Clinical trial NCT03255122: Technology and Early Anxiety Treatment
Official title: Harnessing Technology to Extend the Reach of Supported Care for Families Affected by Early Child Social Anxiety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Disorders
Lead sponsor: Florida International University
Sponsor class: OTHER
Collaborators: name: Andrew Kukes Foundation for Social Anxiety
First posted: 2017-08-21
Enrollment: 40
Sex: ALL
Minimum age (years): 3
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Families are randomly designed to receive either immediate treatment (I-CALM) or waitlist and then I-CALM
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinical Global Impressions Scales - Severity and Improvement (CGI-S/I)
timeFrame: 5 minutes
Secondary outcomes:
measure: Children's Global Assessment Scale
timeFrame: 5 minutes
measure: Child Anxiety Impact Scale
timeFrame: 5 minutes
measure: Family Burden Assessment Scale
timeFrame: 5 minutes
measure: Family Accommodation Checklist and Interference Scale
timeFrame: 10 minutes
measure: Family Accommodation Scale- Anxiety
timeFrame: 10 minutes
measure: Working Alliance Inventory
timeFrame: 10 minutes
measure: Client Satisfaction Questionnaire
timeFrame: 3 minutes
measure: Child Behavior Checklist
timeFrame: 25 minutes
measure: Anxiety Disorders Interview Schedule for Children (ADIS-C/P)
timeFrame: 2 hours
measure: Spence Children's Anxiety Scale
timeFrame: 15 minutes
Other outcomes:
Locations:
city: Miami
country: United States
facility: Florida International University
state: Florida
Study officials:
affiliation: Florida International University
name: Jonathan S Comer, PhD
role: PRINCIPAL_INVESTIGATOR
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