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| Name | Class |
|---|---|
| Emory University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Functional Behavioral Training | Experimental |
| |
| Positive Parenting Strategies-Treatment As Usual | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Functional Behavioral Training (FBT) | Behavioral | Function-based treatment (FBT) is a term for behavioral intervention approaches that use objective and systematic data collection to identify the cause of challenging behavior and teach a more prosocial replacement behavior. FBTslDD incorporates standard elements of FBT protocols with adaptations made specifically to support application to the syndromic IDD population. FBTslDD will include the following steps: (1) Syndromic IDD screening; (2) Stimulus preference assessment; (3) Indirect and descriptive assessments; (4) Screening for automatic function; (5) Functional analysis (FA); and (6) FBT intervention phase. If steps 1 - 5 determine a participant's challenging behavior serves a social function, Functional Communication Training (FCT) will be administered. If steps 1 - 5 determine a participant's challenging behavior serves an automatic function Competing Stimulus Treatment (CST) will be administered. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Global Impression | Overall functioning will be measured using the Clinical Global Impression for Severity (CGI-S) and Improvement (CGl-I). GCI-S will be recorded at Baseline with CGI-S and CGI-I collected at all determined visits. The CGI provides a rating of the child's global functioning, taking into account all available information (e.g., child's symptoms, behavior, functioning). The CGI-S and CGl-I will be completed by a blinded independent evaluator. | TO (Baseline), T2 (Month 2), T4 (Month 4), T6 (Month 6) |
| Measure | Description | Time Frame |
|---|---|---|
| Parent Target Problems (PTP) Inventory | The Parent Target Problems is a blinded rating provided by an independent evaluator and based on a caregiver interview (30-minutes at baseline; 10- to 15-minutes at follow-visits throughout the study). The independent evaluator will use the PTP interview to record the caregivers' estimate of the frequency of problematic behaviors. From this description, the independent evaluator (blind to treatment assignment) will generate a brief narrative describing the child's problem behaviors and their impact on daily functioning. The evaluator will read this back to the caregiver to provide corrections and/or add any pertinent missing information. This process will continue until the narrative represents an accurate description per caregiver report. Change on the chief concerns determined from interviews are then rated on a 9-point scale (1=normalized, 5=unchanged, 9=disastrous). The PTP has been used to measure outcomes in behavioral intervention trials. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Latha Soorya, PhD | Contact | 312-942-3767 | Latha_Soorya@rush.edu | |
| Allison Wainer, PhD | Contact | Allison_Wainer@rush.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Autism Assessment Research Treatment and Services (AARTS) Center at Rush University Medical Center | Recruiting | Chicago | Illinois | 60612 | United States |
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| Positive Parenting Strategies-Treatment as Usual | Other | Using the Planned Adaptation approach, to identify proactive adaptations seeking to improve the fit of FBTsIDD with the unique needs of the syndromic IDD population. Triangulating mixed methods data from systematic video observations, questionnaires, and qualitative interviews, then the Framework for Reporting Adaptations and Modifications-Expanded24 (FRAME) will be used to develop a rich understanding of these and any additional adaptations made to the intervention when delivered by non-specialist providers within medical hubs serving syndromic IDD populations. |
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| TO (Baseline), T2 (Month 2), T4 (Month 4), T6 (Month 6) |
| Aberrant Behavior Checklist, Second Edition (ABC-2) | The Aberrant Behavior Checklist, Second Edition (ABC-2) is a widely-used symptom checklist (completed by caregivers) that measures problematic behavior across five domain subscales: irritability, social withdrawal, stereotypic behavior, hyperactivity/noncompliance, inappropriate speech. Changes in raw scores across each subscale will be tracked against caregiver reports described in the PTP. | TO (Baseline), T2 (Month 2), T4 (Month 4), T6 (Month 6) |
| Adverse Event Monitoring | Adverse events will be measured at each time point, and the log used in this study will be based on adverse event logs that have already been developed for other ongoing NIH trials in our center. The adverse event log will include data on any adverse events, the onset date, intensity of event(s), relationship to study (i.e., unrelated through definitely related), end date, outcome, regulatory action taken (if necessary), and whether treatment was required. | TO (Baseline), T1 (Month 1), T2 (Month 2), T3 (Month 3), T4 (Month 4), T5 (Month 5), T6 (Month 6) |
| ID | Term |
|---|---|
| C536801 | Telomeric 22q13 Monosomy Syndrome |
| D014402 | Tuberous Sclerosis |
| D006223 | Hamartoma Syndrome, Multiple |
| D005600 | Fragile X Syndrome |
| D017204 | Angelman Syndrome |
| D015518 | Rett Syndrome |
| C538038 | Chromosome 15q, partial deletion |
| C535598 | Creatine deficiency, X-linked |
| ID | Term |
|---|---|
| D006222 | Hamartoma |
| D009369 | Neoplasms |
| D009378 | Neoplasms, Multiple Primary |
| D009386 | Neoplastic Syndromes, Hereditary |
| D065703 | Malformations of Cortical Development, Group I |
| D054220 | Malformations of Cortical Development |
| D009421 | Nervous System Malformations |
| D009422 | Nervous System Diseases |
| D020752 | Neurocutaneous Syndromes |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D030342 | Genetic Diseases, Inborn |
| D038901 | X-Linked Intellectual Disability |
| D008607 | Intellectual Disability |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D025064 | Sex Chromosome Disorders |
| D025063 | Chromosome Disorders |
| D040181 | Genetic Diseases, X-Linked |
| D009069 | Movement Disorders |
| D002493 | Central Nervous System Diseases |
| D000015 | Abnormalities, Multiple |
| D000096803 | Imprinting Disorders |
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