Technology and Early Anxiety Treatment
Condition: Anxiety Disorders
MeSH terms: Anxiety Disorders
Study type: Interventional

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.
    

Detailed 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.
    

Intervention name(s): I-CALM; Delayed I-CALM
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Families receiving I-CALM will immediately receive a videoconferencing-based, 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; Puliafico, Comer, & Albano, 2013) 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. Parents are taught and guided in how to coach their young anxious child to engage in brave, approach behavior.; Families receiving Delayed I-CALM will participate in a waitlist period, and then will complete the I-CALM treatment program.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Families are randomly designed to receive either immediate treatment (I-CALM) or waitlist and then I-CALM
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment