Generalized Anxiety Disorder (GAD)STARNCT07228143
Stepped Care Treatment for Anxiety Resilience
A study testing Relaxation and Mentorship Training (RMT) and Stepped Care Targeting Exposure and Parenting for Anxiety (STEP-A) in people with Generalized Anxiety Disorder (GAD) and Social Anxiety Disorder (SAD), run by Andrew Wiese at 1 site in United States.
Trial summary
Childhood anxiety disorders (CAD) are common and impairing. Family based cognitive behavioral therapy (CBT) is efficacious in treating CAD. Yet, many children do not receive care due to barriers such as limited provider availably, high treatment costs, and constrained family resources (e.g., time). Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Generalized Anxiety Disorder (GAD), Social Anxiety Disorder (SAD), Separation Anxiety Disorder
- What is being tested?
- Relaxation and Mentorship Training (RMT) and Stepped Care Targeting Exposure and Parenting for Anxiety (STEP-A)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jan 2026to 30 Apr 2028
- Phase
- Interventional
- 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
- No healthy volunteers
- Child
Who may be able to join
- A primary diagnosis of OCD or an anxiety disorder including separation anxiety disorder, social phobia, generalized anxiety disorder, specific phobia, agoraphobia, panic disorder, as determine by an IE using the DIAMOND-KID diagnostic interview.
- Score of ≥ 14 on the PARS (items 2-7) which corresponds to clinically significant anxiety.
- The child is 7-17 years old.
- Residence in Texas and located in the state of Texas during treatment sessions.
Who cannot join
- -Psychosis, cognitive disability, any condition that would limit the caregiver's ability to follow instructions.
- Parent substance use disorder within the past 3 months, which could impact their ability to implement step 1
- Child or parent is suicidal. A delayed entry once the parent or child is stabilized (>6 months post suicidality) and no longer has suicidal ideation will be allowed if appropriate.
- New pharmacological interventions or treatment changes: Initiation of an antidepressant within 12 weeks before study enrollment or 6 weeks for an antipsychotic, benzodiazepine, or attention deficit hyperactivity disorder (ADHD) medication before enrollment, or any change in established psychotropic medication (e.g., antidepressants, anxiolytics) within 6 weeks before study enrollment (4 weeks for antipsychotic, anti-anxiety, benzodiazepine, or ADHD medication changes). Medications will remain stable during treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jazzmine Ward, BS contact
United States1 site, 1 recruiting
- Recruiting
Baylor College of Medicine
Houston, Texas, 77030
Jazzmine Ward, BA, 713-798-3579, starstudy@bcm.edu
Andrew D Wiese, PhD
About this study
Official title: Stepped Care Cognitive Behavioral Therapy for Children and Adolescents With Anxiety
Childhood anxiety disorders (CAD) are common and impairing. Family based cognitive behavioral therapy (CBT) is efficacious in treating CAD. Yet, many children do not receive care due to barriers such as limited provider availably, high treatment costs, and constrained family resources (e.g., time). To combat these barriers, other treatment methods have been developed.
The stepped care treatment models maximize resources by providing low-intensity, low-cost interventions as a first time treatment, while stepping up care for those needing more intensive treatment. Specifically, a stepped care model for CAD that begins with a parent-focus intervention has great promise to deliver efficacious and cost-effective treatment without having to engage the child.
Read more
While stepped care approaches show promise in treating CAD with comparable efficacy to standard CBT, there remains a large research-to-practice gap. The stepped care model for CAD that begins with a parent-focused intervention has yet been explored, and very little is known about intervention mediators that explain mechanisms of change.
This research is being done to improve the reach and quality of services using a stepped care model, offering an affordable and practical solution to the widespread gap in youth mental health care.
Read the detailed description
Anxiety disorders in children and adolescents (CAD) are common and confer significant impairment in academic, peer, and family functioning. If left inadequately treated, CAD remains chronic and increases the risk of physical and mental health problems, unemployment, substance use disorders, and suicidality in adulthood. Family-based cognitive behavioral therapy (CBT) has demonstrated efficacy in the treatment of CAD. Yet, many children do not receive care due to barriers such as limited provider availability, high treatment cost, and familial constraints (e.g., time). Effective, personalized treatment approaches that are accessible, efficient, and cost-effective are needed. To combat these barriers, other treatment methods have been developed.
A stepped care model for CAD that begins with a parent-focus intervention has great promise to deliver efficacious and cost-effective treatment without having to engage the child. Stepped care is an alternative low-intensity parent focused delivery system that incorporates the best available evidence to treat CAD within a stepped care model, which utilizes task-shifting with parent involvement, honoring the role of parents in helping their children.
*The hypothesized treatment mechanisms include parent-focused targets (i.e., family accommodation, parental distress) and child-focused targets (i.e., emotional processing, inhibitory learning) and child-focused targets (i.e., emotional processing, inhibitory learning). The stepped care model would task-shift therapeutic components to parents using scalable multi-media-based content.
Although stepped care approaches show promise in treating CAD with comparable efficacy to standard CBT, there remains a large research-to-practice gap and very little is known about intervention mediators that explain mechanisms of change.
This research is being done to understand and improve the reach and quality of services using a stepped care model, offering an affordable and practical solution to the widespread gap in youth mental health care.
- Conditions
- Generalized Anxiety Disorder (GAD), Social Anxiety Disorder (SAD), Separation Anxiety Disorder, Specific Phobia, Obsessive Compulsive Disorder (OCD), Panic Disorder (With or Without Agoraphobia)
- Being tested
- Relaxation and Mentorship Training (RMT), Stepped Care Targeting Exposure and Parenting for Anxiety (STEP-A)
- Keywords
- Anxiety, Child, Adolescents, Obsessive compulsive disorder, stepped care, psychotherapy
- Medical subject headings
- Generalized Anxiety Disorder, Phobia, Social, Anxiety, Separation, Phobia, Specific, Obsessive-Compulsive Disorder, Panic Disorder, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relaxation and Mentorship Training (RMT)Behavioural
RMT is a multi-component relation-based protocol for children and adolescents experiencing anxiety. Initially designed as a control condition in multiple RCTs for CAD, the protocol integrates evidence-based relaxation strategies with non-anxiety specific elements, such as autobiographical writing
Stepped Care Targeting Exposure and Parenting for Anxiety (STEP-A)Behavioural
STEP-A is a two-step treatment with Step 1 an abbreviated version of SPACE, which has demonstrated comparable efficacy to standard SPACE for CAD and OCD. In Step 1, parents read Breaking Free of Child Anxiety and OCD and engage in therapeutic tasks with their child while meeting with the therapist for four, 45-minute sessions at weeks 2, 4, 6, and 8. STEP-A Step 1 responders proceed to a 10-week maintenance period to practice skills learned.
Step 2 consists of PCET, an empirically validated family-based CBT protocol designed to treat CAD more effectively and efficiently than traditional CBT by emphasizing exposures and increasing parental involvement to maximize generalization. Ten weekly sessions with the therapist. Sessions 1 and 2 include psychoeducation and development of exposure hierarchy, while sessions 3, onward, emphasize in-session exposure practice and identifying between-session exposure homework, with parents leading in-session exposures starting session 5, onward.
| Study group | Role | What they receive |
|---|---|---|
| Relaxation and Mentorship Training | Active comparator | Families randomized to Relaxation and Mentorship Training (RMT) will receive 14 sessions of relaxation training to match intervention dosage in STEP-A. RMT is a multi-component relation-based protocol for children and adolescents experiencing anxiety. Initially designed as a control condition in multiple RCTs for CAD, the protocol integrates evidence-based relaxation strategies with non-anxiety specific elements, such as autobiographical writing. Sessions 1-7 will occur weekly across seven weeks to align timing of sessions 1-4 in Step 1 of STEP-A. Aligning the timing of Sessions 1-4 allows us to test treatment mechanisms, ensures equipoise between arms for cost-effeteness analyses keeping treatment durations equivalent. To ensure children in both conditions receive a full 14-sessions of therapy the last 4 sessions of RMT are staggered to mimic the staggering of SPACE in step one. Receives: Behavioral: Relaxation and Mentorship Training (RMT) |
| Stepped Care Targeting Exposure and Parenting for Anxiety (STEP-A) | Experimental | STEP-A is a two-step treatment with Step 1 an abbreviated version of SPACE, which has demonstrated comparable efficacy to standard SPACE for CAD and OCD. In Step 1, parents read Breaking Free of Child Anxiety and OCD and engage in therapeutic tasks with their child while meeting with the therapist for four, 45-minute sessions at weeks 2, 4, 6, and 8. STEP-A Step 1 responders proceed to a 10-week maintenance period to practice skills learned.
