Technology and Early Anxiety Treatment

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.

Inclusion Criteria:

- Children 3-8 years old, and at least one primary caregiver

- Child has diagnosis of social anxiety disorder (as assessed in pre-treatment
assessment).

- Child and parent both speak either English or Spanish fluently

- Family's home is equipped with computing device and high-speed internet

Exclusion Criteria:

- Child has emotional/behavioral problem more impairing than difficulties captured by an
anxiety disorder diagnosis.

- Child receiving medication or other psychotherapy to manage emotional difficulties

- History of severe physical or mental impairments (e.g., intellectual disability,
deafness, blindness, pervasive developmental disorder) in child or participating
caregiver(s)

- Child is a ward of the state