Technology and Early Anxiety Treatment

Anxiety Disorders Clinical Trial

Official title: Harnessing Technology to Extend the Reach of Supported Care for Families Affected by Early Child Social Anxiety

Status Completed

Clinical Trial Summary

The goal of the study is to evaluate the efficacy of an Internet-delivered format of an evidence-based CBT treatment for early social anxiety disorder (Coaching Approach behavior and Leading by Modeling, or the CALM Program) in which therapists and families meet in real-time via videoconferencing and parent-child interactions are broadcast from the family's home via a webcam while therapists provide bug-in-the-ear coaching from a remote site. In a randomized controlled trial (RCT), the proposed work will evaluate 40 youth with social anxiety disorder (ages 3-8); 20 will receive the CALM Program over the Internet (I-CALM) and 20 will be assigned to a waitlist control and will complete a course of I-CALM after the waitlist period. Outcomes will be assessed via structured diagnostic interviews and parent-report questionnaires.

Clinical Trial Description

The goal of the study is to evaluate the efficacy of an Internet-delivered format of an evidence-based CBT treatment for early child social anxiety disorder (Coaching Approach behavior and Leading by Modeling, or the CALM Program) in which therapists and families meet in real-time via videoconferencing and parent-child interactions are broadcast from the family's home via a webcam while therapists provide bug-in-the-ear coaching from a remote site. In a randomized controlled trial (RCT), the proposed work will evaluate 40 youth with social anxiety disorder (ages 3-8); 20 will receive the CALM Program over the Internet (I-CALM) and 20 will be assigned to a waitlist control, followed by I-CALM treatment.

SPECIFIC AIMS:

• Aim 1: To evaluate I-CALM efficacy for reducing early child social anxiety symptoms and related impairments and for improving child and parent quality of life.

• Aim 2: To examine the extent to which I-CALM helps families overcome traditional barriers to effective care, including geographic barriers and regional professional workforce shortages in social anxiety expert care.

• Aim 3: To evaluate the feasibility, acceptability, and satisfaction of I-CALM from the perspective of treated\ families, and lay the foundation for a large Florida statewide implementation of I-CALM for early social anxiety.

RATIONALE: Despite progress in supported programs for child social anxiety disorder, gaps persist between treatment in specialty clinics and services broadly available in the community. Although considerable advances show social anxiety is treatable when appropriate CBT is available, barriers interfere with the broad provision of quality care. Few sufferers receive services, and those who do receive services do not necessarily receive evidence-based care. Many U.S. counties have no psychologist, psychiatrist, or social worker, let alone professionals trained in supported social anxiety treatments. When effective programs are available, transportation issues constrain access, with large proportions of patients reporting that services are too far away or they have no way to get to a clinic. Expert providers cluster around metropolitan regions and major academic hubs, leaving considerable numbers of youth without access to supported service options. Youth from low-income or remote and rural communities are particularly unlikely to receive appropriate care. High rates of stigma-related beliefs further constrain service utilization, with many reporting negative attitudes about visiting a mental health clinic.

An Internet-delivered, real-time intervention for the remote treatment of early child social anxiety disorder has the potential to meaningfully extend the reach of effective social anxiety treatment for underserved youth and can serve as the critical foundation upon which to build a larger-scale statewide implementation of early social anxiety treatment. Moreover, treating youth in their homes can overcome stigma-related concerns that interfere with families attending services at a psychiatric clinic, and treatment gains may be more generalizable and ecologically valid as services are provided to youth in their natural settings.

SERVICES: The CALM Program (Coaching Approach behavior and Leading by Modeling) was developed as a developmentally compatible intervention to treat anxiety disorders in children below age

8. The CALM Program is an adaptation of Parent-Child Interaction Therapy (PCIT), which was initially developed to treat early behavior problems, and incorporates a family-based approach to early child anxiety. Whereas effective treatment for older socially anxious youth requires a set of cognitive abilities that younger children typically do not fully possess, it has been demonstrated that adaptations of PCIT—which do not target children directly, but rather work to reshape the primary contexts of child development in order to treat child anxiety—can offer more developmentally compatible approaches for intervening with early social anxiety. The CALM Program is a parent-focused treatment that educates families about social anxiety and teaches parents skills to effectively reinforce their children's brave social behavior and coaches the use of these skills during in-session parent-child interactions. The treatment emphasizes live, bug-in-the-ear coaching of parents during in vivo exposure sessions. Child symptoms are targeted by reshaping interaction patterns associated with the maintenance of child anxiety and by reducing parental accommodation of child bids to avoid social situations.

Traditionally, the CALM therapist is situated behind a one-way mirror and unobtrusively provides real-time feedback to parents through a parent-worn earpiece. It has been suggested that PCIT-based approaches are particularly amenable to a web format given that by design the therapist conducts live observation and feedback from another room via a parent-worn bug-in-the-ear device. That is, even in standard clinic-based CALM, the therapist is predominantly separated from the family in order to foster naturalistic family interactions and child behavior. Despite progress in the development of the CALM Program for social anxiety, and progress in the field of behavioral telehealth, research has yet to evaluate the efficacy of an Internet-delivered format of the CALM Program (I-PCIT) for extending the accessibility of treatment. I-CALM families will receive treatment using secure and encrypted videoconferencing software, and parents will receive live coaching via a Bluetooth earpiece. Independent evaluators will conduct diagnostic interviews, collect parent-report forms, and conduct structured observations at baseline, post-treatment, and 6-months follow-up.

OUTCOMES: Independent evaluators (IEs) masked to participant condition assignment will conduct diagnostic interviews, collect parent-report forms, and conduct structured observations at baseline, post-treatment, and 6-month follow-up. ;

Related Conditions & MeSH terms

• Anxiety Disorders

• NCT number: NCT03255122
• Study type: Interventional
• Source: Florida International University
• Status: Completed
• Phase: N/A
• Start date: November 3, 2016
• Completion date: April 22, 2020