Equine Facilitated CBT Group Therapy for Youth Anxiety

Equine Facilitated Cognitive Behavioral Therapy (CBT) Group Therapy for Youth Anxiety

The purpose of this study is to evaluate a 10-week equine facilitated cognitive behavioral therapy (CBT) group program for youth between ages of 6 to 17 with symptoms of anxiety. The program will be delivered at GallopNYC, a stable that provides equine-facilitated group therapy to youth with a range of mental health problems.

Study Overview

• Status: Terminated
• Conditions: Anxiety
• Intervention / Treatment: Behavioral: TAU is equine-facilitated group therapy; Behavioral: Augmented equine-facilitated CBT group program; Other: WLC

Detailed Description

The equine-facilitated group therapy normally provided at GallopNYC (Treatment as Usual, TAU) will be compared to an augmented group program that will include CBT strategies, including psychoeducation to the child and caregiver about anxiety, coping strategies to use when anxious, and identifying and addressing dysfunctional thoughts that maintain anxiety. Seventy-five children between 6 to 17 years of age will be randomized to TAU (equine-facilitated group therapy), the augmented group therapy that contains CBT strategies, or wait list control. Outcomes include anxiety symptoms, self-efficacy,receipt of services, functioning and the child's relationship with the horse.

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• A child aged 6-17 seeking services for anxiety at Gallop NYC, who (based on the screener administered by GallopNYC) evidence symptoms of anxiety (as measured by a score of 2 or more on the GAD 2 item questionnaire) and a minimum functioning score of 51 (as measured by the child global assessment scale)
• Caregivers will also serve as study respondents. To do so, they must meet the following criteria:
• Primary caregiver/ legal guardian of a child who meets eligibility criteria
• Aged 18 years or older
• English speaking

Providers will serve as study therapists. To do so, they must meet the following criteria:

• PATH-certified provider employed at Gallop NYC

Exclusion Criteria:

• Inability to provide informed consent
• Child does not meet criteria for anxiety symptoms (as measured by a score of 2 or more on the GAD 2 item questionnaire) and/or does not meet minimum level of functioning (does not meet a minimum functioning score of 51 as measured by the child global assessment scale)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Equine-facilitated group therapy	Behavioral: TAU is equine-facilitated group therapy; TAU is equine-facilitated group therapy at GallopNYC, which consists of horseback riding and integrates strategies to support the development of cognitive, physical, emotional, and social skills.
Experimental: Augmented equine-facilitated CBT group program	Behavioral: Augmented equine-facilitated CBT group program; Consists of CBT strategies including 1) providing psychoeducation about anxiety, 2) teaching coping strategies when anxious,and 3) identifying and addressing dysfunctional thoughts that maintain anxiety.
Other: Wait List Control (WLC)	Other: WLC; WLC consists of youth who are not yet receiving any services at Gallop NYC.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety, as measured by the SCARED	41 item questionnaire scored on a 3-point Likert Scale ranging from "not true" to "very true." Items are summed, with higher scores indicating more anxiety symptoms (a cutoff of 25 indicates an anxiety disorder).	Baseline to 10 Weeks

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Kimberly Hoagwood, MD, New York Langone Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2018
• Primary Completion (Actual): May 26, 2020
• Study Completion (Actual): May 26, 2020

Study Registration Dates

• First Submitted: February 11, 2019
• First Submitted That Met QC Criteria: February 11, 2019
• First Posted (Actual): February 12, 2019

Study Record Updates

• Last Update Posted (Actual): September 30, 2020
• Last Update Submitted That Met QC Criteria: September 28, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 18-01424

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No