Testing Delivery Modalities of Team-Based Cognitive Behavioral Treatment (CBT) for Pediatric Anxiety in Community Health Settings: Developing Pathways to Health Equity
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 501
- 试验地点
- 1
- 主要终点
- Client Satisfaction Questionnaire-Revised (CSQ-8-R)
研究概览
简要总结
The purpose of this study is to test how the delivery of Cognitive Behavioral Therapy (CBT) for pediatric anxiety and OCD via different methods might increase its availability and effectiveness. CBT involves teaching the patient skills to enable them to gradually come into contact with feared situations. This process of gradually approaching feared situations is called exposure. Although CBT with exposure has the best evidence for treating anxiety disorders, not all children have equal access or respond the same way to CBT. As part of this study, patients will receive weekly CBT treatment sessions involving a combination of weekly visits with an exposure coach and one visit a month with a licensed provider (e.g., social worker) who also provides weekly supervision for the exposure coach. This treatment will be delivered using one of three methods: 1) in-person (face-to-face sessions, occurring in the office and the home/community), or 2) telehealth (entirely remote sessions via web-based video conference), or 3) flexible (individualized mix of in-person and/or telehealth sessions). Eligible participants will be randomly assigned to one of these three methods. Results of this study will help determine which treatment method works best for whom.
Treatment as described above will occur as part of care at partnering community care sites in Rhode Island. Providers from the following partnering community care sites will make up patient treatment teams: Blackstone Valley Community Health Care, Family Services of Rhode Island, Gateway Healthcare, Newport Mental Health, and Thrive Behavioral Health.
The research study is being conducted by the Pediatric Anxiety Research Center at Brown University Health. The research team will conduct the study assessments that patients will be asked to participate in as study participants. Patients will be asked to complete assessments prior to starting treatment, at two time points during treatment, at the end of treatment, and at two timepoints 3 and 6 months following the end of treatment. Participants will be compensated for their time completing research assessments.
详细描述
Anxiety disorders are a significant public health problem that cause suffering for youth and their families, derail normal childhood development, and when left untreated persist into adulthood with high societal costs. Cognitive Behavioral Treatment (CBT) including exposure therapy is the treatment of choice, yet multiple barriers limit access to care. Youth from historically marginalized groups face even greater barriers to accessing high-quality care, including limited availability and inconvenience of services, transportation difficulties, lower mental health literacy, and experiences of stigmatization and discrimination. Systematic reviews consistently show comparable outcomes for in-person vs. telehealth treatment for anxiety yet results highlight the lack of rigorous comparative research in understanding which patient subgroups are more likely to benefit from different delivery modalities, making the process of selecting among them more confusing than ever for families. In the wake of the COVID-19 pandemic, using a flexible service modality (i.e., custom mix of telehealth and in-person sessions) has also become common practice. The question of how best to improve access to high quality care is particularly relevant in community health settings (e.g., Certified Community Behavioral Health Centers (CCBHCs) and Federally Qualified Health Centers (FQHCs)) that serve a high proportion of vulnerable youth due to the staggering and longstanding failure to include these youth in clinical trials and the clear need to tailor treatment to better address barriers to access, quality, and clinical improvement. The overall goal of this proposal is to compare three modalities for delivering outpatient exposure-based CBT in youth ages 5-18 using existing care teams in CCBHC/FQHC ("safety net") settings: in-person (traditional face-to-face sessions only, occurring in the office and home/community) vs. telehealth (only occurring remotely via web-based video conference) vs. flexible (tailored mix of telehealth and/or in-person sessions). A total of 501 children with anxiety and/or OCD will be treated, with 167 children randomly assigned to each of the treatment conditions. A trained independent evaluator (IE) masked to condition will measure patient and family treatment engagement, anxiety symptoms/severity, and functional impairment at baseline, during active treatment at weeks 8, 16, and 24, and 3- and 6-month follow-up after acute treatment. The primary aims are to compare the relative effectiveness of in-person vs. telehealth vs. flexible CBT for: reducing anxiety-related functional impairment, improving family treatment engagement, improving family satisfaction, reducing barriers to treatment access, and maintaining treatment quality. Secondary outcomes are to understand predictors of pre- to post-treatment change in functional impairment including severity of illness, caregiver burden, and family accommodation and to explore group differences in time course of response and durability of treatment gains. Longer-term goals include establishing a service delivery model that can be scaled nationally in similar practice settings. Primary outcomes are driven by real world needs of patients and families and selected in collaboration with stakeholders. The approach for all aims will involve regression of the outcome variable on treatment group (flexible vs in-person or telehealth), randomization stratification factors (minoritized race/ethnicity, site), a small number of pre-specified covariates that are hypothesized to be strongly associated with the outcome (age, poverty), and baseline value of the outcome, as appropriate. This is the ANCOVA approach to analysis in randomized controlled trials. Missing data will be handled with multiple imputation using chained equations. In secondary analyses, we will evaluate the potential impact of missing data and assumptions regarding the relationship of missing data mechanisms and treatment effect estimates using sensitivity analyses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 5-18 inclusive
- •Primary or co-primary DSM-V diagnosis of anxiety or OCD
- •Symptom duration of at least 3 months
- •Outpatient care needed
- •Presence of a stable parent, or guardian, who can participate in treatment
排除标准
- •Other primary or co-primary psychiatric disorder which requires initiation of other active current treatment
- •Acute suicidality
- •Concurrent psychotherapy
- •Chronic medical illness that would preclude their active participation in treatment
- •Treatment with psychotropic medication that is not stable
研究组 & 干预措施
Flexible
Families and providers will collaboratively choose treatment delivery modality (in-person versus telehealth) on a session-by-session basis.
干预措施: Team-delivered, exposure-based CBT (Behavioral)
In-person
Families will only attend sessions in-person. Sessions may occur at the family's home, in the community, or in the provider's office.
干预措施: Team-delivered, exposure-based CBT (Behavioral)
Telehealth
Families will only attend sessions via a secure remote video platform.
干预措施: Team-delivered, exposure-based CBT (Behavioral)
结局指标
主要结局
Client Satisfaction Questionnaire-Revised (CSQ-8-R)
时间窗: Week 8, Week 16 and follow-up (6 & 12 months)
The CSQ-8-R measures consumer satisfaction with mental health services; satisfaction is measured using 8 items on a scale from 1 (Poor) to 4 (Excellent). Total satisfaction ranges from 8-32, with a high score indicating greater satisfaction.
Exposure Guide
时间窗: Weekly at Week 1 through 24.
The Exposure Guide is an empirically-supported exposure therapy fidelity/quality tool completed by study therapists. It measures exposure quality, including: therapist use of specific strategies that predict clinical improvement, exposure completion, exposure difficulty, therapeutic learning, barriers to completion, and engagement.
Pediatric Anxiety Rating Scale (PARS)
时间窗: Baseline, Week 8, Week 16 and follow-up (6 & 12 months)
The PARS is a measure of anxiety symptoms and severity. The Anxiety Severity Items are 7 questions meant to assess the frequency of anxiety symptoms and associated impairment. Items are measured on a scale from 0 (none) to 5 (extreme).The total range of anxiety severity is reported on a scale from 0-35, with a higher score indicating greater severity.
Clinical Global Impression Scales
时间窗: Baseline, Week 8, Week 16 and follow-up (6 & 12 months)
The CGI is a clinician-rated measures of global severity and improvement. The Severity of illness scale reports the severity of current symptoms on a scale from 1 (not at all ill) to 7 (among the most extremely ill patients.) The Global Improvement Scale tracks improvement since treatment initiation on a scale from 1 (very much improved) to 7 (very much worse). The highest possible score on either scale is 7, indicating extreme severity or worse treatment outcome.
Top Problems Assessment
时间窗: Baseline, Week 8, Week 16 and follow-up (6 & 12 months)
The TPA is designed to independently solicit from youth and parents the top 3 problems they feel are most important to address in treatment. This is an idiographic measure of impairment that is driven by the individual needs and desires of the consumer. Respondents rate how much each problem bothers them from 0 ("not at all") to 10 (very, very much).
Child Sheehan Disability Scale (CSDS)
时间窗: Baseline, Week 8, Week 16 and follow-up (6 & 12 months)
The CSDS measures the extent to which anxiety symptoms interfere with functioning. The Disability Scale measures the degree to which anxiety impacts school, social, and home life on a scale from 0 (Not at all) to 10 (very, very much.) Total anxiety-related impairment ranges from 0-30, with higher scores indicating greater impairment.
Barriers to Treatment Questionnaire - Parent Version (BTQ-P)
时间窗: Baseline, Week 8, Week 16 and follow-up (6 & 12 months)
The BTQ-P is a 28-item measure adapted from the BTQ to assess parent perceptions of barriers to accessing treatment for their child's anxiety. The measure is completed at the outset of treatment and assesses such domains as logistic and financial barriers, stigma, and aspects of treatment. Items are rated on a 0 ("not at all true") to 2 ("mostly true") scale.
Top Problems Assessment- Caregiver report
时间窗: Baseline, Week 8, Week 16 and follow-up (6 & 12 months)
The TPA is designed to independently solicit from youth and parents the top 3 problems they feel are most important to address in treatment. This is an idiographic measure of impairment that is driven by the individual needs and desires of the consumer. Respondents rate how much each problem bothers them from 0 ("not at all") to 10 (very, very much).
Child Sheehan Disability Scale (CSDS)- caregiver report
时间窗: Baseline, Week 8, Week 16 and follow-up (6 & 12 months)
The CSDS measures the extent to which anxiety symptoms interfere with functioning. The Disability Scale measures the degree to which anxiety impacts school, social, and home life on a scale from 0 (Not at all) to 10 (very, very much.) Total anxiety-related impairment ranges from 0-30, with higher scores indicating greater impairment.
Client Satisfaction Questionnaire-Revised (CSQ-8-R)
时间窗: Week 8, Week 16 and follow-up (6 & 12 months)
The CSQ-8-R measures consumer satisfaction with mental health services; satisfaction is measured using 8 items on a scale from 1 (Poor) to 4 (Excellent). Total satisfaction ranges from 8-32, with a high score indicating greater satisfaction.
Exposure Guide
时间窗: Weekly at Week 1 through 24.
The Exposure Guide is an empirically-supported exposure therapy fidelity/quality tool completed by study therapists. It measures exposure quality, including: therapist use of specific strategies that predict clinical improvement, exposure completion, exposure difficulty, therapeutic learning, barriers to completion, and engagement.
Children's Yale-Brown Obsessive-Compulsive Scale Second Edition: (CY-BOCS II)
时间窗: Baseline, Week 8, Week 16 and follow-up (6 & 12 months)
The CY-BOCS II is a measure of obsessive-compulsive symptoms and their severity. The Obsession Rating Scale assesses five domains of obsessional severity, each scored from 0 (no impairment) to 5 (extreme impairment). The Compulsion Rating Scale assesses five domains of compulsion severity using the same 0-5 scale. The total OCD severity score ranges from 0 to 50, with higher scores indicating greater symptom severity.
Pediatric Anxiety Rating Scale (PARS)
时间窗: Baseline, Week 8, Week 16 and follow-up (6 & 12 months)
The PARS is a measure of anxiety symptoms and severity. The Anxiety Severity Items are 7 questions meant to assess the frequency of anxiety symptoms and associated impairment. Items are measured on a scale from 0 (none) to 5 (extreme).The total range of anxiety severity is reported on a scale from 0-35, with a higher score indicating greater severity.
Clinical Global Impression Scales
时间窗: Baseline, Week 8, Week 16 and follow-up (6 & 12 months)
The CGI is a clinician-rated measures of global severity and improvement. The Severity of illness scale reports the severity of current symptoms on a scale from 1 (not at all ill) to 7 (among the most extremely ill patients.) The Global Improvement Scale tracks improvement since treatment initiation on a scale from 1 (very much improved) to 7 (very much worse). The highest possible score on either scale is 7, indicating extreme severity or worse treatment outcome.
Top Problems Assessment
时间窗: Baseline, Week 8, Week 16 and follow-up (6 & 12 months)
The TPA is designed to independently solicit from youth and parents the top 3 problems they feel are most important to address in treatment. This is an idiographic measure of impairment that is driven by the individual needs and desires of the consumer. Respondents rate how much each problem bothers them from 0 ("not at all") to 10 (very, very much).
Child Sheehan Disability Scale (CSDS)
时间窗: Baseline, Week 8, Week 16 and follow-up (6 & 12 months)
The CSDS measures the extent to which anxiety symptoms interfere with functioning. The Disability Scale measures the degree to which anxiety impacts school, social, and home life on a scale from 0 (Not at all) to 10 (very, very much.) Total anxiety-related impairment ranges from 0-30, with higher scores indicating greater impairment.
Barriers to Treatment Questionnaire - Parent Version (BTQ-P)
时间窗: Baseline, Week 8, Week 16 and follow-up (6 & 12 months)
The BTQ-P is a 28-item measure adapted from the BTQ to assess parent perceptions of barriers to accessing treatment for their child's anxiety. The measure is completed at the outset of treatment and assesses such domains as logistic and financial barriers, stigma, and aspects of treatment. Items are rated on a 0 ("not at all true") to 2 ("mostly true") scale.
次要结局
- Homework Compliance Form(Weekly at Week 1 though 24)
- Demographics(Baseline)
- Diagnostic Interview for Anxiety, Mood, and Obsessive-compulsive and related Neuropsychiatric Disorders (DIAMOND-Kid)(Baseline)
- Caregiver Strain Questionnaire (CSQ)(Baseline, Week 8, Week 16 and follow-up (6 & 12 months))
- Reasons for Treatment Discontinuation form(Administered only at discharge, up to 6-months into study)
- Pediatric Accommodation Scale-Parent Report (PAS-PR)(Baseline, Week 8, Week 16 and follow-up (6 & 12 months))
- Ask Suicide Screening Questions (ASQ)(Baseline, Week 8, Week 16 and follow-up (6 & 12 months))
- The Cultural Formulation Interview (CFI)(Baseline)
- Everyday Discrimination Scale (EDS)(Baseline)
- Client Satisfaction Questionnaire-Revised (CSQ-8-R)(Week 8, Week 16 and follow-up (6 & 12 months))
- Barriers to Treatment Questionnaire - Parent Version (BTQ-P)(Baseline, Week 8, Week 16 and follow-up (6 & 12 months))
- Clinical Global Impression Scales(Baseline, Week 8, Week 16 and follow-up (6 & 12 months))
- Exposure Guide(Weekly at Week 1 through 24.)
- Homework Compliance(Every session- up to 24 weeks of acute treatment)
- Youth Top Problems Assessment(Baseline, Week 8, Week 16 and follow-up (6 & 12 months))
- Youth Child Sheehan Disability Scale (CSDS)(Baseline, Week 8, Week 16 and follow-up (6 & 12 months))
- Homework Compliance Form(Weekly at Week 1 though 24)
- Demographics(Baseline)
- Diagnostic Interview for Anxiety, Mood, and Obsessive-compulsive and related Neuropsychiatric Disorders (DIAMOND-Kid)(Baseline)
- Caregiver Strain Questionnaire (CSQ)(Baseline, Week 8, Week 16 and follow-up (6 & 12 months))
- Reasons for Treatment Discontinuation form(Administered only at discharge, up to 6-months into study)
- Pediatric Accommodation Scale-Parent Report (PAS-PR)(Baseline, Week 8, Week 16 and follow-up (6 & 12 months))
- Ask Suicide Screening Questions (ASQ)(Baseline, Week 8, Week 16 and follow-up (6 & 12 months))
- The Cultural Formulation Interview (CFI)(Baseline)
- Everyday Discrimination Scale (EDS)(Baseline)
- Randomization Debrief(Administered at baseline)
- Treatment Expectancy(Administered at baseline)
- End of Treatment Form(Administered only at discharge, up to 6-months into study)