Anxiety, SeparationPhase 3PCAYNCT04598230
Partners in Caring for Anxious Youth
A Phase 3 study testing Cognitive Behavioral Therapy (CBT) and Combination therapy (COMB) in people with Anxiety, Separation and Anxiety, Generalized, run by Ann & Robert H Lurie Children's Hospital of Chicago at 3 sites in United States.
Trial summary
Pediatric onset anxiety disorders (generalized anxiety, social anxiety, separation anxiety) are highly prevalent, and if untreated, are impairing into adolescence and adulthood. In the largest comparative efficacy study remission occurred in about 65% of children and adolescents treated with a combination of a… Read more about this study
- Who is it for?
- Ages 7 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Separation, Anxiety, Generalized, Anxiety, Social
- What is being tested?
- Cognitive Behavioral Therapy (CBT) and Combination therapy (COMB)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 468 participants
- Where
- 3 sitesUnited States
- Study dates
- 9 Feb 2021to 1 Dec 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Child
Who may be able to join
- Ages 7-17 years (inclusive at time of consent/assent)
- Primary Diagnostic and Statistical Manual, 5th Edition (DSM-5) diagnosis of separation anxiety disorder (SAD), and/or generalized anxiety disorder (GAD), and/or social anxiety disorder (SocAD) as determined by self-reported structured interview (MINI-KID) and confirmation by a study clinician.
- Stable/treated Attention Deficit Hyperactivity Disorder (ADHD), combined or hyperactive impulsive subtypes
- An available primary caretaker with ongoing patient contact who is legally able to provide consent
- Medically cleared by a pediatric clinician including a negative urine pregnancy test for females of child-bearing age. Furthermore, female patients must agree to abstain from sexual activity or to use a reliable method of birth control as determined by pediatric clinician during the study.
Who cannot join
- Patients with the following lifetime psychiatric disorders: moderate to severe autism, bipolar disorder, schizophrenia, or schizoaffective disorder, history of intellectual disability
- Primary Attention Deficit Hyperactivity Disorder (ADHD), combined or hyperactive impulsive subtypes
- Major depressive disorder with greater severity than anxiety disorder requiring treatment not provided in PCAY
- Obsessive Compulsive Disorder (OCD) only (no co-occurring SAD, SocAD or GAD)
- Patients with a major medical illness that would interfere with participation in the study (e.g., complex, and evolving medical treatments, or require frequent hospitalizations).
- Patients who are pregnant as indicated by a positive pregnancy test or are sexually active and not using effective birth control.
Show all 29Show fewer
- Patients who pose a significant and imminent risk to self or to others.
- Patients who experienced minimal or no change an adequate dose of evidenced-based medication treatment or CBT for their anxiety disorder.
- (See medication and CBT exclusions below)
- Patients or caregiver(s) who do not speak English or Spanish. All materials and treatments will be available in Spanish and English.
- Children and adolescents with complex psychiatric needs that cannot be managed in primary care and community settings as determined by study local Principal Investigator (PI) and provider teams.
- Medication Exclusions
- Fluoxetine
- 20 mg for at least 6 of 10 weeks in children <12 year
- 40 mg for at least 6 of 10 weeks in adolescents >12 years
- Sertraline
- 100 for at least 6 of 10 weeks in children <12 years
- 150 for at least 6 of 10 weeks in adolescents >12 years
- Citalopram
- 20 mg for at least 6 of 10 weeks in children >12 years
- 30 mg for at least 6 of 10 weeks adolescent > 12 years
- Escitalopram
- 10 mg for at least 6 of 10 weeks in children <12 years
- 20 mg for at least 6 of 10 weeks in adolescent >12 years
- Fluvoxamine
- 150 mg for at least 6 of 10 weeks in children <12 years
- 200 mg for at least 6 of 10 weeks in children < 12 year
- CBT Exclusions
- Failed a previous trial of verified CBT for anxiety disorders within the previous year judged adequate by ≥12 exposure-based CBT sessions
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Lurie Children's Hospital and Affiliated Pediatric Practices
Chicago, Illinois, 60611
University of Cincinnati
Cincinnati, Ohio, 45219
UCLA Semel Institute for Neuroscience and Human Behavior
Los Angeles, California, 45219
About this study
Pediatric onset anxiety disorders (generalized anxiety, social anxiety, separation anxiety) are highly prevalent, and if untreated, are impairing into adolescence and adulthood. In the largest comparative efficacy study remission occurred in about 65% of children and adolescents treated with a combination of a selective serotonin reuptake inhibitors (SSRI) and cognitive behavioral therapy (CBT). In contrast, CBT without an SSRI achieved remission in 35% of children at 3 months and 45% at 6 months-a 30% and 20% difference, respectively. Despite the difference in remission rates, CBT alone is the preferred treatment of most patients and families. Lack of awareness of the significant difference in remission rates and concerns about medication side effects may drive patient and family preference even though SSRIs have a positive safety profile.
