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Equine Facilitated CBT Group Therapy for Youth Anxiety

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03838835
Recruitment Status : Terminated (COVID-19)
First Posted : February 12, 2019
Last Update Posted : September 30, 2020
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : November 15, 2018
Actual Primary Completion Date : May 26, 2020
Actual Study Completion Date : May 26, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

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.

Wait List Control (WLC) Other: WLC
WLC consists of youth who are not yet receiving any services at Gallop NYC.




Primary Outcome Measures :
  1. Anxiety, as measured by the SCARED [ Time Frame: 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03838835


Locations
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United States, New York
NYU Langone Health
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Kimberly Hoagwood, MD New York Langone Medical Center
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT03838835    
Other Study ID Numbers: 18-01424
First Posted: February 12, 2019    Key Record Dates
Last Update Posted: September 30, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders