Kids FACE FEARS Comparative Effectiveness Research

Study Overview
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Brief Summary
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The Kids FACE FEARS (Kids Face-to-face And Computer-Enhanced Formats Effectiveness study for Anxiety and Related Symptoms) is a large-scale, streamlined, pragmatic Randomized Controlled Trial (RCT) evaluating face-to-face (therapist led office based or telehealth) vs. self-administered online cognitive-behavioral therapy (CBT) for the treatment of child and adolescent anxiety. Families will be recruited from pediatric health centers serving primarily racial/ethnic minority youth in urban, suburban, and semi-rural regions. Patient-centered outcomes will be evaluated across a one-year follow-up period; parents, patients, providers, and other key stakeholders will be actively engaged throughout all aspects of the research.

Detailed Description
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Anxiety disorders are among the most common and impairing psychiatric disorders to affect children and adolescents. Cognitive Behavioral Therapy (CBT) is an effective psychological treatment for youth anxiety, with roughly 60-80% of youth showing considerable clinical response and global improvements in functioning. Regrettably, despite the existence of well-supported treatments, most youth with anxiety disorders do not receive any form of treatment, especially in resource poor settings. The pediatric health care setting offers an optimal public health venue for youth anxiety management, yet there is a critical lack of behavioral health specialty care providers who are trained in providing mental health treatment, and a lack of information on the optimal methods of treating anxiety in pediatric settings. Two evidence-based strategies for delivering CBT for youth with mild to moderate anxiety in pediatric settings are (1) face-to-face CBT delivered by therapists within pediatric health care in an office-based setting or via telehealth and (2) online delivery of CBT skills to youth and families. Importantly, however, there are no data on the relative effectiveness of these two treatment formats in real-world settings, and no information on which patient subgroups benefit most from which formats in patients in real-world practice. The study design entails a large-scale, streamlined, pragmatic, Randomized Controlled Trial (RCT), in which eligible anxious youth presenting to pediatric primary care settings will be randomly assigned to face-to-face versus online Cool Kids suite of CBT intervention for youth anxiety and monitored for up to one year post-intervention. Outcomes for each participant will be monitored across four assessment points, corresponding to baseline, mid-treatment, post-treatment, and 1 year post-baseline. Long-term outcomes associated with face-to-face versus online CBT will be evaluated over a 1-year period post-intervention. We will use the well-established Cool Kids suite of face-to-face and online anxiety CBT protocols within pediatric primary care networks serving primarily racial-ethnic minority children in both urban and rural settings across four regions of the US: the Northeast, the Mid-Atlantic, the Southeast, and the Pacific Northwest. Therapists embedded within pediatric primary care settings and mental health clinics co-located with primary care will provide all services. All participants will be identified and referred for enrollment from pediatric health settings. This study addresses three critical yet unanswered questions related to improving the delivery of treatment and outcomes for anxiety in pediatric primary care. Answering the following question offers the potential to meaningfully improve the quality of the evidence available to help children, families, and organizational stakeholders make informed decisions regarding clinical practice and implementation strategies for the treatment of childhood anxiety: What is the relative effectiveness of implementing therapist-led (face-to-face or telehealth) versus self-administered online formats of CBT to treat youth anxiety in pediatric health care? How do factors such as clinical severity, treatment preference, socioeconomic status, computer literacy, distance to clinic, organizational readiness, or medical home status moderate outcomes across treatment formats? Which patient subgroups might benefit most from which formats? What are the barriers and facilitators to delivering this care in pediatric health care settings and for the diverse patient populations served?

Official Title
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Kids Face-to-face And Computer-Enhanced Formats Effectiveness Study for Anxiety and Related Symptoms

Conditions
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Child Anxiety, Anxiety Disorder of Adolescence

Intervention / Treatment
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* Behavioral: Therapist-led Face-to-Face Cognitive-Behavioral Therapy
* Behavioral: Digital Cognitive-Behavioral Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Children age 7-18 years at the time of screening Child has elevated anxiety as indicated by a T-score above 55 (greater than 0.5 SD (Standard Deviation) above the mean) on the PROMIS Item Bank v2.0 - Anxiety - Short Form 8a (child self-report or parent proxy report) in English or Spanish at the time of screening Parent or legal guardian is fluent in English or Spanish Child's parent or legal guardian is age 16 or older If child taking SSRI/Pharmacotherapy for anxiety, must be on stable dose for greater than or equal to 8 weeks from the time of screening (self-reported, must be reported by parent if under the age of 18) Hired therapists or program staff at primary care sites or co-located sites participating in the study Exclusion Criteria Severe anxiety, as indicated by suicidal thoughts or behaviors (requiring higher level of care in the past 6 months) and/or poor functioning defined as anxiety-related inability to attend school 50% of days in the past month (or, if summer, the last month of school attended), or requiring higher level of care as determined by a clinician Required psychiatric hospitalization or residential care in the past 3 months History of diagnosed severe autism spectrum disorder (not verbal) or intellectual disability (self-reported, must be reported by parent if under the age of 18 or by primary care physician) Currently undergoing cognitive behavioral therapy or planning to continue a different psychotherapy for anxiety during the time of the study (self-reported, must be reported by parent if under the age of 18) Treatment participants not fluent in English or Spanish If over the age of 12, child has had a problem with drugs and/or alcohol within the past 6 months or at the time of screening (self-reported, must be reported by parent if under the age of 18) Cognitively impaired youth will not be included based on clinical judgment at the time of screening (Primary care staff will be consulted at time of referral) Child is ward of the state

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Web-based CBT<br>The online, multimedia suite of Cool Kids CBT web-based programs for youth anxiety is a supported, largely self-administered online digital cognitive-behavioral therapy anxiety management intervention, with adjunctive therapist phone support. Treatment content runs directly parallel to that included in the therapist-led Cool Kids face-to-face suite of interventions. The online suite of interventions is comprised of two developmentally tailored programs, depending on the age of the child. | Behavioral: Digital Cognitive-Behavioral Therapy<br>* Participants receiving digital cognitive-behavioral therapy will complete an online, largely self-administered CBT program for up to 16 weeks with 8 modules and adjunctive therapist phone support. Treatment modules focus on psychoeducation about anxiety, thought challenging and cognitive restructuring, somatic management skills training, youth exposure to feared stimuli, family patterns associated with the maintenance of youth anxiety, and contingent reinforcement.<br>|
| Active Comparator: Face-to-Face CBT<br>The Cool Kids suite of face-to-face (office-based or telehealth) CBT-based programs for youth anxiety is a well-supported therapist-led, clinic-based anxiety management intervention. The face-to-face cognitive-behavioral therapy treatment content runs directly parallel to that included in the Cool Kids online suite of interventions. The face-to-face suite of interventions is comprised of two developmentally tailored programs, depending on the age of the child. | Behavioral: Therapist-led Face-to-Face Cognitive-Behavioral Therapy<br>* Participants receiving face-to-face cognitive-behavioral therapy will participate in therapist-led, office-based or telehealth CBT treatment for up to 16 weeks. Sessions focus on psychoeducation about anxiety, thought challenging and cognitive restructuring, somatic management skills training, youth exposure to feared stimuli, family patterns associated with the maintenance of youth anxiety, and contingent reinforcement.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Promis Pediatric Short Form Item Bank v. 2.0-Anxiety | This screening form is a publicly available self-report and parent proxy measure that assesses youth fear, anxiety, misery, hyper-arousal, and somatic symptoms related to arousal. It also assesses behavioral fear avoidance. The form is available in English and Spanish and has excellent reliability and validity. The form includes 8 items and uses a scale of 1-5 (1=Never, 2=Almost never, 3= Sometimes, 4=Often, 5=Almost always). The raw score is the sum of the points for each response. A higher than average raw score indicates higher than average anxiety. A higher score represents higher levels of anxiety. | Change from Baseline, Week 8, Week 16, and Year 1 | 
| Child Anxiety Life Interference Scale (CALIS) | The Child Anxiety Life Interference Scale (CALIS) is a parent and child-report measure of life interference and impairment associated with child anxiety. The CALIS has demonstrated strong psychometric properties, and assesses impairments in family, peer, academic, and extracurricular life domains. The CALIS consists of one 10-item scale administered to children, and two 9-item scales administered to parents. All items, which relate to common activities (e.g. being with friends outside of school or your career choice), are rated on a five-point Likert scale (0 = not at all, 4 = a great deal), with higher scores indicating higher anxiety life interference. | Change from Baseline, Week 8, Week 16, and Year 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Beliefs and Attitudes about Technology as a Child Health Resource (BATCH-R) | The Beliefs and Attitudes about Technology as a Child Health Resource (BATCH-R) is a brief self-report that assesses ones perspectives on the acceptability and trustworthiness of technology-based resources for child health and development. The BATCH-R has a parent version that used to assess parent's attitudes on the use of technology for the child and an adolescent version that assesses their attitudes on the use of technology for their own care. The report includes 7 items that are rated on a 0-5 scale with 0 being strongly disagree and 5 being strongly agree. High BATCH-R scores reflect great openness to, and trust in, technology-based child health resources, whereas low BATCH-R scores reflect limited openness to, and poor trust in, technology-based child health resources. | Baseline, Week 16 | 
| Pediatric Symptom Checklist (PSC-17) | The Pediatric Symptom Checklist (PSC) is a brief screening questionnaire that is used by pediatricians and other health professionals to improve the recognition and treatment of psychosocial problems in children. We will utilize the 17-item version of the PSC which has been validated and used successfully to detect youth with psychosocial impairment.91-93 The PSC-17 includes internalizing, externalizing, and attention problems subscales, is available in Spanish and English, and has published clinical cut points. The PSC-17 consists of 17 items that are rated as Never, Sometimes,  or Often present. A value of 0 is assigned to Never, 1 to Sometimes, and 2 to Often. The total score is calculated by adding together the score for each of the 17 items. A PSC-17 score of 15 or higher suggests the presence of significant behavioral or emotional problems. | Change from Baseline, Week 8, Week 16, and Year 1 | 
| TCU Organizational Readiness for Change (ORC-D4) scale | The Organizational Readiness for Change (ORC-D4) scale is a widely used and validated self-administered measure of staff needs, motivational factors, program resources, and organizational climate that is completed by program staff. Part A of the scale has 33 items; part B has 31 items; part C has 31 items, and part D has 30 items. Each item is rated 1-5 (1= Disagree strongly, 2= Disagree, 3= Uncertain, 4= Agree, 5= Agree strongly). The average score is calculated for each part of the scale and compared to the national averages to assess the organization's readiness for change. | Baseline, An average of 1 year | 
| Depression, Anxiety, Stress Scale (DASS-21) | The Depression, Anxiety, Stress Scale (DASS-21) is a well-validated self-report questionnaire that assesses three domains of negative affect: depression, anxiety, and stress. The DASS-21 is widely used in both research and clinical settings and has demonstrated very strong psychometrics properties. The questionnaire includes 21 items that are rated on a scale of 0-3 (0= Did not apply to me at all, 1= Applied to me to some degree, or some of the time, 2= Applied to me to a considerable degree or a good part of time, 3= Applied to me very much or most of the time). Scores for depression, anxiety and stress are calculated by summing the scores for the relevant items. Scores are multiplied by 2 to calculate the final score. In each domain, scores indicate mild, moderate, severe, and extremely severe depression anxiety or stress. | Change from Baseline, Week 8, Week 16, and Year 1 | 
| Satisfaction Questionnaire | The Satisfaction Questionnaire is a measure developed by the study Investigators to understand patients' perceptions of the value of services received. The questionnaire includes 3 items that are rated on a scale of 1-4 (1= Quite Dissatisfied, 2= Indifferent or mildly dissatisfied , 3= Mostly Satisfied, 4= Very Satisfied). Higher scores indicate more satisfaction with the program. | Week 8, Week 16 | 
| Therapist Session and Post-Treatment Forms | Therapists and RAs will keep systematic logs monitoring patient attendance/module completion and homework compliance. Attendance (number of sessions attended/modules completed), number of missed/rescheduled sessions/incomplete modules, number of sessions ended early, homework compliance. | Week 1-16 | 
| Intervention Barriers and Appraisal Form | The Intervention Barriers and Appraisal Form is a parent and youth self-report that measures barriers to treatment participant during treatment and after the completion of treatment. This questionnaire also assesses perceived treatment effectiveness, patient engagement, and therapeutic alliance. The measure was developed by study investigators and includes 14 items rated on a scale of 1-7. | Week 8, Week 16 | 
| Evidence-Based Practice Attitudes Scale (EBPAS) Short Form | The short form of the Evidence-Based Practice Attitude Scale (EBPAS) is a brief 15- item therapist report of mental health provider attitudes toward adoption of evidencebased practices. Items assess individual differences in perceived appeal of evidencebased practices, openness to new practices, and perceived divergence of evidencebased practices from usual practices. The items are rated on a scale of 0-4 (0= Not at all, 1= To a slight extent, 2= To a moderate extent, 3= To a great extent, 4= To a very great extent). A higher total score indicate a more positive attitude towards adoption of evidence-based practice. | Baseline, An average of 1 year | 
| The Clinical Global Impression - Improvement Scale | The Clinical Global Impression - Improvement Scale (CGI-I) measures the patient's level of clinical improvement relative to the patient's severity at the beginning of treatment. This is a single item scale that is rated on a scale from 1-7 (1= Very Much Improved, 2= Much Improved, 3= Minimally Improved, 4= No Change, 5= Minimally Worse, 6= Much Worse, 7= Very Much Worse). | Change between sessions, Week 8, Week 16, Year 1 | 
| Technological Ease and Computer-based Habits Inventory (TECHI) | The Technological Ease and Computer-based Habits Inventory (TECHI) is a self-report that assesses frequency of technology use (including desktop, Internet, and mobile technologies), confidence in ones technological skills and ability to problem-solve technology-related issues), and frustration with technology-based complications. The measure has 20 items rated on a scale of 1-5 (1= Strongly Disagree, 5= Strongly Agree). | Baseline, An average of 1 year | 
| Pediatric Rating Scale (PARS) | The Pediatric Rating Scale (PARS) is a clinician-rated instrument for assessing the frequency and severity of anxiety symptoms associated with common anxiety disorders (social phobia, separation anxiety disorder, and generalized anxiety disorder) in children between the ages of 6 and 17. It has 50 symptom items and 7 severity items. The PARS has shown high interrater reliability (ICC = 0.97), adequate test-retest reliability (α = .64), and fair internal consistency (ICC = 0.55). | Change from Baseline, Week 16 | 
| Sleep Item | The Sleep Item is a one-item parent- and child-report of measuring sleep-related difficulties on a 5-point Likert scale. | Change from Baseline, Week 8, Week 16, Year 1 | 
| Parental Attitudes, Beliefs, and Understanding of Anxiety (PABUA) - Overprotection Scale | The Parental Attitudes, Beliefs, and Understanding of Anxiety (PABUA) - Overprotection Scale is a parent-self report that evaluates parents' attitudes and beliefs about their child's anxiety. The Overprotection Scale further examines parental perceived beliefs and behaviors around overprotection as well as tolerance of distress and avoidance. This is an 11-item measure scored on a scale from 1-5 (1= Strongly Disagree, 2= Disagree Somewhat, 3= Neither Agree or Disagree, 4= Agree Somewhat, 5= Strongly Agree). | Change from Baseline, Week 8, Week 16, Year 1 | 
| Technology Experience and Attitude Rating Scale 1.0 (TEARS 1.0) | The Technology Experience and Attitude Rating Scale 1.0 (TEARS 1.0) is a 5-item parent-, child-, and therapist-report that evaluates the impact of technology (i.e., videoconferencing and telehealth) complications on intervention quality, usefulness, and frustrations when completing therapist-led treatments. Each item is rated on a scale from 1-5 (1= Strongly Disagree, 5= Strongly Agree). This measure is administered to participants randomized to the therapist-led face-to-face arm of the study. | Change between sessions, Week 16, Year 1 | 
| Technology Experience and Attitudes Rating Scale 2.0 (TEARS 2.0) | The Technology Experience and Attitude Rating Scale 2.0 (TEARS 2.0) is a 5-item parent- and child-report that evaluates the impact of technology-based complications on intervention quality, usefulness, and frustrations when completing computer-based treatments.Each item is rated on a scale from 1-5 (1= Strongly Disagree, 5= Strongly Agree). This measure is administered to participants randomized to the self-administered online arm of the study. | Change between sessions, Week 16, Year 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognitive Behavioral Therapy (CBT), Face to face CBT, Online CBT, Telehealth, Anxiety, Child