Partners in Caring for Anxious Youth

NCT04598230 | Active Not Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: 20203537
• Study Type: interventional
• Target: 468
• Locations: 1 country
• Sites: 3

Brief 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 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.

Conditions

Anxiety, Separation; Anxiety, Generalized; Anxiety, Social

Keywords

anxiety disorders; child; adolescent; pediatric; cognitive behavioral therapy; selective serotonin reuptake inhibitor; antidepressant medication

Outcome Measures

Primary 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.

  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.

  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 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)

  Change in CAIS-R rating of anxiety related impairment from baseline to 12 months post treatment

Study Arms (2)

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).

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

Behavioral: Cognitive Behavioral Therapy (CBT)

Interventions

Cognitive Behavioral Therapy (CBT) BEHAVIORAL

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.

Also known as: CBT, psychotherapy

Cognitive behavioral therapy (CBT); Combination therapy (COMB)

Combination therapy (COMB) DRUG

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)

Also known as: SSRI plus CBT, COMB

Combination therapy (COMB)

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• 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.
• Fluoxetine
• mg for at least 6 of 10 weeks in children \<12 year
• mg for at least 6 of 10 weeks in adolescents \>12 years
• Sertraline
• for at least 6 of 10 weeks in children \<12 years

Sponsors & Collaborators

• Ann & Robert H Lurie Children's Hospital of Chicago: lead
• University of Cincinnati: collaborator
• University of California, Los Angeles: collaborator

Study Sites (3)

UCLA Semel Institute for Neuroscience and Human Behavior

Los Angeles, California, 45219, United States

Location

Lurie Children's Hospital and Affiliated Pediatric Practices

Chicago, Illinois, 60611, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45219, United States

Location

Related Publications (5)

• 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.

  PMID: 18974308 RESULT

• Piacentini 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.

  PMID: 24565357 RESULT

• Peris 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.

  PMID: 25486372 RESULT

• Strawn 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.

  PMID: 28384010 RESULT

• Rynn 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.

  PMID: 25721183 RESULT

MeSH Terms

Conditions

Anxiety, Separation; Generalized Anxiety Disorder; Anxiety Disorders

Interventions

Cognitive Behavioral Therapy; Psychotherapy; Combined Modality Therapy; Selective Serotonin Reuptake Inhibitors

Condition Hierarchy (Ancestors)

Mental Disorders; Neurodevelopmental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Behavioral Disciplines and Activities; Therapeutics; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Neurotransmitter Agents; Serotonin Agents; Physiological Effects of Drugs

Study Officials

• John Walkup, MD

  Chair, Pritzker Department of Psychiatry and Behavioral Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department Chair Pritzker Department of Psychiatry

Study Record Dates

• First Submitted: September 23, 2020
• First Posted: October 22, 2020
• Study Start: February 9, 2021
• Primary Completion: August 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 18, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The data will be deposited in a PCORI designated repository within 3 years after the study has been completed and after acceptance of the by PCORI of the Final Research Report or publication of the key outcome paper(s) in a peer reviewed journal - which ever comes first.
• Access Criteria: Individual investigators or teams of investigators seeking access to data from PCORI-funded studies must complete and submit a data request form to a PCORI-designated repository. The repository will independently review requests for data based on qualifications of the data requestors and the scientific merit of the request

Locations

US (3)