Integrated Behavioral Health Innovations in Childhood Chronic Illness Care Delivery Systems

NCT02740309 | Withdrawn

• 1 other identifier: 15-01065
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (5)

• 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).

  1 year ( baseline, 8-12 weeks, 6 months, and 12 months post baseline)

• 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.

  1 year

• 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.

  1 year

• 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.

  1 year

• 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.

  1 year

Secondary Outcomes (6)

• IBD disease activity - Pediatric Ulcerative Colitis Activity Index (PUCAI)

  1 year ( Data will be collected at 4 time points: baseline, 8-12 weeks, 6 months, and 12 months post baseline)

• IBD-related quality of life-SIBDQ

  1 year ( Data will be collected at 4 time points: baseline, 8-12 weeks, 6 months, and 12 months post baseline)

• Medical Adherence Measure

  1 year ( Data will be collected at 4 time points: baseline, 8-12 weeks, 6 months, and 12 months post baseline)

• Health Care Utilization

  1 year ( Data will be collected at 4 time points: baseline, 8-12 weeks, 6 months, and 12 months post baseline)

• Pediatric Crohn's Disease Activity Index (PCDAI)

  1 year ( Data will be collected at 4 time points: baseline, 8-12 weeks, 6 months, and 12 months post baseline)

Study Arms (2)

Integrated Brief Behavior Therapy (IBBT) Intervention

EXPERIMENTAL

4-sessions of IBBT for youth anxiety and depression.

Behavioral: Integrated Brief Behavior Therapy (IBBT) Intervention

Treatment as usual

ACTIVE COMPARATOR

Treatment as usual

Behavioral: Treatment as usual

Interventions

Integrated Brief Behavior Therapy (IBBT) Intervention BEHAVIORAL

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

Integrated Brief Behavior Therapy (IBBT) Intervention

Treatment as usual BEHAVIORAL

Facilitated community referral for mental health treatment

Treatment as usual

Eligibility Criteria

• Age: 12 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

Sala Institute for Child and Family Centered Care

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Interventions

Methods; Therapeutics

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• K. Ron-Li Liaw, MD

  NYU Langone

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2016
• First Posted: April 15, 2016
• Study Start: April 1, 2016
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: December 5, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)