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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03838835
Other study ID # 18-01424
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date November 15, 2018
Est. completion date May 26, 2020

Study information

Verified date September 2020
Source NYU Langone Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 59
Est. completion date May 26, 2020
Est. primary completion date May 26, 2020
Accepts healthy volunteers No
Gender All
Age group 6 Years to 17 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.
Other:
WLC
WLC consists of youth who are not yet receiving any services at Gallop NYC.

Locations

Country Name City State
United States NYU Langone Health New York New York

Sponsors (1)

Lead Sponsor Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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