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Equine Facilitated CBT Group Therapy for Youth Anxiety

Primary Purpose

Anxiety

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Augmented equine-facilitated CBT group program
TAU is equine-facilitated group therapy
WLC
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept 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)

Sites / Locations

  • NYU Langone Health

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Other

Arm Label

Equine-facilitated group therapy

Augmented equine-facilitated CBT group program

Wait List Control (WLC)

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
February 11, 2019
Last Updated
September 28, 2020
Sponsor
NYU Langone Health
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1. Study Identification

Unique Protocol Identification Number
NCT03838835
Brief Title
Equine Facilitated CBT Group Therapy for Youth Anxiety
Official Title
Equine Facilitated Cognitive Behavioral Therapy (CBT) Group Therapy for Youth Anxiety
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Terminated
Why Stopped
COVID-19
Study Start Date
November 15, 2018 (Actual)
Primary Completion Date
May 26, 2020 (Actual)
Study Completion Date
May 26, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Equine-facilitated group therapy
Arm Type
Experimental
Arm Title
Augmented equine-facilitated CBT group program
Arm Type
Experimental
Arm Title
Wait List Control (WLC)
Arm Type
Other
Intervention Type
Behavioral
Intervention Name(s)
Augmented equine-facilitated CBT group program
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
TAU is equine-facilitated group therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
WLC
Intervention Description
WLC consists of youth who are not yet receiving any services at Gallop NYC.
Primary Outcome Measure Information:
Title
Anxiety, as measured by the SCARED
Description
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).
Time Frame
Baseline to 10 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kimberly Hoagwood, MD
Organizational Affiliation
New York Langone Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

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Equine Facilitated CBT Group Therapy for Youth Anxiety

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