Critiques of CBT in the above study suggest that CBT was not as effective as it could be due to short treatment duration, restricted family involvement and limited exposure sessions. Would the combination of CBT and an SSRI still be superior to CBT only, if CBT was of longer duration, and included more family involvement and exposure sessions?
In the Partners in Care for Anxious Youth (PCAY) study, children and adolescents with an anxiety disorder ages 7-17 years followed in pediatric primary care clinics affiliated with three institution: Lurie Children's Hospital of Chicago, University of California Los Angeles and University of Cincinnati will be randomized to one of two treatment arms; either CBT only or CBT combined with an SSRI (either fluoxetine, sertraline, or escitalopram). CBT in PCAY will be 6 months in duration and include more family involvement, and more exposure opportunities than past trials. The 6-month acute treatment phase will be followed by 6 months of followup. The primary outcome will be anxiety symptom remission and reduction in impairment over 6 and 12-months.
Read the detailed description
Anxiety disorders begin during childhood and adolescents, are extremely common, but are often under-diagnosed and under-treated. If untreated, pediatric anxiety disorders can be chronic and impairing into adulthood. The good news is that evidence-based treatments can be highly effective in reducing symptoms, and for a good number of children and adolescents, treatment can reduce anxiety symptoms to a minimum with marked improvement in function. In the largest comparative efficacy study, remission (minimal or no symptoms of anxiety), occurred in about 65% of children and adolescents treated with a combination of a selective serotonin reuptake inhibitor (SSRI) and cognitive behavioral therapy (CBT). In contrast, CBT without an SSRI achieved remission in 35% of children at 3 months and 45% at 6 months-a 30% and 20% difference, respectively.
Nonetheless, CBT alone is the preferred treatment of most patients and families. Lack of awareness of the significant difference in remission rates and concerns about medication side effects may drive patient and family preference, even though SSRIs have a positive safety profile.
In the study described above, CBT was limited in ways that might account for why it was less effective. CBT was shorter in duration, had fewer sessions, and less exposure opportunities than it was originally designed to have and had less family involvement than more current approaches. Given that patients and families prefer CBT, it is important to know if combination of CBT and an SSRI is truly superior to CBT only or whether fully implemented CBT can close the gap in remission rates with the combination of CBT and an SSRI. The study will also provide information about which children and adolescents achieve remission with CBT or CBT and an SSRI.
The Partners in Caring for Anxious Youth (PCAY) study will screen children and adolescents ages 7-17 years in pediatric primary care clinics affiliated with three institution: Lurie Children's Hospital of Chicago, University of California Los Angeles and University of Cincinnati. If a child screens positive with symptoms of an anxiety disorder, the patient and family will be offered an opportunity to learn about PCAY. If the family is interested in PCAY, a study staff person will provide information and answer any questions. If the patient and family want to enroll they will sign a consent form, complete an evaluation, and if eligible and willing to move forward, be randomized to either CBT or CBT plus an SSRI. The study team will work with the patient and family to connect to a therapist in the community to start CBT and if medication is part of treatment, work with the patient's pediatrician to begin medication. CBT will include up to 20 session of therapy and medication treatment will be a selective serotonin reuptake inhibitor (either fluoxetine, sertraline or escitalopram). The goal of treatment is for the child or adolescent with an anxiety disorder to reach remission and have a marked improvement in functioning. The first part of treatment lasts 6 months and there is then ongoing follow-up for an additional 6 months (12 months total). When the study is finished, the investigators hope to know if CBT and an SSRI is really superior to fully implemented CBT or not. The results of this study will inform patients, families, providers, payors and policy makers on the value of medication when combined with CBT.
- Conditions
- Anxiety, Separation, Anxiety, Generalized, Anxiety, Social
- Being tested
- Cognitive Behavioral Therapy (CBT), Combination therapy (COMB)
- Keywords
- anxiety disorders, child, adolescent, pediatric, cognitive behavioral therapy, selective serotonin reuptake inhibitor, antidepressant medication
- Medical subject headings
- Anxiety, Separation, Generalized Anxiety Disorder, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy (CBT)Behavioural
Also called CBT, psychotherapy
Participants randomized to this arm will receive up to 20 sessions of evidence based cognitive behavioral therapy (CBT) of extended duration, with more exposure tasks and greater family involvement than has been studied in the past.
Combination therapy (COMB)Drug
Also called SSRI plus CBT, COMB
Participants randomized to this arm will receive cognitive behavioral therapy comparable to that in the cognitive behavioral therapy arm, plus one of three selective serotonin reuptake inhibitors (SSRI) medications (fluoxetine, sertraline, escitalopram)
| Study group | Role | What they receive |
|---|---|---|
| Combination therapy (COMB) | Active comparator | Participants randomized to this arm will receive cognitive behavioral therapy and one of three study medications (fluoxetine, sertraline, or escitalopram). Receives: Behavioral: Cognitive Behavioral Therapy (CBT); Drug: Combination therapy (COMB) |
| Cognitive behavioral therapy (CBT) | Active comparator | Participants randomized to this arm will receive cognitive behavioral therapy (CBT) only Receives: Behavioral: Cognitive Behavioral Therapy (CBT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Global Impression-Severity Scale (CGI-S)
The CGI-S score provides a global rating of anxiety symptom severity ranging from 1 (not at all ill) to 7 (extremely ill). The CGI-S is commonly used in clinical trials and will allow us to benchmark across prior studies in the field.
Measured: The primary outcome is anxiety disorder remission based on a parent- and child-reported CGI-S rating of 1 (not at all ill) or 2 (borderline ill) at 6 months from first treatment visit
Child Anxiety Impairment Scale-Revised (CAIS-R)
The CAIS-R is a 47-item parent- and child-reported rating of the degree to which anxiety symptoms are impairing the child or adolescent's functioning. Scores range from 0-141 with higher scores indicate poorer functioning.
Measured: Change in CAIS-R rating of anxiety-related impairment from baseline to 6 months post treatment
Secondary outcomes (2)
Clinical Global Impression-Severity Scale (CGI-S)
The CGI-S score provides a global rating of anxiety symptom severity ranging from 1 (not at all ill) to 7 (extremely ill). The CGI-S is commonly used in clinical trials and will allow us to benchmark across prior studies in the field.
Measured: The primary outcome is anxiety disorder remission based on a parent- and child-reported CGI-S rating of 1 (not at all ill) or 2 (borderline ill) at 12 months from first treatment visit
Child Anxiety Impairment Scale-Revised (CAIS-R)
The CAIS-R is a 47-item parent- and child-reported rating of the degree to which anxiety symptoms are impairing the child or adolescent's functioning. Scores range from 0-141 with higher scores indicate poorer functioning.
