR Q7:
On the 3rd roll say, "Ready, set" ...PAUSE for 5 seconds... "GO!"
Did the child look at you after the PAUSE?
* must provide value
Yes
No
Q8.
For BALL PLAY, was the child easy to engage, taking little to no effort from you?
* must provide value
Easy to engage
Somewhat easy to engage
Hard to engage
INSTRUCTIONS FOR Q9 & Q10:
Hold the book up to your right, at your eye level, about 12 inches from your head.
Say,"Look at my book."
Did the child look at the book and then back at your eyes?
* must provide value
Yes
No
Did the child smile?
* must provide value
Yes
No
INSTRUCTIONS FOR Q11 & Q13:
Present the book, within 6 inches in front of the child, as you read the 1st page.
Turn the page, read the 2nd page, then say, "Let's see what's next" (Wait for child to turn page).
If the child does not turn the page, turn the page for him/her.
Say, "Where is the [say the name the picture on the page]?" only once.
Then say, "Can you turn the page?" at least once, but not more than twice.
Then continue turning the pages.
Did the child turn one or more pages?
* must provide value
Yes
No
Did the child point to or tap on a picture in the book?
* must provide value
Yes
No
Did the child smile?
* must provide value
Yes
No
INSTRUCTIONS FOR Q14:
After 3 consecutive page turns, say, "Let's see what's next"...PAUSE for 5 seconds as you hold the page with your thumb, preventing the child from turning the page...then turn the page.
Did the child look at your eyes after the PAUSE?
* must provide value
Yes
No
Q15.
For the BOOK activity, was the child easy to engage, taking little to no effort from you?
* must provide value
Easy to engage
Somewhat easy to engage
Hard to engage
ACTIVITY 4. PUTTING ON A HAT
INSTRUCTIONS FOR Q16 & Q17:
Gasp while smiling. Say,"Where's the book?"
Wait 2 seconds, then say, "It's on my head, it's a hat!"
Did the child look you in the eyes?
* must provide value
Yes
No
Did the child smile?
* must provide value
Yes
No
Q18.
For PUTTING ON A HAT, was the child easy to engage, taking little to no effort from you?
* must provide value
Easy to engage
Somewhat easy to engage
Hard to engage
INSTRUCTIONS FOR Q19 & Q20:
Hold your hands up in front of you, wiggling your fingers, and say, "I'm gonna tickle you."
Wait 2 seconds, then say, "I'm gonna get you, I'm gonna get you, I'm gonna get you" while slowly leaning in toward the child.
Tickle the child GENTLY on the belly or arms, saying, "tickle tickle tickle." (REPEAT 2 TIMES).
Did the child look you in the eyes?
* must provide value
Yes
No
Did the child smile?
* must provide value
Yes
No
INSTRUCTIONS FOR Q21:
On the 3rd press say, "I'm gonna get you..." then PAUSE for 5 seconds before tickling.
Did the child look at your eyes after the PAUSE?
* must provide value
Yes
No
Q22.
For SMILING & TICKLING, was the child easy to engage, taking little to no effort from you?
* must provide value
Easy to engage
Somewhat easy to engage
Hard to engage
INSTRUCTIONS FOR Q23-Q31.
1. Place the ball and the book on the table within the child's reach.
2. Wait 10 seconds and see what the child does.
Q23.
Does the child look at the ball and then back at your eyes?
* must provide value
Yes
No
Q24.
Does the child grab either item?
* must provide value
Yes
No
Q25.
Does the child give either item to you?
* must provide value
Yes
No
Q26.
Does the child hold up and show either item to you?
* must provide value
Yes
No
Q27.
Does the child smile?
* must provide value
Yes
No
Q28.
Does the child laugh?
* must provide value
Yes
No
Q29.
Does the child talk, using words that you recognize?
* must provide value
Yes
No
Q30.
If the child talked, what words did they say? If they did not talk, answer with N/A.
Q31.
Did the child make any other sounds or noises? (e.g., babbling, humming, clicking, grunting, etc.)
Yes
No
Q32.
If the child made any other sounds or noises, please describe what sounds and noises they made. If the child did not make any other sounds or noises, please write N/A.
CONGRATULATIONS!
YOU HAVE COMPLETED PART 3 OF THE SURVEY!
SURVEY PROGRESS (66.6% Complete)
The child's race/ethinity, please check all that apply
* must provide value
The child's ethinity was selected to be "Other", please specify:
Select parent's HIGHEST LEVEL OF EDUCATION
* must provide value
Less than high school
High school degree or equivalent
Associate degree or junior college degree
College degree
Master's degree
Ph.D
Medical doctor(M.D.) or Juris Doctor(J.D.)
What is your field of study?
* must provide value
What is your zip code
* must provide value
Has the child been diagnosed with any of the delays or diagnoses below:
* must provide value
Has the child been diagnosed with any of the genetic syndromes below:
* must provide value
Please specify any other diagnoses or serious medical concerns:
Did the child's mother experience any of the following (Check all that apply):
INSTRUCTIONS: Please read the following questions and answer: YES or NO.
