RECRUITING

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

Conditions

Telomeric 22Q13 Monosomy Syndrome Tuberous Sclerosis Hamartoma Syndrome, Multiple Fragile X Syndrome Angelman Syndrome Rett Syndrome Chromosome 15Q, Partial Deletion Creatine Deficiency, X-linked

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Promoting Prosocial Behavior in Syndromic Intellectual and Developmental Disabilities

Quick Facts

Study Start:2023-09-15

Study Completion:2026-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06139172

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:2 Years to 12 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion 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 level in moderate, severe, or profound range * 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.	* 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)

Inclusion Criteria

Exclusion 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 level in moderate, severe, or profound range
* 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.

* 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)

Contacts and Locations

Study Contact

Latha Soorya, PhD

CONTACT

312-942-3767

Latha_Soorya@rush.edu

Allison Wainer, PhD

CONTACT

Allison_Wainer@rush.edu

Study Locations (Sites)

Autism Assessment Research Treatment and Services (AARTS) Center at Rush University Medical Center

Chicago, Illinois, 60612

United States

Collaborators and Investigators

Sponsor: Rush University Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-15

Study Completion Date2026-12

Study Record Updates

Study Start Date2023-09-15

Study Completion Date2026-12

Terms related to this study

Additional Relevant MeSH Terms

Telomeric 22Q13 Monosomy Syndrome
Tuberous Sclerosis
Hamartoma Syndrome, Multiple
Fragile X Syndrome
Angelman Syndrome
Rett Syndrome
Chromosome 15Q, Partial Deletion
Creatine Deficiency, X-linked