Stepped Care Treatment for Anxiety in Children and Adolescents

This study is exploring two different approaches to help children and adolescents (ages 7-17) with anxiety disorders like Generalized Anxiety Disorder (GAD), Social Anxiety Disorder (SAD), Separation Anxiety Disorder, Specific Phobia, and Obsessive Compulsive Disorder (OCD). The first approach is called Relaxation and Mentorship Training (RMT), which uses relaxation techniques and writing exercises. The second is Stepped Care Targeting Exposure and Parenting for Anxiety (STEP-A), a two-step treatment where parents learn strategies to help their child. Researchers will measure how much anxiety improves using scales like the Pediatric Anxiety Rating Scale (PARS) and Clinical Global Impression scales over several months to see which treatment is most effective. This study aims to find accessible and cost-effective ways to treat childhood anxiety.

Study design
This is an interventional study planning to enroll 106 participants. It is not specified if participants will be randomly assigned to a treatment group or if the study is blinded.
What's involved
Participants will be evaluated at the beginning, midway through treatment (week 8), during treatment (weeks 7 and 10), after treatment (week 20), and at 1-month (week 24) and 3-month (week 32) follow-ups.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 1 month after treatment (week 24) and then again at 3 months after treatment (week 32).

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NCT07228143

Stepped Care Treatment for Anxiety Resilience

Recruiting
NAAges 7–17InterventionalTreatment
Andrew Wiese
~106 participants
Updated 2026-03-02 on ClinicalTrials.gov
What's tested:Relaxation and Mentorship Training (RMT)Stepped Care Targeting Exposure and Parenting for Anxiety (STEP-A)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Pediatric Anxiety Rating Scale
Measured over 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)
+2 more outcomes measured
Generalized Anxiety Disorder (GAD)
Social Anxiety Disorder (SAD)
Separation Anxiety Disorder
Specific Phobia
Obsessive Compulsive Disorder (OCD)
Panic Disorder (With or Without Agoraphobia)
1 sites across 1 states
Texas1

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Eligibility criteria

Inclusion

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.

Exclusion

-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.
  • Pediatric Anxiety Rating ScaleBaseline (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-SeverityBaseline (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-ImprovementBaseline (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.