Equine Facilitated CBT Group Therapy for Youth Anxiety

Sponsor

NYU Langone Health (Other)

Overall Status

Terminated

CT.gov ID

NCT03838835

Collaborator

(none)

Enrollment

Location

Arms

18.3

Actual Duration (Months)

3.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Anxiety	Behavioral: Augmented equine-facilitated CBT group program Behavioral: TAU is equine-facilitated group therapy Other: WLC	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

59 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 15, 2018

Actual Primary Completion Date :

May 26, 2020

Actual Study Completion Date :

May 26, 2020

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Anxiety, as measured by the SCARED [Baseline to 10 Weeks]
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NYU Langone Health	New York	New York	United States	10016

Sponsors and Collaborators

NYU Langone Health

Investigators

Principal Investigator: Kimberly Hoagwood, MD, New York Langone Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

NYU Langone Health

ClinicalTrials.gov Identifier:

NCT03838835

Other Study ID Numbers:

18-01424

First Posted:

Feb 12, 2019

Last Update Posted:

Sep 30, 2020

Last Verified:

Sep 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Anxiety Disorders

Study Results

No Results Posted as of Sep 30, 2020