RecruitingNot Applicable

Web Intervention for Parents of Youth With Genetic Syndromes (WINGS)

United States92 participantsStarted 2023-09-15

Plain-language summary

The purpose of this study is to evaluate the effectiveness of an adapted, telehealth functional behavioral therapy (FBTsIDD) specifically focused on promoting appropriate communication and behavioral strategies in individuals with syndromic intellectual and developmental disorders. Participants will be asked to complete virtual study assessments at intake and then on a monthly basis for the duration of 3-6 months. In addition, participants will attend weekly or biweekly virtual intervention visits with a study therapist.

Who can participate

Age range

2 Years – 12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age(s) 2-12 years old at time of enrollment * Existing genetic syndrome based on clinical or genetic diagnosis and confirmed by medical records * Documented diagnosis of global developmental delay (GDD) or intellectual disability (ID) * estimated ID in all ranges * Disruptive behavior challenges determined to be clinically appropriate for remote, parent-implemented coaching based on clinician determination of acuity of problem behaviors * Caregiver who is able to consent in English. * Parent/caregiver available for weekly intervention sessions * Stable psychosocial and psychiatric treatments 3 months prior to baseline visit. Exclusion Criteria: * High levels of aggression that mitigate remote or outpatient treatment as defined by clinician judgement and/or ABC Irritability scores above 20 (i.e., higher level of care needed than provided by study procedures) * Medical or psychiatric instability that may limit study participation * Meaningful change in medication or psychosocial interventions 3 months prior to baseline visit * Limitations in technology access that may hinder participation in remote trial (e.g., declining support provided by study participation)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Clinical Global Impression

Timeframe: TO (Baseline), T2 (Month 2), T4 (Month 4), T6 (Month 6)

Trial details

NCT IDNCT06139172

SponsorRush University Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12

Contact for this trial

Latha Soorya, PhD

312-942-3767 Latha_Soorya@rush.edu

View on ClinicalTrials.gov More Telomeric 22Q13 Monosomy Syndrome trials