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Behavioural Intervention

Virtual Therapy for Developmental Disabilities

N/A

Waitlist Available

Research Sponsored by Rush University Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Existing genetic syndrome based on clinical or genetic diagnosis and confirmed by medical records

Caregiver who is able to consent in English

Timeline

Screening 3 weeks

Treatment Varies

Follow Up to (baseline), t1 (month 1), t2 (month 2), t3 (month 3), t4 (month 4), t5 (month 5), t6 (month 6)

Awards & highlights

Study Summary

This trial tests a virtual therapy program to help people with intellectual and developmental disorders better communicate and manage their behavior. Participants will do assessments and have weekly or biweekly virtual visits with a therapist.

Who is the study for?

This trial is for children aged 2-12 with certain genetic syndromes like Fragile X or Rett Syndrome, who have moderate to profound intellectual disabilities and behavioral challenges. They need a caregiver who speaks English and can attend weekly online sessions. Kids unstable medically or psychiatrically, recently changing treatments, or lacking tech access for telehealth are excluded.Check my eligibility

What is being tested?

The study tests an adapted telehealth functional behavioral therapy (FBTsIDD) aimed at improving communication and behavior in kids with developmental disorders. It involves virtual assessments and regular online sessions with therapists over 3-6 months.See study design

What are the potential side effects?

Since the intervention involves behavioral training and parenting strategies rather than medication, there may not be physical side effects. However, participants might experience frustration or stress during the learning process of new behaviors.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a confirmed genetic syndrome.

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My caregiver can understand and consent in English.

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I am between 2 and 12 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ to (baseline), t1 (month 1), t2 (month 2), t3 (month 3), t4 (month 4), t5 (month 5), t6 (month 6)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~to (baseline), t1 (month 1), t2 (month 2), t3 (month 3), t4 (month 4), t5 (month 5), t6 (month 6)

This trial's timeline: 3 weeks for screening, Varies for treatment, and to (baseline), t1 (month 1), t2 (month 2), t3 (month 3), t4 (month 4), t5 (month 5), t6 (month 6) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Parent Target Problems (PTP) Inventory

Secondary outcome measures

Aberrant Behavior Checklist, Second Edition (ABC-2)

Adverse Event Monitoring

Clinical Global Impression

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Functional Behavioral TrainingExperimental Treatment1 Intervention

Group II: Positive Parenting Strategies-Treatment As UsualActive Control1 Intervention

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Rush University Medical CenterLead Sponsor

423 Previous Clinical Trials

164,031 Total Patients Enrolled

Emory UniversityOTHER

1,641 Previous Clinical Trials

2,561,810 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are elderly individuals aged 50 and over able to participate in this trial?

"This clinical research is accepting participants aged between 2 years old and 12."

Answered by AI

Is there an ongoing opportunity to join this research project?

"This medical trial, which commenced on September 15th 2023 and last updated November 14th, is not currently recruiting. However, information posted to clinicaltrials.gov lists 1,566 other trials that are actively seeking participants at this time."

Answered by AI

Am I a viable candidate for this experiment?

"Participation in this medical trial necessitates that individuals must have tuberous sclerosis, be aged between two and twelve years old, and there is space for a total of 92 patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Promoting Prosocial Behavior in Syndromic Intellectual and Developmental Disabilities

2023. "Promoting Prosocial Behavior in Syndromic Intellectual and Developmental Disabilities". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06139172.

All > Fragile X Syndrome > Angelman Syndrome