Step 2 consists of PCET, an empirically validated family-based CBT protocol designed to treat CAD more effectively and efficiently than traditional CBT by emphasizing exposures and increasing parental involvement to maximize generalization. Ten weekly sessions with the therapist. Sessions 1 and 2 include psychoeducation and development of exposure hierarchy, while sessions 3, onward, emphasize in-session exposure practice and identifying between-session exposure homework, with parents leading in-session exposures starting session 5, onward. Receives: Behavioral: Stepped Care Targeting Exposure and Parenting for Anxiety (STEP-A) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pediatric Anxiety Rating Scale
The Pediatric Anxiety Rating Scale is a clinician-administered measures of pediatric anxiety symptom and symptom severity, that can be used across a broad range of anxiety-related disorders. The first part of the measure consists of a symptom checklist where responses are recorded from both the child and caregiver/parent to index the various types of anxiety the child experiences. The second part is a 7-item symptom severity scale where responses are recorded using a 0 ("no symptoms") to 5 ("extreme") Likert-type scale. Different scoring methods can be used, including a 5-item scoring (range = 0 - 25), that is preferred for clinical trial research, and is calculated using the sum of items 2, 3, 5, 6, and 7; this approach excludes items assessing overall number of anxiety symptoms and somatic symptoms. Higher scores are suggestive of more severe anxiety.
Measured: Baseline (before treatment or week 1), midway point (week 8), stepped care treatment (7 weeks), PCET during treatment (10 weeks), post (week 20), 1 month follow-up (week 24), caregiver interview (week 32)
The Clinical Global Impression-Severity
The Clinical Global Impression-Severity is a single-item rating of symptom severity that can be used across a broad range of mental health conditions. The measure asks the rater to assess the overall severity of the individual's illness with response options ranging from 1 ("normal; no illness") to 7 ("among the most extremely ill patients").
Measured: Baseline (before treatment or week 1), midway point (week 8), stepped care treatment (7 weeks), PCET during treatment (10 weeks), post (week 20), 1 month follow-up (week 24), caregiver interview (week 32)
The Clinical Global Impression-Improvement
The Clinical Global Impressions-Improvement Scale is a single-item assessment measure used to assess overall improvement in symptoms relative to baseline. Responses are recorded using a 1 ("very much worse) to 7 ("very much improved") scale, with the midpoint, 4, reflecting "no change" since baseline.
Measured: Baseline (before treatment or week 1), midway point (week 8), stepped care treatment (7 weeks), PCET during treatment (10 weeks), post (week 20), 1 month follow-up (week 24), caregiver interview (week 32)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2025
- Study start5 Jan 2026
- Primary completion31 Aug 2027 (estimated)
- Study completion30 Apr 2028 (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 Generalized Anxiety Disorder (GAD)Studies 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
- Sequential
- Model description
- Stepped-care treatment model compared to active control group
- Masking
- None (open label)
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Andrew Wiese
- Sponsor type
- University, hospital or other
- Collaborators
- Baylor College of Medicine
- Responsible party
- Sponsor-investigator, Andrew Wiese, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07228143
- Sponsor's protocol ID
- H-58155
- Acronym
- STAR
- Status last verified
- Feb 2026
- First submitted
- 12 Nov 2025
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participant data will not be available to others outside of the study protocol due to concerns o participant confidentiality and sensitivity surrounding mental health symptoms assessed.
