NCT03838835

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P25-P50 for not_applicable anxiety

Timeline
Completed

Started Nov 2018

Typical duration for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 11, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 12, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 26, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 26, 2020

Completed
Last Updated

September 30, 2020

Status Verified

September 1, 2020

Enrollment Period

1.5 years

First QC Date

February 11, 2019

Last Update Submit

September 28, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

Equine-facilitated group therapy

EXPERIMENTAL
Behavioral: TAU is equine-facilitated group therapy

Augmented equine-facilitated CBT group program

EXPERIMENTAL
Behavioral: Augmented equine-facilitated CBT group program

Wait List Control (WLC)

OTHER
Other: WLC

Interventions

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.

Augmented equine-facilitated CBT group program

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.

Equine-facilitated group therapy
WLCOTHER

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

Wait List Control (WLC)

Eligibility Criteria

Age6 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Kimberly Hoagwood, MD

    New York Langone Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2019

First Posted

February 12, 2019

Study Start

November 15, 2018

Primary Completion

May 26, 2020

Study Completion

May 26, 2020

Last Updated

September 30, 2020

Record last verified: 2020-09

Locations