Measured: Change in CAIS-R rating of anxiety related impairment from baseline to 12 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start9 Feb 2021
- Primary completion31 Aug 2025
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Anxiety, SeparationStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 468 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cincinnati, University of California, Los Angeles
- Responsible party
- Principal investigator, John T Walkup, MD, Ann & Robert H Lurie Children's Hospital of Chicago
- Investigators
- John Walkup, MD, Principal investigator, Chair, Pritzker Department of Psychiatry and Behavioral Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04598230
- Sponsor's protocol ID
- 20203537
- Acronym
- PCAY
- Status last verified
- Apr 2026
- First submitted
- 23 Sep 2020
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The final cleaned and locked data set that contains all the data used in conducting the analyses reported in the in the Patient Centered Outcome Research Institute (PCORI) Final Research Report and is fully de-identified in accordance with the the HIPAA Rule. These data include all baseline demographic and diagnostic data, baseline anxiety measures and repeated anxiety measures across the acute phase of the study. The data set will allow for replicating the primary outcomes and baseline moderators of the study's primary outcome. The data will be deposited in a PCORI designated repository within 3 years after the study has been completed and after acceptance by PCORI of the Final Research Report or publication of the key outcome paper(s) in a peer reviewed journal - whichever comes first.
Publications
Walkup JT, Albano AM, Piacentini J, Birmaher B, Compton SN, Sherrill JT, Ginsburg GS, Rynn MA, McCracken J, Waslick B, Iyengar S, March JS, Kendall PC. Cognitive behavioral therapy, sertraline, or a combination in childhood anxiety. N Engl J Med. 2008 Dec 25;359(26):2753-66. doi: 10.1056/NEJMoa0804633. Epub 2008 Oct 30.
PubMed 18974308Piacentini J, Bennett S, Compton SN, Kendall PC, Birmaher B, Albano AM, March J, Sherrill J, Sakolsky D, Ginsburg G, Rynn M, Bergman RL, Gosch E, Waslick B, Iyengar S, McCracken J, Walkup J. 24- and 36-week outcomes for the Child/Adolescent Anxiety Multimodal Study (CAMS). J Am Acad Child Adolesc Psychiatry. 2014 Mar;53(3):297-310. doi: 10.1016/j.jaac.2013.11.010. Epub 2013 Nov 28.
PubMed 24565357Peris TS, Compton SN, Kendall PC, Birmaher B, Sherrill J, March J, Gosch E, Ginsburg G, Rynn M, McCracken JT, Keeton CP, Sakolsky D, Suveg C, Aschenbrand S, Almirall D, Iyengar S, Walkup JT, Albano AM, Piacentini J. Trajectories of change in youth anxiety during cognitive-behavior therapy. J Consult Clin Psychol. 2015 Apr;83(2):239-52. doi: 10.1037/a0038402. Epub 2014 Dec 8.
PubMed 25486372Strawn JR, Dobson ET, Mills JA, Cornwall GJ, Sakolsky D, Birmaher B, Compton SN, Piacentini J, McCracken JT, Ginsburg GS, Kendall PC, Walkup JT, Albano AM, Rynn MA. Placebo Response in Pediatric Anxiety Disorders: Results from the Child/Adolescent Anxiety Multimodal Study. J Child Adolesc Psychopharmacol. 2017 Aug;27(6):501-508. doi: 10.1089/cap.2016.0198. Epub 2017 Apr 6.
PubMed 28384010Rynn MA, Walkup JT, Compton SN, Sakolsky DJ, Sherrill JT, Shen S, Kendall PC, McCracken J, Albano AM, Piacentini J, Riddle MA, Keeton C, Waslick B, Chrisman A, Iyengar S, March JS, Birmaher B. Child/Adolescent anxiety multimodal study: evaluating safety. J Am Acad Child Adolesc Psychiatry. 2015 Mar;54(3):180-90. doi: 10.1016/j.jaac.2014.12.015. Epub 2014 Dec 31.
PubMed 25721183
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Partners in Caring for Anxious Youth
- ClinicalTrials.gov ID
- NCT04598230
- Acronym / sponsor ID
- PCAY / 20203537
- Conditions
- Anxiety, Separation, Anxiety, Generalized, Anxiety, Social
- Keywords
- anxiety disorders, child, adolescent, pediatric, cognitive behavioral therapy, selective serotonin reuptake inhibitor, antidepressant medication
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 468 participants (estimated)
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of ChicagoUniversity, hospital or other
- Collaborators
- University of Cincinnati, University of California, Los Angeles
- Study start
- 9 Feb 2021 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 22 Oct 2020 (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.