Publications
Whiteside SPH, Sim LA, Morrow AS, Farah WH, Hilliker DR, Murad MH, Wang Z. A Meta-analysis to Guide the Enhancement of CBT for Childhood Anxiety: Exposure Over Anxiety Management. Clin Child Fam Psychol Rev. 2020 Mar;23(1):102-121. doi: 10.1007/s10567-019-00303-2.
PubMed 31628568Cervin M, Kendall PC, Piacentini JC, Gosch EA, Wood JJ, Schneider SC, Salloum A, Birmaher B, Guzick AG, Mataix-Cols D, Storch EA. Assessing reliable change, MCID, treatment response, and remission using the Pediatric Anxiety Rating Scale (PARS) in youth with anxiety disorders. J Anxiety Disord. 2025 Sep 11;115:103070. doi: 10.1016/j.janxdis.2025.103070. Online ahead of print.
PubMed 40946358Storch EA, Salloum A, King MA, Crawford EA, Andel R, McBride NM, Lewin AB. A RANDOMIZED CONTROLLED TRIAL IN COMMUNITY MENTAL HEALTH CENTERS OF COMPUTER-ASSISTED COGNITIVE BEHAVIORAL THERAPY VERSUS TREATMENT AS USUAL FOR CHILDREN WITH ANXIETY. Depress Anxiety. 2015 Nov;32(11):843-52. doi: 10.1002/da.22399. Epub 2015 Sep 14.
PubMed 26366886Whiteside SPH, Biggs BK, Geske JR, Gloe LM, Reneson-Feeder ST, Cunningham M, Dammann JE, Brennan E, Ong ML, Olsen MW, Hofschulte DR. Parent-coached exposure therapy versus cognitive behavior therapy for childhood anxiety disorders. J Anxiety Disord. 2024 Jun;104:102877. doi: 10.1016/j.janxdis.2024.102877. Epub 2024 May 18.
PubMed 38788593Storch EA, Guzick AG, Ayton DM, Palo AD, Kook M, Candelari AE, Maye CE, McNeel M, Trent ES, Garcia JL, Onyeka OC, Rast CE, Shimshoni Y, Lebowitz ER, Goodman WK. Randomized trial comparing standard versus light intensity parent training for anxious youth. Behav Res Ther. 2024 Feb;173:104451. doi: 10.1016/j.brat.2023.104451. Epub 2023 Dec 17.
PubMed 38154287
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stepped Care Cognitive Behavioral Therapy for Children and Adolescents With Anxiety
- ClinicalTrials.gov ID
- NCT07228143
- Acronym / sponsor ID
- STAR / H-58155
- Conditions
- Generalized Anxiety Disorder (GAD), Social Anxiety Disorder (SAD), Separation Anxiety Disorder, Specific Phobia, Obsessive Compulsive Disorder (OCD), Panic Disorder (With or Without Agoraphobia)
- Keywords
- Anxiety, Child, Adolescents, Obsessive compulsive disorder, stepped care, psychotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Andrew WieseUniversity, hospital or other
- Collaborators
- Baylor College of Medicine
- Study start
- 5 Jan 2026 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 14 Nov 2025 (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.
Childhood anxiety disorders (CAD) are common and impairing. Family based cognitive behavioral therapy (CBT) is efficacious in treating CAD. Yet, many children do not receive care due to barriers such as limited provider availably, high treatment costs, and constrained family resources (e.g., time). To combat these barriers, other treatment methods have been developed.
The stepped care treatment models maximize resources by providing low-intensity, low-cost interventions as a first time treatment, while stepping up care for those needing more intensive treatment. Specifically, a stepped care model for CAD that begins with a parent-focus intervention has great promise to deliver efficacious and cost-effective treatment without having to engage the child.
While stepped care approaches show promise in treating CAD with comparable efficacy to standard CBT, there remains a large research-to-practice gap. The stepped care model for CAD that begins with a parent-focused intervention has yet been explored, and very little is known about intervention mediators that explain mechanisms of change.
