Stepped Care Treatment for Anxiety Resilience (STAR)

Andrew Wiese

Status: Not yet enrolling

Conditions: Panic Disorder (With or Without Agoraphobia); Social Anxiety Disorder (SAD); Specific Phobia; Obsessive Compulsive Disorder (OCD); Generalized Anxiety Disorder (GAD); Separation Anxiety Disorder

Treatments: Behavioral: Stepped Care Targeting Exposure and Parenting for Anxiety (STEP-A); Behavioral: Relaxation and Mentorship Training (RMT)

Study type: Interventional

Funder types: Other

Identifiers

NCT07228143

H-58155

Details and patient eligibility

About

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.

Full 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.

Enrollment: 106 estimated patients

Sex: All

Ages: 7 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• -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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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106 participants in 2 patient groups

Relaxation and Mentorship Training

Active Comparator group

Description:

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.

Treatment:

Behavioral: Relaxation and Mentorship Training (RMT)

Stepped Care Targeting Exposure and Parenting for Anxiety (STEP-A)

Experimental group

Description:

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.

Treatment:

Behavioral: Stepped Care Targeting Exposure and Parenting for Anxiety (STEP-A)