Pediatric onset anxiety disorders (generalized anxiety, social anxiety, separation anxiety) are highly prevalent, and if untreated, are impairing into adolescence and adulthood. In the largest comparative efficacy study remission occurred in about 65% of children and adolescents treated with a combination of a selective serotonin reuptake inhibitors (SSRI) and cognitive behavioral therapy (CBT). In contrast, CBT without an SSRI achieved remission in 35% of children at 3 months and 45% at 6 months-a 30% and 20% difference, respectively. Despite the difference in remission rates, CBT alone is the preferred treatment of most patients and families. Lack of awareness of the significant difference in remission rates and concerns about medication side effects may drive patient and family preference even though SSRIs have a positive safety profile.
Critiques of CBT in the above study suggest that CBT was not as effective as it could be due to short treatment duration, restricted family involvement and limited exposure sessions. Would the combination of CBT and an SSRI still be superior to CBT only, if CBT was of longer duration, and included more family involvement and exposure sessions?
In the Partners in Care for Anxious Youth (PCAY) study, children and adolescents with an anxiety disorder ages 7-17 years followed in pediatric primary care clinics affiliated with three institution: Lurie Children's Hospital of Chicago, University of California Los Angeles and University of Cincinnati will be randomized to one of two treatment arms; either CBT only or CBT combined with an SSRI (either fluoxetine, sertraline, or escitalopram). CBT in PCAY will be 6 months in duration and include more family involvement, and more exposure opportunities than past trials. The 6-month acute treatment phase will be followed by 6 months of followup. The primary outcome will be anxiety symptom remission and reduction in impairment over 6 and 12-months.
Detailed description
Anxiety disorders begin during childhood and adolescents, are extremely common, but are often under-diagnosed and under-treated. If untreated, pediatric anxiety disorders can be chronic and impairing into adulthood. The good news is that evidence-based treatments can be highly effective in reducing symptoms, and for a good number of children and adolescents, treatment can reduce anxiety symptoms to a minimum with marked improvement in function. In the largest comparative efficacy study, remission (minimal or no symptoms of anxiety), occurred in about 65% of children and adolescents treated with a combination of a selective serotonin reuptake inhibitor (SSRI) and cognitive behavioral therapy (CBT). In contrast, CBT without an SSRI achieved remission in 35% of children at 3 months and 45% at 6 months-a 30% and 20% difference, respectively.
Nonetheless, CBT alone is the preferred treatment of most patients and families. Lack of awareness of the significant difference in remission rates and concerns about medication side effects may drive patient and family preference, even though SSRIs have a positive safety profile.
In the study described above, CBT was limited in ways that might account for why it was less effective. CBT was shorter in duration, had fewer sessions, and less exposure opportunities than it was originally designed to have and had less family involvement than more current approaches. Given that patients and families prefer CBT, it is important to know if combination of CBT and an SSRI is truly superior to CBT only or whether fully implemented CBT can close the gap in remission rates with the combination of CBT and an SSRI. The study will also provide information about which children and adolescents achieve remission with CBT or CBT and an SSRI.
The Partners in Caring for Anxious Youth (PCAY) study will screen children and adolescents ages 7-17 years in pediatric primary care clinics affiliated with three institution: Lurie Children's Hospital of Chicago, University of California Los Angeles and University of Cincinnati. If a child screens positive with symptoms of an anxiety disorder, the patient and family will be offered an opportunity to learn about PCAY. If the family is interested in PCAY, a study staff person will provide information and answer any questions. If the patient and family want to enroll they will sign a consent form, complete an evaluation, and if eligible and willing to move forward, be randomized to either CBT or CBT plus an SSRI. The study team will work with the patient and family to connect to a therapist in the community to start CBT and if medication is part of treatment, work with the patient's pediatrician to begin medication. CBT will include up to 20 session of therapy and medication treatment will be a selective serotonin reuptake inhibitor (either fluoxetine, sertraline or escitalopram). The goal of treatment is for the child or adolescent with an anxiety disorder to reach remission and have a marked improvement in functioning. The first part of treatment lasts 6 months and there is then ongoing follow-up for an additional 6 months (12 months total). When the study is finished, the investigators hope to know if CBT and an SSRI is really superior to fully implemented CBT or not. The results of this study will inform patients, families, providers, payors and policy makers on the value of medication when combined with CBT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combination therapy (COMB) | Active comparator | Behavioral: Cognitive Behavioral Therapy (CBT), Drug: Combination therapy (COMB)Participants randomized to this arm will receive cognitive behavioral therapy and one of three study medications (fluoxetine, sertraline, or escitalopram). |
| Cognitive behavioral therapy (CBT) | Active comparator | Behavioral: Cognitive Behavioral Therapy (CBT)Participants randomized to this arm will receive cognitive behavioral therapy (CBT) only |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Ages 7-17 years (inclusive at time of consent/assent)
- Primary Diagnostic and Statistical Manual, 5th Edition (DSM-5) diagnosis of separation anxiety disorder (SAD), and/or generalized anxiety disorder (GAD), and/or social anxiety disorder (SocAD) as determined by self-reported structured interview (MINI-KID) and confirmation by a study clinician.
- Stable/treated Attention Deficit Hyperactivity Disorder (ADHD), combined or hyperactive impulsive subtypes
- An available primary caretaker with ongoing patient contact who is legally able to provide consent
- Medically cleared by a pediatric clinician including a negative urine pregnancy test for females of child-bearing age. Furthermore, female patients must agree to abstain from sexual activity or to use a reliable method of birth control as determined by pediatric clinician during the study.
Key exclusion criteria (29 listed)
- Patients with the following lifetime psychiatric disorders: moderate to severe autism, bipolar disorder, schizophrenia, or schizoaffective disorder, history of intellectual disability
- Primary Attention Deficit Hyperactivity Disorder (ADHD), combined or hyperactive impulsive subtypes
- Major depressive disorder with greater severity than anxiety disorder requiring treatment not provided in PCAY
- Obsessive Compulsive Disorder (OCD) only (no co-occurring SAD, SocAD or GAD)
- Patients with a major medical illness that would interfere with participation in the study (e.g., complex, and evolving medical treatments, or require frequent hospitalizations).
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)Also: CBT, psychotherapyParticipants randomized to this arm will receive up to 20 sessions of evidence based cognitive behavioral therapy (CBT) of extended duration, with more exposure tasks and greater family involvement than has been studied in the past. | Behavioural | Cognitive behavioral therapy (CBT), Combination therapy (COMB) |
| Combination therapy (COMB)Also: SSRI plus CBT, COMBParticipants randomized to this arm will receive cognitive behavioral therapy comparable to that in the cognitive behavioral therapy arm, plus one of three selective serotonin reuptake inhibitors (SSRI) medications (fluoxetine, sertraline, escitalopram) | Drug | Combination therapy (COMB) |
Primary outcome
Clinical Global Impression-Severity Scale (CGI-S)
Time frame: The primary outcome is anxiety disorder remission based on a parent- and child-reported CGI-S rating of 1 (not at all ill) or 2 (borderline ill) at 6 months from first treatment visit
The CGI-S score provides a global rating of anxiety symptom severity ranging from 1 (not at all ill) to 7 (extremely ill). The CGI-S is commonly used in clinical trials and will allow us to benchmark across prior studies in the field.
Child Anxiety Impairment Scale-Revised (CAIS-R)
Time frame: Change in CAIS-R rating of anxiety-related impairment from baseline to 6 months post treatment
The CAIS-R is a 47-item parent- and child-reported rating of the degree to which anxiety symptoms are impairing the child or adolescent's functioning. Scores range from 0-141 with higher scores indicate poorer functioning.
2 secondary outcomes
Clinical Global Impression-Severity Scale (CGI-S)
Time frame: The primary outcome is anxiety disorder remission based on a parent- and child-reported CGI-S rating of 1 (not at all ill) or 2 (borderline ill) at 12 months from first treatment visit
Child Anxiety Impairment Scale-Revised (CAIS-R)
Time frame: Change in CAIS-R rating of anxiety related impairment from baseline to 12 months post treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Results publication: PubMed 18974308Walkup JT, Albano AM, Piacentini J, Birmaher B, Compton SN, Sherrill JT, Ginsburg GS, Rynn MA, McCracken J, Waslick B, Iyengar S, March JS, Kendall PC. Cognitive behavioral therapy, sertraline, or a combination in childhood anxiety. N Engl J Med. 2008 Dec 25;359(26):2753-66. doi: 10.1056/NEJMoa0804633. Epub 2008 Oct 30.
- Results publication: PubMed 24565357Piacentini J, Bennett S, Compton SN, Kendall PC, Birmaher B, Albano AM, March J, Sherrill J, Sakolsky D, Ginsburg G, Rynn M, Bergman RL, Gosch E, Waslick B, Iyengar S, McCracken J, Walkup J. 24- and 36-week outcomes for the Child/Adolescent Anxiety Multimodal Study (CAMS). J Am Acad Child Adolesc Psychiatry. 2014 Mar;53(3):297-310. doi: 10.1016/j.jaac.2013.11.010. Epub 2013 Nov 28.
- Results publication: PubMed 25486372Peris TS, Compton SN, Kendall PC, Birmaher B, Sherrill J, March J, Gosch E, Ginsburg G, Rynn M, McCracken JT, Keeton CP, Sakolsky D, Suveg C, Aschenbrand S, Almirall D, Iyengar S, Walkup JT, Albano AM, Piacentini J. Trajectories of change in youth anxiety during cognitive-behavior therapy. J Consult Clin Psychol. 2015 Apr;83(2):239-52. doi: 10.1037/a0038402. Epub 2014 Dec 8.
- Results publication: PubMed 28384010Strawn JR, Dobson ET, Mills JA, Cornwall GJ, Sakolsky D, Birmaher B, Compton SN, Piacentini J, McCracken JT, Ginsburg GS, Kendall PC, Walkup JT, Albano AM, Rynn MA. Placebo Response in Pediatric Anxiety Disorders: Results from the Child/Adolescent Anxiety Multimodal Study. J Child Adolesc Psychopharmacol. 2017 Aug;27(6):501-508. doi: 10.1089/cap.2016.0198. Epub 2017 Apr 6.
- Results publication: PubMed 25721183Rynn MA, Walkup JT, Compton SN, Sakolsky DJ, Sherrill JT, Shen S, Kendall PC, McCracken J, Albano AM, Piacentini J, Riddle MA, Keeton C, Waslick B, Chrisman A, Iyengar S, March JS, Birmaher B. Child/Adolescent anxiety multimodal study: evaluating safety. J Am Acad Child Adolesc Psychiatry. 2015 Mar;54(3):180-90. doi: 10.1016/j.jaac.2014.12.015. Epub 2014 Dec 31.
- Individual participant dataSharing planned: Yes. The final cleaned and locked data set that contains all the data used in conducting the analyses reported in the in the Patient Centered Outcome Research Institute (PCORI) Final Research Report and is fully de-identified in accordance with the the HIPAA Rule. These data include all baseline demographic and diagnostic data, baseline anxiety measures and repeated anxiety measures across the acute phase of the study. The data set will allow for replicating the primary outcomes and baseline moderators of the study's primary outcome. The data will be deposited in a PCORI designated repository within 3 years after the study has been completed and after acceptance by PCORI of the Final Research Report or publication of the key outcome paper(s) in a peer reviewed journal - whichever comes first.
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Social Anxiety Disorder, Separation Anxiety Disorder
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.
John Walkup, MD principal investigator
Chair, Pritzker Department of Psychiatry and Behavioral Health
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cognitive Behavioral Therapy (CBT) and Combination therapy (COMB) in people with Anxiety, Separation and Anxiety, Generalized, run by Ann & Robert H Lurie Children's Hospital of Chicago at 3 sites 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 5 inclusion and 29 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: under way, not looking for participants, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Clinical Global Impression-Severity Scale (CGI-S) (time frame: The primary outcome is anxiety disorder remission based on a parent- and child-reported CGI-S rating of 1 (not at all ill) or 2 (borderline ill) at 6 months from first treatment visit). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04598230, which also lists 5 linked publications.
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 1 Jul 2026; AzTrials last refreshed its copy on 1 Nov 2026.