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Integrated Behavioral Health Innovations in Childhood Chronic Illness Care Delivery Systems

New York, NY
N/A
Waitlist Available
Led By K. Ron-Li Liaw, MD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* All adolescents and young adults with IBD ages 12-21 years will be screened for anxiety and depression symptoms and includes youth that meet full criteria for major depressive disorder and any anxiety disorder, dysthymic disorder, and any adjustment disorder. The investigators will also include patients with subclinical symptoms that have significant psychosocial stressors in addition to their medical illness.
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group

Summary

Study design: At baseline, all adolescents and young adults with IBD ages 12-21 years will be screened for anxiety and depression symptoms using the PHQ-9 and the Screen for Child Anxiety Related Disorders (SCARED) during a routine medical visit in the pediatric gastroenterology clinic. Individuals who screen positive for depression or anxiety will be assessed to confirm diagnoses using the anxiety and M.I.N.I. 6.0. Participants will also complete a psychosocial risk assessment as well as medical and socio-demographic inventories. The investigators will include youth that meet full criteria for major depressive disorder and any anxiety disorder, dysthymic disorder, and any adjustment disorder. The investigators will also include patients with subclinical symptoms that have significant psychosocial stressors in addition to their medical illness. Patients will be excluded if they have active suicidal ideation with plan requiring ER referral, bipolar disorder, psychosis, substance dependence, eating disorders, or significant intellectual disability/developmental delay. Participants meeting inclusion criteria will be randomly assigned to four sessions of IBBT administered on-site by a Fink social worker or treatment as usual (TAU), which is a facilitated community referral for mental health treatment.

Eligible Conditions
  • Inflammatory Bowel Disease

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Anxiety and/or Depression Symptoms
Children's Global Assessment Scale (CGAS)
Columbia Suicide Severity Rating Scale (C-SSRS)
+2 more
Secondary study objectives
Health Care Cost
Health Care Utilization
IBD disease activity - Pediatric Ulcerative Colitis Activity Index (PUCAI)
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Integrated Brief Behavior Therapy (IBBT) InterventionExperimental Treatment1 Intervention
4-sessions of IBBT for youth anxiety and depression.
Group II: Treatment as usualActive Control1 Intervention
Treatment as usual

Find a Location

Closest Location:Sala Institute for Child and Family Centered Care· New York, NY

Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,430 Previous Clinical Trials
836,873 Total Patients Enrolled
K. Ron-Li Liaw, MDPrincipal InvestigatorNYU Langone
~0 spots leftby Mar 2026