1. Does the child sit ALONE on the floor?
* must provide value
Yes
No
2. Does the child stand ALONE 10 seconds?
* must provide value
Yes
No
3. Does the child walk ALONE 5 steps?
* must provide value
Yes
No
4. Do you have any concerns about the child's motor development?
* must provide value
Yes
No
If yes, please specify any concerns you have about motor development:
5. Does the child use one definite and meaningful word?
(The child might not pronounce the word correctly but uses at least one word/sound consistently to refer to the same thing.)
* must provide value
Yes
No
6. Does the child say at least 10 words?
* must provide value
Yes
No
7. Does the child use two-word combinations?
* must provide value
Yes
No
8. Do you have any concerns about the child's language development?
* must provide value
Yes
No
If yes, please specify what concerns you have about language development:
9. Does the child follow a moving person with his/her eyes?
* must provide value
Yes
No
10. Does the child smile in response to his/her parent talking to him/her?
* must provide value
Yes
No
11. Does the child POINT WITH ONE FINGER for any of the following reasons?
(check all that apply)
* must provide value
Does the child look at your eyes to make sure you are looking in the direction that he/she is POINTING?
Yes
No
Child does not point
12. Do you have any concerns about the child's social development?
* must provide value
Yes
No
If yes, please specify what concerns you have about social development:
Acknowledgement
The motor, language, social development questions are adapted from the Developmental Milestones Checklist (DMC).
Developmental Milestones Checklist (DMC) was originally developed by Amina Abubakar, Penny Holding, F. Van de Vijver, G. Bomu, and A. Van Baar at the Wellcome Trust Research Programme in Kilifi, Kenya and Tilburg University in Tilburg, the Netherlands. In the second version (DMC-II), the DMC was further developed and extended by Elizabeth Prado, Amina Abubakar, Souheila Abbeddou, Elizabeth Yakes-Jimenez, Jí©ríÇme W Somí©, Jean-Boscio Ouí©draogo, and the International Lipid-Based Nutrient Supplements (iLiNS) Project team at the Institut de Recherche en Sciences de la Santí© in Burkina Faso and University of California Davis, USA. The flipchart was developed by the Summit Institute of Development in Indonesia, with the illustrations drawn by Fadlan Ahmad. The third version (DMC-III) was developed by Elizabeth Prado, Abhay Gaidhane, Zahir Quazi, and the Stepping Stones Project team at the Datta Meghe Institute of Medical Sciences in India and University of California, Davis, USA, by adding adapted items from the Parents' Evaluation of Developmental Status (Glascoe, 2003) for children age 2 to 5 years.
References:
Abubakar, A., Holding, P., van de Vijver, F. J., Bomu, G., & Van Baar, A. (2010). Developmental monitoring using caregiver reports in a resource-limited settting: the case of Kilifi, Kenya. Acta Pediatr, 99, 291-297.
Prado, E. L., A. A. Abubakar, S. Abbeddou, E. Y. Jimenez, J. W. Some and J. B. Ouedraogo (2014). Extending the Developmental Milestones Checklist for use in a different context in Sub-Saharan Africa. Acta Pediatr, 103(4): 447-454.
Glascoe, F. P. (2003). Parents' Evaluation of Developmental Status, Pediatric Society of New York.
GREAT JOB!
YOU HAVE COMPLETED PART 4 OF THE SURVEY! PLEASE FINISH BY ANSWERING SOME ADDITIONAL QUESTIONS!
SURVEY PROGRESS (83.3% Complete)
Do you have any of the following concerns about the child?
1) Making eye contact with adults
* must provide value
No concern
Some concern
Definite concern
2) Smiling in response to adults
* must provide value
No concern
Some concern
Definite concern
3) Willingness to play with a ball
* must provide value
No concern
Some concern
Definite concern
4) Willingness to look at books
* must provide value
No concern
Some concern
Definite concern
5) Willingness to interact with adults
* must provide value
No concern
Some concern
Definite concern
6) Did completing this survey change your level of concern about the child's social development or social responsiveness?
* must provide value
More concern
Less concern
No change in concern
Please describe why your level of concern has changed:
How easy was it for you to finish this survey?
* must provide value
Easy
Somewhat easy
Hard
Do you have suggestions for our survey? Please specify:
If you have any concerns about your child's development, either today or in the future, please make sure to consult with your pediatrician. You may also choose to consult with other professionals, such as a speech-language therapist, occupational therapist, or early intervention provider.
GREAT JOB! YOU HAVE COMPLETED THE SURVEY!
THANK YOU FOR YOUR PARTICIPATION! The time you have spent will help gather data on the feasibility of parents performing social behavioral assessments on their children!
SURVEY PROGRESS (100% Complete)