This research is being done to improve the reach and quality of services using a stepped care model, offering an affordable and practical solution to the widespread gap in youth mental health care.
Detailed description
Anxiety disorders in children and adolescents (CAD) are common and confer significant impairment in academic, peer, and family functioning. If left inadequately treated, CAD remains chronic and increases the risk of physical and mental health problems, unemployment, substance use disorders, and suicidality in adulthood. Family-based cognitive behavioral therapy (CBT) has demonstrated efficacy in the treatment of CAD. Yet, many children do not receive care due to barriers such as limited provider availability, high treatment cost, and familial constraints (e.g., time). Effective, personalized treatment approaches that are accessible, efficient, and cost-effective are needed. To combat these barriers, other treatment methods have been developed.
A stepped care model for CAD that begins with a parent-focus intervention has great promise to deliver efficacious and cost-effective treatment without having to engage the child. Stepped care is an alternative low-intensity parent focused delivery system that incorporates the best available evidence to treat CAD within a stepped care model, which utilizes task-shifting with parent involvement, honoring the role of parents in helping their children.
*The hypothesized treatment mechanisms include parent-focused targets (i.e., family accommodation, parental distress) and child-focused targets (i.e., emotional processing, inhibitory learning) and child-focused targets (i.e., emotional processing, inhibitory learning). The stepped care model would task-shift therapeutic components to parents using scalable multi-media-based content.
Although stepped care approaches show promise in treating CAD with comparable efficacy to standard CBT, there remains a large research-to-practice gap and very little is known about intervention mediators that explain mechanisms of change.
This research is being done to understand and improve the reach and quality of services using a stepped care model, offering an affordable and practical solution to the widespread gap in youth mental health care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Stepped-care treatment model compared to active control group
| Arm | Type | Receives |
|---|---|---|
| Relaxation and Mentorship Training | Active comparator | Behavioral: Relaxation and Mentorship Training (RMT)Families randomized to Relaxation and Mentorship Training (RMT) will receive 14 sessions of relaxation training to match intervention dosage in STEP-A. RMT is a multi-component relation-based protocol for children and adolescents experiencing anxiety. Initially designed as a control condition in multiple RCTs for CAD, the protocol integrates evidence-based relaxation strategies with non-anxiety specific elements, such as autobiographical writing. Sessions 1-7 will occur weekly across seven weeks to align timing of sessions 1-4 in Step 1 of STEP-A. Aligning the timing of Sessions 1-4 allows us to test treatment mechanisms, ensures equipoise between arms for cost-effeteness analyses keeping treatment durations equivalent. To ensure children in both conditions receive a full 14-sessions of therapy the last 4 sessions of RMT are staggered to mimic the staggering of SPACE in step one. |
| Stepped Care Targeting Exposure and Parenting for Anxiety (STEP-A) | Experimental | Behavioral: Stepped Care Targeting Exposure and Parenting for Anxiety (STEP-A)STEP-A is a two-step treatment with Step 1 an abbreviated version of SPACE, which has demonstrated comparable efficacy to standard SPACE for CAD and OCD. In Step 1, parents read Breaking Free of Child Anxiety and OCD and engage in therapeutic tasks with their child while meeting with the therapist for four, 45-minute sessions at weeks 2, 4, 6, and 8. STEP-A Step 1 responders proceed to a 10-week maintenance period to practice skills learned. Step 2 consists of PCET, an empirically validated family-based CBT protocol designed to treat CAD more effectively and efficiently than traditional CBT by emphasizing exposures and increasing parental involvement to maximize generalization. Ten weekly sessions with the therapist. Sessions 1 and 2 include psychoeducation and development of exposure hierarchy, while sessions 3, onward, emphasize in-session exposure practice and identifying between-session exposure homework, with parents leading in-session exposures starting session 5, onward. |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- A primary diagnosis of OCD or an anxiety disorder including separation anxiety disorder, social phobia, generalized anxiety disorder, specific phobia, agoraphobia, panic disorder, as determine by an IE using the DIAMOND-KID diagnostic interview.
