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

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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

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

Trial contacts and locations

1

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Central trial contact

Allison Wainer, PhD; Latha Soorya, PhD

Data sourced from clinicaltrials.gov

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