Evaluating the Impact of Reining in Anxiety

NCT04825756 | Completed DMC

• 1 other identifier: 21-00055
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this pilot study is to evaluate the impact of Reining in Anxiety for children with anxiety and their caregivers. A total of up to 80 child/caregiver dyads will be enrolled in the study, anticipating that 40 dyads will complete the 10 week intervention. The intervention will be delivered at Fieldstone Farm Therapeutic Riding Center, which is one of the largest therapeutic riding centers in the US.

Conditions

Anxiety; Anxiety Disorder

Outcome Measures

Primary Outcomes (2)

• Change in levels of Anxiety

  This will be measured by the Generalized Anxiety Disorder-2 (GAD-2) questionnaire which consists of two items that assesses the presence of anxiety. Items are summed, and a score of 3 or higher is usually indicative of further evaluation.

  Before Session 1 (baseline) , After Session 10 ( after 6 months)

• Change in the Psychological functioning

  The Children's Global Assessment Scale (CGAS). The child is given a single score between 1- 100, based on an assessment of a range of aspects related to the child's psychological and social functioning. The score places them in one of ten categories, ranging from "extremely impaired" (1-10) to "doing very well (91-100).

  Before Session 1 (baseline) , After Session 10 ( after 6 months)

Secondary Outcomes (8)

• Change in children's emotional regulation

  Before Session 1 (baseline) , After Session 10 ( after 6 months)

• Change in parents' perception of children's emotional regulation

  Before Session 1 (baseline) , After Session 10 ( after 6 months)

• Change in emotional self efficacy

  Before Session 1 (baseline) , After Session 10 ( after 6 months)

• Change in the level of knowledge of anxiety

  Before Session 1 (baseline) , After Session 10 ( after 6 months)

• Traumatic events of children

  Before Session 1 (baseline)

Study Arms (1)

Treatment Group

EXPERIMENTAL

A total of up to 80 child/caregiver dyads will be enrolled in the study, anticipating that 40 dyads will complete the 10 week intervention. An equine assisted therapy called Reining in Anxiety for children with anxiety and their caregivers.

Behavioral: Manualized equine assisted therapy

Interventions

Manualized equine assisted therapy BEHAVIORAL

This equine assisted therapy (EAT), which is delivered in a group setting, combines therapeutic horseback riding with cognitive behavioral strategies for anxiety. Each 45 minute session is delivered in a group format with up to four children between 6 and 17 years of age. Each session follows the same structure: (1) weekly review; (2) groom and connect; (3) warm-up period; (4) session activity; (5) cool down; (6) parent/caregiver psychoeducation, during which the instructor facilitates psychoeducation; and (7) homework instruction.

Treatment Group

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Caregiver/child dyads where the children are between six and 17 years of age and their caregivers will be enrolled in the study.
• Children must have a score of 3 or higher as measured by the GAD-2,
• Children must have a minimum level of functioning as measured by the CGAS of 41 or higher.

You may not qualify if:

• An inability to provide informed consent

Sponsors & Collaborators

• NYU Langone Health: lead

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, PhD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2021
• First Posted: April 1, 2021
• Study Start: February 22, 2021
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: February 10, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)