AnxietyNCT04931199
A Mobile Health Solution for Homework During CBT
A study testing Cognitive Behavioral Therapy (CBT) and CBT+App in people with Anxiety and Depression, run by University of South Florida at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Anxiety, Depression, Posttraumatic Stress Disorder
- What is being tested?
- Cognitive Behavioral Therapy (CBT) and CBT+App
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jun 2021to 31 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Providers:
- English-speaking
- Mental health providers who have obtained at least a master's degree in social work, counseling, clinical psychology, or related field
- Carry active child mental health treatment caseloads
- Have a laptop, tablet, or smartphone with internet access
- Youth:
Show all 15Show fewer
- English-speaking
- Youth Ages 7-17 years
- Clinically elevated anxiety and depression as indicated by a T-score ≥ 65 on the Revised Children's Anxiety and Depression Scale-25 Child Version (RCADS-25-Y) and/or Revised Children's Anxiety and Depression Scale-25 Parent Version (RCADS-25-P) or total score ≥ 15 on the Child and Adolescent Trauma Screen - Youth Report (CATS-Y) and/or Child and Adolescent Trauma Screen - Caregiver Report (CATS-P)
- Have a laptop, tablet, or smartphone with internet access
- Caregivers:
- English-speaking
- Adult (≥18 years old)
- Caregivers of a youth who meets eligibility criteria
- Have internet and smartphone access.
Who cannot join
- Youth with self- or caregiver-reported:
- Active psychotic symptoms (e.g., hallucinations, delusions)
- Significant cognitive disability, developmental delays, or pervasive developmental disorder.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Mobile Health Solution to Improve Between-Session Skills Practice in Youth Mental Health Treatment
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.
- Conditions
- Anxiety, Depression, Posttraumatic Stress Disorder
- Being tested
- Cognitive Behavioral Therapy (CBT), CBT+App
- Keywords
- mhealth, mental health, youth mental health, adolescent mental health, homework
- Medical subject headings
- Anxiety Disorders, Depression, Stress Disorders, Post-Traumatic, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy (CBT)Behavioural
The standard of care procedures for children with clinically elevated anxiety, depression, and PTSD is traditional CBT from their mental health provider.
CBT+AppBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| CBT | Active comparator | Not described Receives: Behavioral: Cognitive Behavioral Therapy (CBT) |
| CBT+App | Experimental | Not described Receives: Behavioral: CBT+App |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6-Months Post-Baseline
Secondary outcomes (22)
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.
Measured: Weekly between Baseline and 3-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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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:
Measured: 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
Measured: 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
Measured: 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
Measured: 3-Months Post-Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start10 Jun 2021
- Primary completion31 Aug 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04931199
- Sponsor's protocol ID
- 002313
- Other IDs
- K23MH118482
- Status last verified
- Dec 2023
- First submitted
- 2 Jun 2021
- Last updated
- 20 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mobile Health Solution to Improve Between-Session Skills Practice in Youth Mental Health Treatment
- ClinicalTrials.gov ID
- NCT04931199
- Acronym / sponsor ID
- 002313
- Conditions
- Anxiety, Depression, Posttraumatic Stress Disorder
- Keywords
- mhealth, mental health, youth mental health, adolescent mental health, homework
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 10 Jun 2021 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 18 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBT | Active comparator | Behavioral: Cognitive Behavioral Therapy (CBT) |
| CBT+App | Experimental | Behavioral: CBT+App |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (15 listed)
- English-speaking
- Mental health providers who have obtained at least a master's degree in social work, counseling, clinical psychology, or related field
- Carry active child mental health treatment caseloads
- Have a laptop, tablet, or smartphone with internet access
- English-speaking
Key exclusion criteria (3 listed)
- Active psychotic symptoms (e.g., hallucinations, delusions)
- Significant cognitive disability, developmental delays, or pervasive developmental disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral Therapy (CBT)The standard of care procedures for children with clinically elevated anxiety, depression, and PTSD is traditional CBT from their mental health provider. | Behavioural | CBT |
| CBT+AppParticipants 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. | Behavioural | CBT+App |
Primary outcome
Revised Children's Anxiety and Depression Scale-25 Child Version (RCADS-25-Y)
Time frame: Baseline
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.
