Clinical trial NCT04825756: Evaluating the Impact of Reining in Anxiety
Official title: Evaluating the Impact of Reining in Anxiety on Childhood Anxiety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Anxiety Disorder
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 78
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this pilot study is to evaluate the impact of Reining in Anxiety for children with anxiety and their caregivers. A total of up to 80 child/caregiver dyads will be enrolled in the study, anticipating that 40 dyads will complete the 10 week intervention. The intervention will be delivered at Fieldstone Farm Therapeutic Riding Center, which is one of the largest therapeutic riding centers in the US.

Detailed description: Reining in Anxiety is a manualized equine assisted therapy (EAT) for childhood anxiety. The manual and associated materials are being tested in this pilot study, and, if found to be successful, will be available for public consumption. This EAT, which is delivered in a group setting, combines therapeutic horseback riding with cognitive behavioral strategies for anxiety. The group meets weekly over the course of ten weeks, with each session lasting 45 minutes. Each session is delivered in a group format with up to four children between 6 and 17 years of age.

Eligibility criteria: Inclusion Criteria:

* Caregiver/child dyads where the children are between six and 17 years of age and their caregivers will be enrolled in the study.
* Children must have a score of 3 or higher as measured by the GAD-2,
* Children must have a minimum level of functioning as measured by the CGAS of 41 or higher.

Exclusion Criteria:

* An inability to provide informed consent

Primary outcomes:
measure: Change in levels of Anxiety
timeFrame: Before Session 1 (baseline) , After Session 10 ( after 6 months)
measure: Change in the Psychological functioning
timeFrame: Before Session 1 (baseline) , After Session 10 ( after 6 months)
Secondary outcomes:
measure: Change in children's emotional regulation
timeFrame: Before Session 1 (baseline) , After Session 10 ( after 6 months)
measure: Change in parents' perception of children's emotional regulation
timeFrame: Before Session 1 (baseline) , After Session 10 ( after 6 months)
measure: Change in emotional self efficacy
timeFrame: Before Session 1 (baseline) , After Session 10 ( after 6 months)
measure: Change in the level of knowledge of anxiety
timeFrame: Before Session 1 (baseline) , After Session 10 ( after 6 months)
measure: Traumatic events of children
timeFrame: Before Session 1 (baseline)
measure: Perception of child's feelings to the horse
timeFrame: After sessions 1 (baseline), 4 (2 months), 7 (4 months), and 10 (after 6 months)
measure: Perception of caregivers satisfaction
timeFrame: After Session 10 (after 6 months)
measure: Perception of instructor's satisfaction
timeFrame: After Session 10 (after 6 months)
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Kimberly Hoagwood, PhD
role: PRINCIPAL_INVESTIGATOR
References: