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Integrated Behavioral Health Innovations in Childhood Chronic Illness Care Delivery Systems

Primary Purpose

Inflammatory Bowel Disease

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Integrated Brief Behavior Therapy (IBBT) Intervention
Treatment as usual
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inflammatory Bowel Disease focused on measuring 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

Eligibility Criteria

12 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sala Institute for Child and Family Centered Care

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Integrated Brief Behavior Therapy (IBBT) Intervention

Treatment as usual

Arm Description

4-sessions of IBBT for youth anxiety and depression.

Treatment as usual

Outcomes

Primary Outcome Measures

Change in Anxiety and/or Depression Symptoms
Anxiety and depression symptoms are hypothesized to decrease more in the IBBT-4 group and psychosocial functioning is hypothesized to improve more in the IBBT-4 group as compared to TAU. The number of patients who no longer meet criteria for depression and/or anxiety after brief intervention is hypothesized to be greater than as compared to TAU. The Patient Health Questionnaire (PHQ-9) will be repeated self-report measures of depression and anxiety symptoms at each time point to assess symptomatology.The PHQ-9 consists of 9 questions scored 0-3, with 3 denoting the early every day ( highest value).
Treatment Engagement at Baseline
One visit is the modal number of encounters for patients seeking treatment in the community mental health care settings. The investigators hypothesize that by implementing an integrated behavioral health model that identifies mental health issues in medical settings as part of routine care and engages individuals in on-site treatment for depression and anxiety will increase the number of completed mental health encounters utilized and the number of successful referrals to community mental health providers when ongoing treatment is needed. Multiple measurements will be aggregated to arrive at 1 reported value.Data will be collected by tracking the number of sessions attended for IBBT-4 vs. the number of sessions attended for the treatment as usual group at 8 weeks post initial assessment as well as whether or not referrals to community mental health providers are successfully completed by either group at each time point.
Screen for Childhood Anxiety Related Emotional Disorders (SCARED)
The SCARED will be repeated self-report measures of anxiety symptoms at each time point to assess symptomatology. SCARED is a 41-item screening tool with each scored from 0 to 2, with 2 denoting "very true or often true" (highest value). Total scores of 25 or greater indicate the presence of an Anxiety Disorder. Subscore cut off ranges are also provided for Panic Disorder or Significant Somatic Symptoms, Generalized Anxiety Disorder, Separation Anxiety, Social Anxiety, and School Avoidance.
Children's Global Assessment Scale (CGAS)
A Children's Global Assessment Scale (CGAS) will also be completed at baseline and at each time point for global psychosocial functioning.C-GAS is rated from 0 to 100, where 1 represents the most impaired functioning and 100 represents superior functioning.
Columbia Suicide Severity Rating Scale (C-SSRS)
At baseline screening, the Columbia Suicide Severity Rating Scale (C-SSRS) will be used to assess for suicidal ideation or actions.CSSRS consists of ten categories and have binary responses (yes/no). A "yes" answer at any time during treatment to Categories 1-5 is defined as suicidal ideation. A "yes" answer at any time during treatment to Categories 6-10 is defined as suicidal behavior. A "yes" answer to any one of the ten suicidal ideation and behavior questions at any time during treatment to (Categories 1-10) is defined as suicidal ideation or behavior.

Secondary Outcome Measures

IBD disease activity - Pediatric Ulcerative Colitis Activity Index (PUCAI)
IBD disease activity will be assessed through validated Pediatric Ulcerative Colitis Activity Index (PUCAI) which measure symptom severity in a given time period through physician, laboratory, and subjective self-report markers of disease activity. These measures will be assessed at each time point. PUCAI score ranges from 0 to 85; a score of < 10 denotes remission, 10-34 indicates mild disease, 35-64 indicates moderate disease, and 65-85 indicates severe disease.
IBD-related quality of life-SIBDQ
IBD-related quality of life will be measured by the Short Quality of Life Questionnaire for Inflammatory Bowel Disease (SIBDQ).
Medical Adherence Measure
Medical Treatment Adherence will be measured by the Medical Adherence Measure (MAM).
Health Care Utilization
Health care utilization will be measured by outpatient and emergency room visits and inpatient hospitalizations collected through medical record review and participant self-report.
Pediatric Crohn's Disease Activity Index (PCDAI)
IBD disease activity will be assessed through validated Pediatric Crohn's Disease Activity Index (PCDAI) which measure symptom severity in a given time period through physician, laboratory, and subjective self-report markers of disease activity.The PCDAI has hematocrit, Albumin and ESR as markers:ESR: 0-20 mm/hr, Albumin: 3.5 - 5.0 gm/dL, HCT: 35-47%. As for the disease indicators: PCDAI score can range from 0-100, with higher scores signifying more active disease. A score of < 10 is consistent with inactive disease, 11-30 indicates mild disease, and > 30 is moderate-to-severe disease.
Health Care Cost
Health Care costs will be measured by outpatient and emergency room visits and inpatient hospitalizations collected through medical record review and participant self-report.

Full Information

First Posted
February 24, 2016
Last Updated
December 4, 2018
Sponsor
NYU Langone Health
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1. Study Identification

Unique Protocol Identification Number
NCT02740309
Brief Title
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

