Kids FACE FEARS Comparative Effectiveness Research
Condition: Child Anxiety; Anxiety Disorder of Adolescence
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      The Kids FACE FEARS (Kids Face-to-face And Computer-Enhanced Formats Effectiveness study for
      Anxiety and Related Symptoms) is a large-scale, streamlined, pragmatic Randomized Controlled
      Trial (RCT) evaluating face-to-face (therapist led office based or telehealth) vs.
      self-administered online cognitive-behavioral therapy (CBT) for the treatment of child and
      adolescent anxiety. Families will be recruited from pediatric health centers serving
      primarily racial/ethnic minority youth in urban, suburban, and semi-rural regions.
      Patient-centered outcomes will be evaluated across a one-year follow-up period; parents,
      patients, providers, and other key stakeholders will be actively engaged throughout all
      aspects of the research.
    

Detailed description: 
      Anxiety disorders are among the most common and impairing psychiatric disorders to affect
      children and adolescents. Cognitive Behavioral Therapy (CBT) is an effective psychological
      treatment for youth anxiety, with roughly 60-80% of youth showing considerable clinical
      response and global improvements in functioning. Regrettably, despite the existence of
      well-supported treatments, most youth with anxiety disorders do not receive any form of
      treatment, especially in resource poor settings. The pediatric health care setting offers an
      optimal public health venue for youth anxiety management, yet there is a critical lack of
      behavioral health specialty care providers who are trained in providing mental health
      treatment, and a lack of information on the optimal methods of treating anxiety in pediatric
      settings. Two evidence-based strategies for delivering CBT for youth with mild to moderate
      anxiety in pediatric settings are (1) face-to-face CBT delivered by therapists within
      pediatric health care in an office-based setting or via telehealth and (2) online delivery of
      CBT skills to youth and families. Importantly, however, there are no data on the relative
      effectiveness of these two treatment formats in real-world settings, and no information on
      which patient subgroups benefit most from which formats in patients in real-world practice.

      The study design entails a large-scale, streamlined, pragmatic, Randomized Controlled Trial
      (RCT), in which eligible anxious youth presenting to pediatric primary care settings will be
      randomly assigned to face-to-face versus online Cool Kids suite of CBT intervention for youth
      anxiety and monitored for up to one year post-intervention. Outcomes for each participant
      will be monitored across four assessment points, corresponding to baseline, mid-treatment,
      post-treatment, and 1 year post-baseline. Long-term outcomes associated with face-to-face
      versus online CBT will be evaluated over a 1-year period post-intervention. We will use the
      well-established Cool Kids suite of face-to-face and online anxiety CBT protocols within
      pediatric primary care networks serving primarily racial-ethnic minority children in both
      urban and rural settings across four regions of the US: the Northeast, the Mid-Atlantic, the
      Southeast, and the Pacific Northwest. Therapists embedded within pediatric primary care
      settings and mental health clinics co-located with primary care will provide all services.
      All participants will be identified and referred for enrollment from pediatric health
      settings.

      This study addresses three critical yet unanswered questions related to improving the
      delivery of treatment and outcomes for anxiety in pediatric primary care. Answering the
      following question offers the potential to meaningfully improve the quality of the evidence
      available to help children, families, and organizational stakeholders make informed decisions
      regarding clinical practice and implementation strategies for the treatment of childhood
      anxiety:

        1. What is the relative effectiveness of implementing therapist-led (face-to-face or
           telehealth) versus self-administered online formats of CBT to treat youth anxiety in
           pediatric health care?

        2. How do factors such as clinical severity, treatment preference, socioeconomic status,
           computer literacy, distance to clinic, organizational readiness, or medical home status
           moderate outcomes across treatment formats? Which patient subgroups might benefit most
           from which formats?

        3. What are the barriers and facilitators to delivering this care in pediatric health care
           settings and for the diverse patient populations served?
    

Intervention name(s): Therapist-led Face-to-Face Cognitive-Behavioral Therapy; Digital Cognitive-Behavioral Therapy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants receiving face-to-face cognitive-behavioral therapy will participate in therapist-led, office-based or telehealth CBT treatment for up to 16 weeks. Sessions focus on psychoeducation about anxiety, thought challenging and cognitive restructuring, somatic management skills training, youth exposure to feared stimuli, family patterns associated with the maintenance of youth anxiety, and contingent reinforcement.; Participants receiving digital cognitive-behavioral therapy will complete an online, largely self-administered CBT program for up to 16 weeks with 8 modules and adjunctive therapist phone support. Treatment modules focus on psychoeducation about anxiety, thought challenging and cognitive restructuring, somatic management skills training, youth exposure to feared stimuli, family patterns associated with the maintenance of youth anxiety, and contingent reinforcement.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cognitive Behavioral Therapy (CBT); Face to face CBT; Online CBT; Telehealth; Anxiety; Child