- Score of ≥ 14 on the PARS (items 2-7) which corresponds to clinically significant anxiety.
- The child is 7-17 years old.
- Residence in Texas and located in the state of Texas during treatment sessions.
Key exclusion criteria (4 listed)
- -Psychosis, cognitive disability, any condition that would limit the caregiver's ability to follow instructions.
- Parent substance use disorder within the past 3 months, which could impact their ability to implement step 1
- Child or parent is suicidal. A delayed entry once the parent or child is stabilized (>6 months post suicidality) and no longer has suicidal ideation will be allowed if appropriate.
- New pharmacological interventions or treatment changes: Initiation of an antidepressant within 12 weeks before study enrollment or 6 weeks for an antipsychotic, benzodiazepine, or attention deficit hyperactivity disorder (ADHD) medication before enrollment, or any change in established psychotropic medication (e.g., antidepressants, anxiolytics) within 6 weeks before study enrollment (4 weeks for antipsychotic, anti-anxiety, benzodiazepine, or ADHD medication changes). Medications will remain stable during treatment.
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 |
|---|---|---|
| Relaxation and Mentorship Training (RMT)RMT is a multi-component relation-based protocol for children and adolescents experiencing anxiety. Initially designed as a control condition in multiple RCTs for CAD, the protocol integrates evidence-based relaxation strategies with non-anxiety specific elements, such as autobiographical writing | Behavioural | Relaxation and Mentorship Training |
| Stepped Care Targeting Exposure and Parenting for Anxiety (STEP-A)STEP-A is a two-step treatment with Step 1 an abbreviated version of SPACE, which has demonstrated comparable efficacy to standard SPACE for CAD and OCD. In Step 1, parents read Breaking Free of Child Anxiety and OCD and engage in therapeutic tasks with their child while meeting with the therapist for four, 45-minute sessions at weeks 2, 4, 6, and 8. STEP-A Step 1 responders proceed to a 10-week maintenance period to practice skills learned. Step 2 consists of PCET, an empirically validated family-based CBT protocol designed to treat CAD more effectively and efficiently than traditional CBT by emphasizing exposures and increasing parental involvement to maximize generalization. Ten weekly sessions with the therapist. Sessions 1 and 2 include psychoeducation and development of exposure hierarchy, while sessions 3, onward, emphasize in-session exposure practice and identifying between-session exposure homework, with parents leading in-session exposures starting session 5, onward. | Behavioural | Stepped Care Targeting Exposure and Parenting for Anxiety (STEP-A) |
Primary outcome
Pediatric Anxiety Rating Scale
Time frame: Baseline (before treatment or week 1), midway point (week 8), stepped care treatment (7 weeks), PCET during treatment (10 weeks), post (week 20), 1 month follow-up (week 24), caregiver interview (week 32)
The Pediatric Anxiety Rating Scale is a clinician-administered measures of pediatric anxiety symptom and symptom severity, that can be used across a broad range of anxiety-related disorders. The first part of the measure consists of a symptom checklist where responses are recorded from both the child and caregiver/parent to index the various types of anxiety the child experiences. The second part is a 7-item symptom severity scale where responses are recorded using a 0 ("no symptoms") to 5 ("extreme") Likert-type scale. Different scoring methods can be used, including a 5-item scoring (range = 0 - 25), that is preferred for clinical trial research, and is calculated using the sum of items 2, 3, 5, 6, and 7; this approach excludes items assessing overall number of anxiety symptoms and somatic symptoms. Higher scores are suggestive of more severe anxiety.
The Clinical Global Impression-Severity
Time frame: Baseline (before treatment or week 1), midway point (week 8), stepped care treatment (7 weeks), PCET during treatment (10 weeks), post (week 20), 1 month follow-up (week 24), caregiver interview (week 32)
The Clinical Global Impression-Severity is a single-item rating of symptom severity that can be used across a broad range of mental health conditions. The measure asks the rater to assess the overall severity of the individual's illness with response options ranging from 1 ("normal; no illness") to 7 ("among the most extremely ill patients").
The Clinical Global Impression-Improvement
Time frame: Baseline (before treatment or week 1), midway point (week 8), stepped care treatment (7 weeks), PCET during treatment (10 weeks), post (week 20), 1 month follow-up (week 24), caregiver interview (week 32)
The Clinical Global Impressions-Improvement Scale is a single-item assessment measure used to assess overall improvement in symptoms relative to baseline. Responses are recorded using a 1 ("very much worse) to 7 ("very much improved") scale, with the midpoint, 4, reflecting "no change" since baseline.
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 2 Mar 2026.
- Background: PubMed 31628568Whiteside SPH, Sim LA, Morrow AS, Farah WH, Hilliker DR, Murad MH, Wang Z. A Meta-analysis to Guide the Enhancement of CBT for Childhood Anxiety: Exposure Over Anxiety Management. Clin Child Fam Psychol Rev. 2020 Mar;23(1):102-121. doi: 10.1007/s10567-019-00303-2.
- Background: PubMed 40946358Cervin M, Kendall PC, Piacentini JC, Gosch EA, Wood JJ, Schneider SC, Salloum A, Birmaher B, Guzick AG, Mataix-Cols D, Storch EA. Assessing reliable change, MCID, treatment response, and remission using the Pediatric Anxiety Rating Scale (PARS) in youth with anxiety disorders. J Anxiety Disord. 2025 Sep 11;115:103070. doi: 10.1016/j.janxdis.2025.103070. Online ahead of print.
- Background: PubMed 26366886Storch EA, Salloum A, King MA, Crawford EA, Andel R, McBride NM, Lewin AB. A RANDOMIZED CONTROLLED TRIAL IN COMMUNITY MENTAL HEALTH CENTERS OF COMPUTER-ASSISTED COGNITIVE BEHAVIORAL THERAPY VERSUS TREATMENT AS USUAL FOR CHILDREN WITH ANXIETY. Depress Anxiety. 2015 Nov;32(11):843-52. doi: 10.1002/da.22399. Epub 2015 Sep 14.
- Background: PubMed 38788593Whiteside SPH, Biggs BK, Geske JR, Gloe LM, Reneson-Feeder ST, Cunningham M, Dammann JE, Brennan E, Ong ML, Olsen MW, Hofschulte DR. Parent-coached exposure therapy versus cognitive behavior therapy for childhood anxiety disorders. J Anxiety Disord. 2024 Jun;104:102877. doi: 10.1016/j.janxdis.2024.102877. Epub 2024 May 18.
- Background: PubMed 38154287Storch EA, Guzick AG, Ayton DM, Palo AD, Kook M, Candelari AE, Maye CE, McNeel M, Trent ES, Garcia JL, Onyeka OC, Rast CE, Shimshoni Y, Lebowitz ER, Goodman WK. Randomized trial comparing standard versus light intensity parent training for anxious youth. Behav Res Ther. 2024 Feb;173:104451. doi: 10.1016/j.brat.2023.104451. Epub 2023 Dec 17.
- Individual participant dataSharing planned: No. Participant data will not be available to others outside of the study protocol due to concerns o participant confidentiality and sensitivity surrounding mental health symptoms assessed.
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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.
Jazzmine Ward, BS contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Relaxation and Mentorship Training (RMT) and Stepped Care Targeting Exposure and Parenting for Anxiety (STEP-A) in people with Generalized Anxiety Disorder (GAD) and Social Anxiety Disorder (SAD), run by Andrew Wiese 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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 2 Mar 2026. 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?
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?
Contact Andrew D Wiese, PhD (713-798-3080, andrew.wiese@bcm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pediatric Anxiety Rating Scale (time frame: Baseline (before treatment or week 1), midway point (week 8), stepped care treatment (7 weeks), PCET during treatment (10 weeks), post (week 20), 1 month follow-up (week 24), caregiver interview (week 32)). The study lists 3 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 NCT07228143, 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 2 Mar 2026.