This nonrandomized pilot study is investigating the efficacy of a modularized treatment for
anxiety in children ages 3-7 years old. Eligibility is determined at a baseline assessment,
followed by a second baseline assessment one month later. The treatment protocol,
Parent-training Intervention for Preschoolers with Anxiety (PIPA), is flexible and allows
for individualized treatments based on a treatment algorithm, ensuring that sessions address
the most pressing clinical needs of each child. Treatment consists of weekly 60-minute
sessions delivered over the course of 12 weeks. Symptom change is tracked weekly during
brief phone assessments and a post-treatment assessment will occur following the final
treatment session, approximately 12 weeks after starting treatment. Finally, all
participants will complete two follow-up assessments, occurring 1-month and 6-months after
the final treatment session.
Early childhood mental illness is a growing public health concern, and can persist into
adolescence and adulthood if left untreated. Anxiety disorders are among the most common
psychiatric illnesses in preschool aged youth and place youth at significantly higher risk
for anxiety, depression, substance abuse, conduct problems, and diminished
academic/occupational and social/relational functioning later in life. Accordingly, there is
increasing emphasis on early identification and intervention, before symptoms become
entrenched to mitigate a trajectory towards longstanding impairment.
Unfortunately, empirically supported treatments for preschoolers with anxiety are limited.
The few studies to date have tended to focus on relatively homogeneous samples whose
symptoms resemble those in adults (e.g., worries and fears). Anxiety can present in similar
ways to adult anxiety, however can also present more broadly in young children. Young
children with anxiety may also present with extreme rigidity, sensory hypersensitivity,
'meltdowns'/emotional dysregulation/temper tantrums, ritualistic/routine oriented behavior,
and oppositional behavior in some context. By focusing narrowly, treatments have not been
adapted for the full range of anxiety presentations in early childhood.
Therefore, the proposed study evaluates a modular, parent-driven psychotherapy developed for
preschool aged youth (3-7 years) with diagnostic levels of anxiety, as well as anxiety
symptoms dimensionally. The treatment program, Parent-training Intervention for Preschoolers
with Anxiety (PIPA), is based on empirically supported behavioral and parent-training
principles as well as the investigators' recently published pilot study of preschoolers with
obsessive compulsive disorder. Sixty youth will be treated during the study. PIPA focuses on
exposure and response prevention therapy (E/RP) in the context of behavioral parent
training, each of which have efficacy in youth with anxiety, including high functioning
autism spectrum disorders (ASD). Certain parenting responses (e.g., overprotection, critical
responding, accommodation of anxiety symptoms and avoidance) have been implicated in the
etiology and maintenance of pediatric anxiety disorders and, in addition to E/RP, this
intervention will target behavioral parent training and unhelpful parenting practices to
support long-term outcomes.
In addition, this study will investigate one surrogate biomarker of anxiety in young
children, fear conditioning (or more specifically, resistance to extinction). Behavioral
treatment of anxiety, including the proposed PIPA intervention, relies on principles of
extinction. Children and adults with anxiety disorders have been shown to have poorer fear
extinction; however, there are few studies in young children examining this phenomenon. The
potential to understand fear extinction in young children has implications for improving
treatment efficacy and altering the negative trajectory of youth with anxiety disorders.
Eligibility will be determined at a baseline assessment. A second baseline assessment will
occur one month later for those that qualify. This assessment will be used to control for
symptom change due to the natural passage of time. Treatment will be delivered over 12 weeks
and will include weekly 60-minute sessions. A brief phone call with an assessor each week
will be used to track symptom change during treatment, and a post-treatment assessment will
be conducted following the final treatment session, approximately 12 weeks later. Follow-up
assessments will occur 1-month and 6-months following the final treatment session.
- Children aged 3 to 7 years
- Anxiety-based concerns rated as a top problem on the Top Problems Assessment at
- Report or evidence of severe intellectual disability or level 3 autism spectrum
disorder (ASD) without accompanying intellectual/language impairment (mild ASD is not
- Presence of clinical features requiring a higher level of care (inpatient or partial
- Unwillingness of parents to accompany their children for multiple study visits;
- Presence of a significant and/or unstable medical illness that might lead to
hospitalization during the study.
- Initiation of an antidepressant within the 12 weeks preceding study enrollment,
antipsychotic within 8 weeks prior to study enrollment, changes in established
psychotropic medications within 8 weeks before study enrollment, or any change in
alternative medications that might have behavioral effects within 6 weeks prior to
study baseline assessment. Youth may remain stable on medications during the study.
- Ongoing reports of abuse/neglect or trauma reported as a primary concern.
- Extreme aggression/risk behaviors (e.g., harming animals, fire starting, violence)
suggestive of conduct disorder trajectory.