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

Rush

Status: Enrolling

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

Treatments: Behavioral: Functional Behavioral Training (FBT); Other: Positive Parenting Strategies-Treatment as Usual

Study type: Interventional

Funder types: Other

Identifiers

NCT06139172

21012004

Details and patient eligibility

About

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.

Enrollment: 92 estimated patients

Sex: All

Ages: 2 to 12 years old

Volunteers: No Healthy Volunteers

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 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.

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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92 participants in 2 patient groups

Functional Behavioral Training

Experimental group

Treatment:

Behavioral: Functional Behavioral Training (FBT)

Positive Parenting Strategies-Treatment As Usual

Active Comparator group

Treatment:

Other: Positive Parenting Strategies-Treatment as Usual