Integrated Behavioral Health Innovations in Childhood Chronic Illness Care Delivery Systems

NCT ID: NCT02740309

Last Updated: 2018-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2018-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Inflammatory Bowel Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers

Study Groups

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Integrated Brief Behavior Therapy (IBBT) Intervention

4-sessions of IBBT for youth anxiety and depression.

Group Type EXPERIMENTAL

Integrated Brief Behavior Therapy (IBBT) Intervention

Intervention Type BEHAVIORAL

The 4 sessions will empower and support families and youth to continue treatment autonomously with home practice

Treatment as usual

Treatment as usual

Group Type ACTIVE_COMPARATOR

Treatment as usual

Intervention Type BEHAVIORAL

Facilitated community referral for mental health treatment

Interventions

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Integrated Brief Behavior Therapy (IBBT) Intervention

The 4 sessions will empower and support families and youth to continue treatment autonomously with home practice

Intervention Type BEHAVIORAL

Treatment as usual

Facilitated community referral for mental health treatment

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

12 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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K. Ron-Li Liaw, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone

Locations

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Sala Institute for Child and Family Centered Care

New York, New York, United States

Site Status

Countries

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United States

Study Documents

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Document Type: Sala Institute for Child & Family Centered Care

View Document

Other Identifiers

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15-01065

Identifier Type: -

Identifier Source: org_study_id

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