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Evaluating the Impact of Reining in Anxiety

Primary Purpose

Anxiety, Anxiety Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Manualized equine assisted therapy
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 SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • An inability to provide informed consent

Sites / Locations

  • NYU Langone Health

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment Group

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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).

Secondary Outcome Measures

Change in children's emotional regulation
This will be measured by the Children's Sadness Management Scale (CSMS) which was developed to assess children's inhibition, dysregulated expression, and coping with sadness experience and expression developed to assess three dimensions of sadness management. Children respond to 12 items on a 3-point scale (1: hardly ever, 2: sometimes, 3: often). This scale was modified to focus on dealing with anxiety rather than sadness.
Change in parents' perception of children's emotional regulation
This is measured by the Emotion Regulation Checklist (ERC- full scale). The ERC is a 24-item questionnaire using a 4-point Likert scale that was used to assess parents' perceptions of their child's ability to manage emotion. This measure yields two empirically derived scales: (a) Emotion Regulation that assesses situationally appropriate affective displays and emotional self-awareness and (b) Lability/Negativity, which measures mood lability and culturally inappropriate affective displays. two additional questions were added about how long it takes children to regulate.
Change in emotional self efficacy
This is measured by the Self-Efficacy Questionnaire for Children, emotional self-efficacy subscale (SEQ-C). The scale was modified the SEQ-C, which has 24 questions regarding 3 domains of self-efficacy, to utilize only the eight emotional self-efficacy items to assess parent's beliefs regarding their children's competence in controlling negative emotions. Items are scored using a 5- point Likert scale ranging from "not at all (1)" to "very well (5)." Higher scores indicate greater self-efficacy. Parents/caregivers of youth enrolled in the study completed this measure both pre and post-intervention.
Change in the level of knowledge of anxiety
Knowledge of anxiety scale was developed by the study's researchers to assess the knowledge of anxiety from child and parent before and after the intervention, attempting to measure what has been learned in psychoeducation about anxiety.
Traumatic events of children
Traumatic events will be measured by the CYW Adverse Childhood Experiences Questionnaire (ACE-Q) Child, to be completed by parent/caregiver. The measure involves a list of statements of traumatic events in two sections, and parents adding up the number of statements that apply to their child. Section 1 has 10 statements, and Section 2 has 7 statements.
Perception of child's feelings to the horse
Modified Center for the Study of Animal Wellness Scale will be used to gauge how the children feel about the horse. Attachment to the horse will be measured by the modified Center for the Study of Animal Wellness CSAW Pet B, which is a 27-item self-report measure of children's attachment. The measure presents three descriptions of feelings/perceptions about the child's relationship to the horse.
Perception of caregivers satisfaction
Caregiver Satisfaction Questionnaire delivered at posttest will assess the caregiver's satisfaction with they and their child's involvement in the program
Perception of instructor's satisfaction
A Satisfaction Questionnaire administered at posttest will assess the instructors' satisfaction with training and delivery of the intervention.

Full Information

First Posted
March 23, 2021
Last Updated
February 8, 2022
Sponsor
NYU Langone Health
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1. Study Identification

Unique Protocol Identification Number
NCT04825756
Brief Title
Evaluating the Impact of Reining in Anxiety
Official Title
Evaluating the Impact of Reining in Anxiety on Childhood Anxiety
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
February 22, 2021 (Actual)
Primary Completion Date
September 1, 2021 (Actual)
Study Completion Date
September 1, 2021 (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
Yes