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Withdrawn
Why Stopped
PI left Institution
Study Start Date
April 2016 (Actual)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
March 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Integrated Brief Behavior Therapy (IBBT) Intervention
Arm Type
Experimental
Arm Description
4-sessions of IBBT for youth anxiety and depression.
Arm Title
Treatment as usual
Arm Type
Active Comparator
Arm Description
Treatment as usual
Intervention Type
Behavioral
Intervention Name(s)
Integrated Brief Behavior Therapy (IBBT) Intervention
Intervention Description
The 4 sessions will empower and support families and youth to continue treatment autonomously with home practice
Intervention Type
Behavioral
Intervention Name(s)
Treatment as usual
Intervention Description
Facilitated community referral for mental health treatment
Primary Outcome Measure Information:
Title
Change in Anxiety and/or Depression Symptoms
Description
Anxiety and depression symptoms are hypothesized to decrease more in the IBBT-4 group and psychosocial functioning is hypothesized to improve more in the IBBT-4 group as compared to TAU. The number of patients who no longer meet criteria for depression and/or anxiety after brief intervention is hypothesized to be greater than as compared to TAU. The Patient Health Questionnaire (PHQ-9) will be repeated self-report measures of depression and anxiety symptoms at each time point to assess symptomatology.The PHQ-9 consists of 9 questions scored 0-3, with 3 denoting the early every day ( highest value).
Time Frame
1 year ( baseline, 8-12 weeks, 6 months, and 12 months post baseline)
Title
Treatment Engagement at Baseline
Description
One visit is the modal number of encounters for patients seeking treatment in the community mental health care settings. The investigators hypothesize that by implementing an integrated behavioral health model that identifies mental health issues in medical settings as part of routine care and engages individuals in on-site treatment for depression and anxiety will increase the number of completed mental health encounters utilized and the number of successful referrals to community mental health providers when ongoing treatment is needed. Multiple measurements will be aggregated to arrive at 1 reported value.Data will be collected by tracking the number of sessions attended for IBBT-4 vs. the number of sessions attended for the treatment as usual group at 8 weeks post initial assessment as well as whether or not referrals to community mental health providers are successfully completed by either group at each time point.
Time Frame
1 year
Title
Screen for Childhood Anxiety Related Emotional Disorders (SCARED)
Description
The SCARED will be repeated self-report measures of anxiety symptoms at each time point to assess symptomatology. SCARED is a 41-item screening tool with each scored from 0 to 2, with 2 denoting "very true or often true" (highest value). Total scores of 25 or greater indicate the presence of an Anxiety Disorder. Subscore cut off ranges are also provided for Panic Disorder or Significant Somatic Symptoms, Generalized Anxiety Disorder, Separation Anxiety, Social Anxiety, and School Avoidance.
Time Frame
1 year
Title
Children's Global Assessment Scale (CGAS)
Description
A Children's Global Assessment Scale (CGAS) will also be completed at baseline and at each time point for global psychosocial functioning.C-GAS is rated from 0 to 100, where 1 represents the most impaired functioning and 100 represents superior functioning.
Time Frame
1 year
Title
Columbia Suicide Severity Rating Scale (C-SSRS)
Description
At baseline screening, the Columbia Suicide Severity Rating Scale (C-SSRS) will be used to assess for suicidal ideation or actions.CSSRS consists of ten categories and have binary responses (yes/no). A "yes" answer at any time during treatment to Categories 1-5 is defined as suicidal ideation. A "yes" answer at any time during treatment to Categories 6-10 is defined as suicidal behavior. A "yes" answer to any one of the ten suicidal ideation and behavior questions at any time during treatment to (Categories 1-10) is defined as suicidal ideation or behavior.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
IBD disease activity - Pediatric Ulcerative Colitis Activity Index (PUCAI)
Description
IBD disease activity will be assessed through validated Pediatric Ulcerative Colitis Activity Index (PUCAI) which measure symptom severity in a given time period through physician, laboratory, and subjective self-report markers of disease activity. These measures will be assessed at each time point. PUCAI score ranges from 0 to 85; a score of < 10 denotes remission, 10-34 indicates mild disease, 35-64 indicates moderate disease, and 65-85 indicates severe disease.
Time Frame
1 year ( Data will be collected at 4 time points: baseline, 8-12 weeks, 6 months, and 12 months post baseline)
Title
IBD-related quality of life-SIBDQ
Description
IBD-related quality of life will be measured by the Short Quality of Life Questionnaire for Inflammatory Bowel Disease (SIBDQ).
Time Frame
1 year ( Data will be collected at 4 time points: baseline, 8-12 weeks, 6 months, and 12 months post baseline)
Title
Medical Adherence Measure
Description
Medical Treatment Adherence will be measured by the Medical Adherence Measure (MAM).
Time Frame
1 year ( Data will be collected at 4 time points: baseline, 8-12 weeks, 6 months, and 12 months post baseline)
Title
Health Care Utilization
Description
Health care utilization will be measured by outpatient and emergency room visits and inpatient hospitalizations collected through medical record review and participant self-report.
Time Frame
1 year ( Data will be collected at 4 time points: baseline, 8-12 weeks, 6 months, and 12 months post baseline)
Title
Pediatric Crohn's Disease Activity Index (PCDAI)
Description
IBD disease activity will be assessed through validated Pediatric Crohn's Disease Activity Index (PCDAI) which measure symptom severity in a given time period through physician, laboratory, and subjective self-report markers of disease activity.The PCDAI has hematocrit, Albumin and ESR as markers:ESR: 0-20 mm/hr, Albumin: 3.5 - 5.0 gm/dL, HCT: 35-47%. As for the disease indicators: PCDAI score can range from 0-100, with higher scores signifying more active disease. A score of < 10 is consistent with inactive disease, 11-30 indicates mild disease, and > 30 is moderate-to-severe disease.
Time Frame
1 year ( Data will be collected at 4 time points: baseline, 8-12 weeks, 6 months, and 12 months post baseline)
Title
Health Care Cost
Description
Health Care costs will be measured by outpatient and emergency room visits and inpatient hospitalizations collected through medical record review and participant self-report.
Time Frame
1 year ( Data will be collected at 4 time points: baseline, 8-12 weeks, 6 months, and 12 months post baseline)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
K. Ron-Li Liaw, MD
Organizational Affiliation
NYU Langone
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sala Institute for Child and Family Centered Care
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Available IPD and Supporting Information:
Available IPD/Information Type
Sala Institute for Child & Family Centered Care
Available IPD/Information URL
http://nyulangone.org/locations/hassenfeld-childrens-hospital/sala-institute-for-child-family-centered-care
Available IPD/Information Identifier
Sala Institute

Learn more about this trial

Integrated Behavioral Health Innovations in Childhood Chronic Illness Care Delivery Systems

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