Clinical trial NCT02740309: Integrated Behavioral Health Innovations in Childhood Chronic Illness Care Delivery Systems
Official title: Integrated Behavioral Health Innovations in Childhood Chronic Illness Care Delivery Systems
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Inflammatory Bowel Disease
Keywords: inflammatory bowel disease
childhood chronic disease
adolescent depression
adolescent anxiety
integrated brief behavioral therapy
adolescent psychosocial risks
adolescent chronic disease
childhood depression
childhood anxiety
childhood psychosocial risks
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2016-04-15
Enrollment: 0
Sex: ALL
Minimum age (years): 12
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in Anxiety and/or Depression Symptoms
timeFrame: 1 year ( baseline, 8-12 weeks, 6 months, and 12 months post baseline)
measure: Treatment Engagement at Baseline
timeFrame: 1 year
measure: Screen for Childhood Anxiety Related Emotional Disorders (SCARED)
timeFrame: 1 year
measure: Children's Global Assessment Scale (CGAS)
timeFrame: 1 year
measure: Columbia Suicide Severity Rating Scale (C-SSRS)
timeFrame: 1 year
Secondary outcomes:
measure: IBD disease activity - Pediatric Ulcerative Colitis Activity Index (PUCAI)
timeFrame: 1 year ( Data will be collected at 4 time points: baseline, 8-12 weeks, 6 months, and 12 months post baseline)
measure: IBD-related quality of life-SIBDQ
timeFrame: 1 year ( Data will be collected at 4 time points: baseline, 8-12 weeks, 6 months, and 12 months post baseline)
measure: Medical Adherence Measure
timeFrame: 1 year ( Data will be collected at 4 time points: baseline, 8-12 weeks, 6 months, and 12 months post baseline)
measure: Health Care Utilization
timeFrame: 1 year ( Data will be collected at 4 time points: baseline, 8-12 weeks, 6 months, and 12 months post baseline)
measure: Pediatric Crohn's Disease Activity Index (PCDAI)
timeFrame: 1 year ( Data will be collected at 4 time points: baseline, 8-12 weeks, 6 months, and 12 months post baseline)
measure: Health Care Cost
timeFrame: 1 year ( Data will be collected at 4 time points: baseline, 8-12 weeks, 6 months, and 12 months post baseline)
Other outcomes:
Locations:
city: New York
country: United States
facility: Sala Institute for Child and Family Centered Care
state: New York
Study officials:
affiliation: NYU Langone
name: K. Ron-Li Liaw, MD
role: PRINCIPAL_INVESTIGATOR
References: