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| ID | Type | Description | Link |
|---|---|---|---|
| K23MH118482 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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The purpose of this study is to preliminarily evaluate a web-based app to improve provider implementation and patient engagement in homework (i.e., between-session practice of skills learned during therapy) during child mental health treatment by conducting a small-scale feasibility trial in community practice settings comparing Cognitive Behavioral Therapy (CBT) to CBT enhanced with the app.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CBT | Active Comparator |
| |
| CBT+App | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Behavioral Therapy (CBT) | Behavioral | The standard of care procedures for children with clinically elevated anxiety, depression, and PTSD is traditional CBT from their mental health provider. |
| Measure | Description | Time Frame |
|---|---|---|
| Revised Children's Anxiety and Depression Scale-25 Child Version (RCADS-25-Y) | The Revised Children's Anxiety and Depression Scale-25 Child Version (RCADS-25-Y) is a 25-item self-report questionnaire that assesses levels of anxiety and depression in youth. Total, Total Anxiety, and Total Depression T-scores range from 0 to >80 with higher scores reflecting greater symptom severity. | Baseline |
| Revised Children's Anxiety and Depression Scale-25 Child Version (RCADS-25-Y) | The Revised Children's Anxiety and Depression Scale-25 Child Version (RCADS-25-Y) is a 25-item self-report questionnaire that assesses levels of anxiety and depression in youth. Total, Total Anxiety, and Total Depression T-scores range from 0 to >80 with higher scores reflecting greater symptom severity. | 3-Months Post-Baseline |
| Revised Children's Anxiety and Depression Scale-25 Child Version (RCADS-25-Y) | The Revised Children's Anxiety and Depression Scale-25 Child Version (RCADS-25-Y) is a 25-item self-report questionnaire that assesses levels of anxiety and depression in youth. Total, Total Anxiety, and Total Depression T-scores range from 0 to >80 with higher scores reflecting greater symptom severity. | 6-Months Post-Baseline |
| Revised Children's Anxiety and Depression Scale-25 Parent Version (RCADS-25-P) | The Revised Children's Anxiety and Depression Scale-25 Parent Version (RCADS-25-P) is a 25-item caregiver-report questionnaire that assesses levels of anxiety and depression in youth. Total, Total Anxiety, and Total Depression T-scores range from 0 to >80 with higher scores reflecting greater symptom severity. | Baseline |
| Revised Children's Anxiety and Depression Scale-25 Parent Version (RCADS-25-P) | The Revised Children's Anxiety and Depression Scale-25 Parent Version (RCADS-25-P) is a 25-item caregiver-report questionnaire that assesses levels of anxiety and depression in youth. Total, Total Anxiety, and Total Depression T-scores range from 0 to >80 with higher scores reflecting greater symptom severity. |
| Measure | Description | Time Frame |
|---|---|---|
| Homework Rating Scale II (HRS II) | The Homework Rating Scale II (HRS II) is a 4-item self-report questionnaire that assesses levels of homework adherence in cognitive behavior therapy. Total scores range from 0 to 8 with higher scores reflecting greater homework adherence. | Weekly between Baseline and 3-Months Post-Baseline |
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Inclusion Criteria:
Providers:
Youth:
Caregivers:
Exclusion Criteria:
Youth with self- or caregiver-reported:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South Florida | Tampa | Florida | 33613 | United States |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 20, 2024 | |
| Reset | Oct 15, 2024 | |
| Release | May 22, 2025 | |
| Reset | Jun 10, 2025 | |
| Release | Dec 19, 2025 | |
| Reset | Jan 14, 2026 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 27, 2023 | Aug 14, 2023 | Prot_SAP_000.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 20, 2024 | Oct 15, 2024 | |||
| May 22, 2025 |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| D013313 | Stress Disorders, Post-Traumatic |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D040921 | Stress Disorders, Traumatic |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| CBT+App | Behavioral | Participants receive CBT as usual enhanced with a simple, HIPAA compliant, web-based application to help mental health providers implement homework during CBT with children with elevated PTSD, anxiety, and/or depression, and their caregivers. The three major components of the app help providers to (1) Practice interactive, digitized CBT exercises with patients in-session; (2) Remind patients to practice CBT exercises for homework, and (3) Review homework during the next session. |
|
| 3-Months Post-Baseline |
| Revised Children's Anxiety and Depression Scale-25 Parent Version (RCADS-25-P) | The Revised Children's Anxiety and Depression Scale-25 Parent Version (RCADS-25-P) is a 25-item caregiver-report questionnaire that assesses levels of anxiety and depression in youth. Total, Total Anxiety, and Total Depression T-scores range from 0 to >80 with higher scores reflecting greater symptom severity. | 6-Months Post-Baseline |
| Child and Adolescent Trauma Screen - Youth Report (CATS-Y) | The Child and Adolescent Trauma Screen - Youth Report (CATS-Y) is a 25-item self-report questionnaire that assesses levels of post traumatic distress in youth. Total scores range from 0 to 60 with higher scores reflecting greater symptom severity. | Baseline |
| Child and Adolescent Trauma Screen - Youth Report (CATS-Y) | The Child and Adolescent Trauma Screen - Youth Report (CATS-Y) is a 25-item self-report questionnaire that assesses levels of post traumatic distress in youth. Total scores range from 0 to 60 with higher scores reflecting greater symptom severity. | 3-Months Post-Baseline |
| Child and Adolescent Trauma Screen - Youth Report (CATS-Y) | The Child and Adolescent Trauma Screen - Youth Report (CATS-Y) is a 25-item self-report questionnaire that assesses levels of post traumatic distress in youth. Total scores range from 0 to 60 with higher scores reflecting greater symptom severity. | 6-Months Post-Baseline |
| Child and Adolescent Trauma Screen - Caregiver Report (CATS-P) | The Child and Adolescent Trauma Screen - Caregiver Report (CATS-P) is a 25-item caregiver-report questionnaire that assesses levels of post traumatic distress in youth. Total scores range from 0 to 60 with higher scores reflecting greater symptom severity. | Baseline |
| Child and Adolescent Trauma Screen - Caregiver Report (CATS-P) | The Child and Adolescent Trauma Screen - Caregiver Report (CATS-P) is a 25-item caregiver-report questionnaire that assesses levels of post traumatic distress in youth. Total scores range from 0 to 60 with higher scores reflecting greater symptom severity. | 3-Months Post-Baseline |
| Child and Adolescent Trauma Screen - Caregiver Report (CATS-P) | The Child and Adolescent Trauma Screen - Caregiver Report (CATS-P) is a 25-item caregiver-report questionnaire that assesses levels of post traumatic distress in youth. Total scores range from 0 to 60 with higher scores reflecting greater symptom severity. | 6-Months Post-Baseline |
| Homework Adherence and Competence Scale (HAACS) |
The Homework Adherence and Competence Scale (HAACS) is a 19-item independent evaluator-rated instrument that assesses therapists' adherence and competence in reviewing, designing, and assigning homework assignments in cognitive behavior therapy. Total scores range from 0 to 30 for Reviewing homework, 0 to 54 for Designing homework, and 0 to 30 for Assigning homework, with higher scores reflecting greater adherence/competence. |
| Weekly between Baseline and 3-Months Post-Baseline |
| Child and Adolescent Disruptive Behavior Inventory (CADBI) | The Child and Adolescent Disruptive Behavior Inventory (CADBI) is a 25-item caregiver-report questionnaire that assesses levels of post traumatic distress in youth. Total scores range from 0 to 200 with higher scores reflecting greater symptom severity. | Baseline |
| Child and Adolescent Disruptive Behavior Inventory (CADBI) | The Child and Adolescent Disruptive Behavior Inventory (CADBI) is a 25-item caregiver-report questionnaire that assesses levels of post traumatic distress in youth. Total scores range from 0 to 200 with higher scores reflecting greater symptom severity. | 3-Months Post-Baseline |
| Child and Adolescent Disruptive Behavior Inventory (CADBI) | The Child and Adolescent Disruptive Behavior Inventory (CADBI) is a 25-item caregiver-report questionnaire that assesses levels of post traumatic distress in youth. Total scores range from 0 to 200 with higher scores reflecting greater symptom severity. | 6-Months Post-Baseline |
| KIDSCREEN-10 Index Child and Adolescent Version (KIDSCREEN-10-Y) | The KIDSCREEN-10 Index Child and Adolescent Version (KIDSCREEN-10-Y is a 10-item self-report questionnaire that assesses levels of quality of life in youth. Total T-scores range from 0 to >80 with higher scores reflecting greater quality of life. | Baseline |
| KIDSCREEN-10 Index Child and Adolescent Version (KIDSCREEN-10-Y) | The KIDSCREEN-10 Index Child and Adolescent Version (KIDSCREEN-10-Y is a 10-item self-report questionnaire that assesses levels of quality of life in youth. Total T-scores range from 0 to >80 with higher scores reflecting greater quality of life. | 3-Months Post-Baseline |
| KIDSCREEN-10 Index Child and Adolescent Version (KIDSCREEN-10-Y) | The KIDSCREEN-10 Index Child and Adolescent Version (KIDSCREEN-10-Y is a 10-item self-report questionnaire that assesses levels of quality of life in youth. Total T-scores range from 0 to >80 with higher scores reflecting greater quality of life. | 6-Months Post-Baseline |
| KIDSCREEN-10 Index Parent Version (KIDSCREEN-10-P) | The KIDSCREEN-10 Index Parent Version (KIDSCREEN-10-P) is a 10-item caregiver-report questionnaire that assesses levels of quality of life in youth. Total T-scores range from 0 to >80 with higher scores reflecting greater quality of life. | Baseline |
| KIDSCREEN-10 Index Parent Version (KIDSCREEN-10-P) | The KIDSCREEN-10 Index Parent Version (KIDSCREEN-10-P) is a 10-item caregiver-report questionnaire that assesses levels of quality of life in youth. Total T-scores range from 0 to >80 with higher scores reflecting greater quality of life. | 3-Months Post-Baseline |
| KIDSCREEN-10 Index Parent Version (KIDSCREEN-10-P) | The KIDSCREEN-10 Index Parent Version (KIDSCREEN-10-P) is a 10-item caregiver-report questionnaire that assesses levels of quality of life in youth. Total T-scores range from 0 to >80 with higher scores reflecting greater quality of life. | 6-Months Post-Baseline |
| Generalized Anxiety Disorder-7 (GAD-7) | The Generalized Anxiety Disorder scale-7 (GAD-7) is a seven-item diagnostic tool validated in both the primary care setting and the general population | Baseline |
| Generalized Anxiety Disorder-7 (GAD-7) | The Generalized Anxiety Disorder scale-7 (GAD-7) is a seven-item diagnostic tool validated in both the primary care setting and the general population | 3-Months Post-Baseline |
| Generalized Anxiety Disorder-7 (GAD-7) | The Generalized Anxiety Disorder scale-7 (GAD-7) is a seven-item diagnostic tool validated in both the primary care setting and the general population | 6-Months Post-Baseline |
| Patient Health Questionnaire-8 (PHQ-8) | The eight-item Patient Health Questionnaire depression scale (PHQ-8) is established as a valid diagnostic and severity measure for depressive disorders in large clinical studies | Baseline |
| Patient Health Questionnaire-8 (PHQ-8) | The eight-item Patient Health Questionnaire depression scale (PHQ-8) is established as a valid diagnostic and severity measure for depressive disorders in large clinical studies | 3-Months Post-Baseline |
| Patient Health Questionnaire-8 (PHQ-8) | The eight-item Patient Health Questionnaire depression scale (PHQ-8) is established as a valid diagnostic and severity measure for depressive disorders in large clinical studies | 6-Months Post-Baseline |
| Working Alliance Inventory - Short Revised - Client Version (WAI-SR) | The Working Alliance Inventory-Short Revised (WAI-SR) is a 12-item measure for the assessment of the therapeutic alliance. | 3-Months Post-Baseline |
| Child/Adolescent Satisfaction Questionnaire (CASQ-Y) | CASQ is a 14 item questionnaire administered to children and youth involved with mental health services. It is identical to the parent version and measures three dimensions of satisfaction with mental health services: | 3-Months Post-Baseline |
| Caregiver Satisfaction Questionnaire (CSQ-P) | Client Satisfaction Questionnaire (CSQ-8) examines the level of consumer satisfaction with children's (ages 8 to 17 years) outpatient mental health services | 3-Months Post-Baseline |
| Attitudes Toward Homework Questionnaire (ATHQ) | A self-report assessing practitioners' demographic characteristics, use of homework assignments and attitudes towards the use of homework assignments in psychotherapy | Baseline |
| Attitudes Toward Homework Questionnaire (ATHQ) | A self-report assessing practitioners' demographic characteristics, use of homework assignments and attitudes towards the use of homework assignments in psychotherapy | 3-Months Post-Baseline |
| Jun 10, 2025 |
| Dec 19, 2025 | Jan 14, 2026 |
| D000068099 |
| Trauma and Stressor Related Disorders |
| D010549 | Personal Satisfaction |