Revised Children's Anxiety and Depression Scale-25 Child Version (RCADS-25-Y)
Time frame: 3-Months Post-Baseline
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.
Revised Children's Anxiety and Depression Scale-25 Child Version (RCADS-25-Y)
Time frame: 6-Months Post-Baseline
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.
Revised Children's Anxiety and Depression Scale-25 Parent Version (RCADS-25-P)
Time frame: Baseline
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.
Revised Children's Anxiety and Depression Scale-25 Parent Version (RCADS-25-P)
Time frame: 3-Months Post-Baseline
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.
Revised Children's Anxiety and Depression Scale-25 Parent Version (RCADS-25-P)
Time frame: 6-Months Post-Baseline
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.
Child and Adolescent Trauma Screen - Youth Report (CATS-Y)
Time frame: Baseline
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.
Child and Adolescent Trauma Screen - Youth Report (CATS-Y)
Time frame: 3-Months Post-Baseline
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.
Child and Adolescent Trauma Screen - Youth Report (CATS-Y)
Time frame: 6-Months Post-Baseline
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.
Child and Adolescent Trauma Screen - Caregiver Report (CATS-P)
Time frame: Baseline
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.
Child and Adolescent Trauma Screen - Caregiver Report (CATS-P)
Time frame: 3-Months Post-Baseline
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.
Child and Adolescent Trauma Screen - Caregiver Report (CATS-P)
Time frame: 6-Months Post-Baseline
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.
22 secondary outcomes
Homework Rating Scale II (HRS II)
Time frame: Weekly between Baseline and 3-Months Post-Baseline
Homework Adherence and Competence Scale (HAACS)
Time frame: Weekly between Baseline and 3-Months Post-Baseline
Child and Adolescent Disruptive Behavior Inventory (CADBI)
Time frame: Baseline
Child and Adolescent Disruptive Behavior Inventory (CADBI)
Time frame: 3-Months Post-Baseline
Child and Adolescent Disruptive Behavior Inventory (CADBI)
Time frame: 6-Months Post-Baseline
KIDSCREEN-10 Index Child and Adolescent Version (KIDSCREEN-10-Y)
Time frame: Baseline
KIDSCREEN-10 Index Child and Adolescent Version (KIDSCREEN-10-Y)
Time frame: 3-Months Post-Baseline
KIDSCREEN-10 Index Child and Adolescent Version (KIDSCREEN-10-Y)
Time frame: 6-Months Post-Baseline
KIDSCREEN-10 Index Parent Version (KIDSCREEN-10-P)
Time frame: Baseline
KIDSCREEN-10 Index Parent Version (KIDSCREEN-10-P)
Time frame: 3-Months Post-Baseline
KIDSCREEN-10 Index Parent Version (KIDSCREEN-10-P)
Time frame: 6-Months Post-Baseline
Generalized Anxiety Disorder-7 (GAD-7)
Time frame: Baseline
Generalized Anxiety Disorder-7 (GAD-7)
Time frame: 3-Months Post-Baseline
Generalized Anxiety Disorder-7 (GAD-7)
Time frame: 6-Months Post-Baseline
Patient Health Questionnaire-8 (PHQ-8)
Time frame: Baseline
Patient Health Questionnaire-8 (PHQ-8)
Time frame: 3-Months Post-Baseline
Patient Health Questionnaire-8 (PHQ-8)
Time frame: 6-Months Post-Baseline
Working Alliance Inventory - Short Revised - Client Version (WAI-SR)
Time frame: 3-Months Post-Baseline
Child/Adolescent Satisfaction Questionnaire (CASQ-Y)
Time frame: 3-Months Post-Baseline
Caregiver Satisfaction Questionnaire (CSQ-P)
Time frame: 3-Months Post-Baseline
Attitudes Toward Homework Questionnaire (ATHQ)
Time frame: Baseline
Attitudes Toward Homework Questionnaire (ATHQ)
Time frame: 3-Months Post-Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy (CBT) and CBT+App in people with Anxiety and Depression, run by University of South Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Revised Children's Anxiety and Depression Scale-25 Child Version (RCADS-25-Y) (time frame: Baseline). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2023.