5. Study Description

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.
Detailed Description
Reining in Anxiety is a manualized equine assisted therapy (EAT) for childhood anxiety. The manual and associated materials are being tested in this pilot study, and, if found to be successful, will be available for public consumption. This EAT, which is delivered in a group setting, combines therapeutic horseback riding with cognitive behavioral strategies for anxiety. The group meets weekly over the course of ten weeks, with each session lasting 45 minutes. Each session is delivered in a group format with up to four children between 6 and 17 years of age.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Manualized equine assisted therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in levels of Anxiety
Description
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.
Time Frame
Before Session 1 (baseline) , After Session 10 ( after 6 months)
Title
Change in the Psychological functioning
Description
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).
Time Frame
Before Session 1 (baseline) , After Session 10 ( after 6 months)
Secondary Outcome Measure Information:
Title
Change in children's emotional regulation
Description
This will be measured by the Children's Sadness Management Scale (CSMS) which was developed to assess children's inhibition, dysregulated expression, and coping with sadness experience and expression developed to assess three dimensions of sadness management. Children respond to 12 items on a 3-point scale (1: hardly ever, 2: sometimes, 3: often). This scale was modified to focus on dealing with anxiety rather than sadness.
Time Frame
Before Session 1 (baseline) , After Session 10 ( after 6 months)
Title
Change in parents' perception of children's emotional regulation
Description
This is measured by the Emotion Regulation Checklist (ERC- full scale). The ERC is a 24-item questionnaire using a 4-point Likert scale that was used to assess parents' perceptions of their child's ability to manage emotion. This measure yields two empirically derived scales: (a) Emotion Regulation that assesses situationally appropriate affective displays and emotional self-awareness and (b) Lability/Negativity, which measures mood lability and culturally inappropriate affective displays. two additional questions were added about how long it takes children to regulate.
Time Frame
Before Session 1 (baseline) , After Session 10 ( after 6 months)
Title
Change in emotional self efficacy
Description
This is measured by the Self-Efficacy Questionnaire for Children, emotional self-efficacy subscale (SEQ-C). The scale was modified the SEQ-C, which has 24 questions regarding 3 domains of self-efficacy, to utilize only the eight emotional self-efficacy items to assess parent's beliefs regarding their children's competence in controlling negative emotions. Items are scored using a 5- point Likert scale ranging from "not at all (1)" to "very well (5)." Higher scores indicate greater self-efficacy. Parents/caregivers of youth enrolled in the study completed this measure both pre and post-intervention.
Time Frame
Before Session 1 (baseline) , After Session 10 ( after 6 months)
Title
Change in the level of knowledge of anxiety
Description
Knowledge of anxiety scale was developed by the study's researchers to assess the knowledge of anxiety from child and parent before and after the intervention, attempting to measure what has been learned in psychoeducation about anxiety.
Time Frame
Before Session 1 (baseline) , After Session 10 ( after 6 months)
Title
Traumatic events of children
Description
Traumatic events will be measured by the CYW Adverse Childhood Experiences Questionnaire (ACE-Q) Child, to be completed by parent/caregiver. The measure involves a list of statements of traumatic events in two sections, and parents adding up the number of statements that apply to their child. Section 1 has 10 statements, and Section 2 has 7 statements.
Time Frame
Before Session 1 (baseline)
Title
Perception of child's feelings to the horse
Description
Modified Center for the Study of Animal Wellness Scale will be used to gauge how the children feel about the horse. Attachment to the horse will be measured by the modified Center for the Study of Animal Wellness CSAW Pet B, which is a 27-item self-report measure of children's attachment. The measure presents three descriptions of feelings/perceptions about the child's relationship to the horse.
Time Frame
After sessions 1 (baseline), 4 (2 months), 7 (4 months), and 10 (after 6 months)
Title
Perception of caregivers satisfaction
Description
Caregiver Satisfaction Questionnaire delivered at posttest will assess the caregiver's satisfaction with they and their child's involvement in the program
Time Frame
After Session 10 (after 6 months)
Title
Perception of instructor's satisfaction
Description
A Satisfaction Questionnaire administered at posttest will assess the instructors' satisfaction with training and delivery of the intervention.
Time Frame
After Session 10 (after 6 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: An inability to provide informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kimberly Hoagwood, PhD
Organizational Affiliation
NYU Langone Health
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

Plan to Share IPD
No
IPD Sharing Plan Description
Pilot study data only

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Evaluating the Impact of Reining in Anxiety

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