Evaluating the Impact of Reining in Anxiety

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluating the Impact of Reining in Anxiety on Childhood Anxiety

Conditions
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Anxiety, Anxiety Disorder

Intervention / Treatment
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* Behavioral: Manualized equine assisted therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Before Session 1 (baseline) , After Session 10 ( after 6 months) | 
| 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. | Before Session 1 (baseline) , After Session 10 ( after 6 months) | 
| 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. | Before Session 1 (baseline) , After Session 10 ( after 6 months) | 
| 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. | Before Session 1 (baseline) , After Session 10 ( after 6 months) | 
| 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. | Before Session 1 (baseline) | 
| 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. | After sessions 1 (baseline), 4 (2 months), 7 (4 months), and 10 (after 6 months) | 
| 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 | After Session 10 (after 6 months) | 
| Perception of instructor's satisfaction | A Satisfaction Questionnaire administered at posttest will assess the instructors' satisfaction with training and delivery of the intervention. | After Session 10 (after 6 months) |