Question 1

What is the purpose of the study?

Accepted Answer

The purpose of this study is to evaluate the effectiveness of two telehealth treatments:

• An adapted, telehealth functional behavioral therapy (FBTsIDD).   
 
 • An evidence-based positive parenting intervention (PPT) commonly used to help parents implement proactive and positive behavioral strategies in the home.

Study participants will be randomly selected (like flipping a coin) to receive either (1) FBTsIDD treatment or (2) positive-parenting treatment.

Participants will be told which group they are in, and they will have an equal chance of being selected for either group.

Question 2

Who can join the study?

Accepted Answer

To be eligible to participate, children and families must meet the following criteria:

1. Children aged 2-12 years at the time of enrollment.
2. Children with an existing genetic syndrome, diagnosed clinically and confirmed by medical records.
3. Children with a documented diagnosis of global developmental delay (GDD) or intellectual disability (ID).
4. Estimated ID level in all ranges.
5. Children exhibiting disruptive behavior challenges, deemed clinically appropriate for remote, parent-implemented coaching (based on the clinician's determination of the acuity of problem behaviors).
6. Parent/caregiver able to provide consent in English.
7. Parent/caregiver available for weekly intervention sessions.
8. Stable psychosocial and psychiatric treatments for the 3 months preceding the first visit

Question 3

Who is not eligible to participate?

Accepted Answer

To be eligible, children and families must not:

1. Have high levels of aggression that hinder remote or outpatient treatment (as determined by clinician judgment).
2. Have medical or psychiatric instability that may limit participation in the study.
3. Have a parent/caregiver with limitations in technology access that may impede participation in telehealth interventions.
4. Have experienced meaningful changes in medication or psychosocial interventions in the 3 months prior to the baseline visit.

Question 4

What activities will participants engage in during the study?

Accepted Answer

Consent and Clinical Screening
Before any study activities begin, the study team will go over all study procedures in detail and review the Consent Form with you. Consent is completed virtually. Once the form is signed, you will participate in a 90-minute Clinical Screening call with one of our clinicians. During this call, we will review your child's medical history and confirm eligibility by verifying their genetic syndrome and diagnosis of Intellectual Disability.

Baseline Assessments
If your child meets eligibility, you will begin by completing parent interviews. These include two Baseline Visits or calls (Visit 1 and Visit 2), each lasting approximately 2 hours. You will also complete electronic parent surveys. These activities are designed to help us better understand your child's behavior, adaptive skills, and development.

Randomization and Start of Therapy
After completing the Baseline Assessments, if eligible, your child will be randomly assigned (similar to flipping a coin) to one of the two treatment groups:  
 • An adapted, telehealth functional behavioral therapy (FBTsIDD), or
 • A positive parenting intervention (PPT), commonly used to help parents implement proactive and positive behavioral strategies at home.

Our team will maintain ongoing communication regarding eligibility. If, at any point, your child is deemed ineligible, we will notify you promptly.

Telehealth Behavioral Intervention Sessions (60 minutes)
You and your child will participate in weekly virtual therapy sessions for approximately six months. The intervention will be divided into two phases:
 • Phase 1 (Weekly Sessions): Lasting around 16 weeks
 • Phase 2 (Bi-Weekly Maintenance Phase): Lasting up to 8 weeks

These sessions may include coaching strategies to help implement intervention techniques at home.

Study Assessments and Monthly Check-Ins
During your participation, you will complete monthly check-ins (15-20 minute phone calls) with an independent evaluator. These check-ins may include electronic surveys and parent interviews, including longer interviews at Month 4 and Month 6 (end of study). Monthly standardized assessments will evaluate your child's behavior and communication using various measures.

Follow-Up Interviews
After the intervention is completed, you might be invited to provide feedback about the acceptability and fit of the intervention within your family and the broader syndromic IDD community.

Question 5

What is the expected duration of the study?

Accepted Answer

The study may last up to 7 months.

Question 6

Where and when is the study happening?

Accepted Answer

This research study will be conducted entirely through a telehealth intervention. Meaning we will use technology, such as video calls, phone calls, or online platforms, to complete study activities remotely.

It's important that parents/caregiviers  have good and dependable technology. This helps make sure everything goes smoothly

Question 7

Will participants receive compensation for their involvement in the study?

Accepted Answer

Depending on the completed study visits, participants will be compensated for up to $165.00.

Question 8

I need a device for remote telehealth sessions. What support will be available to help me set it up for the virtual sessions, and can I get assistance with using my own device if I prefer that?

Accepted Answer

Yes, we understand that families may prefer using their own technology, and that's perfectly fine. When needed, we will provide a study Technology Kit, complete with a detailed guide and instructional video.

Our research staff will assisting setting up the technology, conduct a practice run, and guide families in selecting an appropriate location for study assessments. Our goal is to ensure functional technology and help families feel prepared for the virtual sessions.

OUR RESEARCH

What is WINGS (Web Intervention for Parents of Youth with Genetic Syndromes)?

Rush University Medical Center

Austism, Assessment, Research and Treatment Center

Autism, Assesment, Research and Treatment Center

1645 W. Jackson Blvd, Suite 603
Chicago, IL 60612

Phone:

312.563.2844

Email:

WINGSStudy@rush.edu