Pilot Study Examining Adaptation of EAT-PTSD (the MOW Protocol) for Anxious Youth
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Children's Global Assessment Scale (CGAS)
研究概览
简要总结
The purpose of this research protocol is to adapt the Equine Assisted Therapy (EAT) protocol, which the investigators had developed to help treat PTSD (EAT-PTSD; the Man O' War (MOW) protocol), for use with adolescents who have an anxiety disorder.
The MOW protocol is an eight session, group therapy EAT protocol, which the investigators developed, piloted, revised, and tested. EAT is an alternative treatment practiced across the United States and around the world for mental health disorders, in which the horse(s) play an essential role in an experientially oriented therapeutic approach. The MOW protocol is for group EAT, with groups led by a licensed mental health provider and an "equine specialist," working with two horses and assisted by a wrangler (horse handler) to assure safety. In the open trial, the MOW protocol showed promising results in reducing the level of PTSD and Depressive symptoms in veterans with moderate to severe PTSD, was found to be safe (no adverse events), and well accepted (very few dropouts (Fisher et al., 2021)) and found evidence of neural changes (Zhu et al, 2021). As part of the MOW project, the investigators prepared a well specified treatment manual (Fisher et al, 2021) - the first of its kind in the field of EAT - and have trained others in its use.
详细描述
In this pilot study the investigators will explore the use/adaptation of the EAT-PTSD protocol that the investigators developed to treat veterans with Posttraumatic Stress Disorder so that it might be used with adolescents with anxiety disorders.
Potential participant Identification:
The first group of potential participants will be identified from the "waiting list" at CUCARD Westchester. Currently CUCARD clinic has very limited clinician availability and maintains a waitlist of up to 30 adolescents who are (or whose family are on their behalf) seeking treatment at CUCARD. The clinic's intake coordinator undertakes a basic screen with families who call and gets a basic description of the youth's symptoms (chief complaint), his/her address, current school, history of suicidal behavior and self-harm, violence, aggression, substance use, treatment history, previous diagnoses, medical problems, etc.
Clinic staff will review the waiting list for youth who are judged to be likely eligible, to help recruit the first group of six adolescents, with efforts made to have at least two of each gender in every group (and ideally balance groups by gender). To do this the investigators will start by preferentially selecting youth who: 1) live in closer proximity to the equestrian center which is in Brewster (using their address) and 2) do not attend the same school as other participants who have been included (i.e., one per school if possible), until the investigators fill a group.
For each potential participant, a clinic staff member will call their parents to let them know that the youth may be eligible for a new small study of the use of Equine Assisted Therapy for Youth who are anxious, that is being carried out on Wednesday afternoons (for Group 1 - for Group 2, it may be a different day), in collaboration with the Division of Child Psychiatry at Columbia. (NOTE: It is a usual practice at the clinic to "check-in" with families on the waiting list, to see how they are managing, whether they need a referral, etc.).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Youth ages 13-17
- •Youth lives with parent
- •English speaking (youth and parent) who reside in Westchester, Putnam, Rockland, Bronx, or Manhattan Counties (in New York) OR in Connecticut
- •Youth does not have a current substance use problem
- •Youth is available for an "after school" group at time the EAT sessions are scheduled
- •Parent understands that participation does not affect place on clinic waiting list
- •Parent will be able to provide/assure transportation to equestrian center, etc.
- •Current diagnosis of Social Anxiety Disorder, Separation Anxiety Disorder, Generalized Anxiety Disorder, or Unspecified Anxiety Disorder
- •Parent understands the protocol, agrees to their responsibilities (providing transport, scheduling sessions), and is able to give consent
- •Youth understands the protocol and consents (if age 18) or assents (if younger than age 18) of their own free will
排除标准
- •Elevated depression, PTSD, or OCD symptoms of clinical concern
- •Elevated risk for suicide/suicidal behavior based on history and current mental state
- •Extreme fear of horses
- •Orthopedic or other physical limitation that would prevent youth from walking unassessed and/or walking freely in ring
- •Acute, unstable, or severe medical disorder (that might prohibit completing the 8 session protocol)
结局指标
主要结局
Children's Global Assessment Scale (CGAS)
时间窗: 2 minutes
A clinician rating of a child's social and psychological functioning
Pediatric Anxiety Rating Scale - Global Ratings (PARS)
时间窗: 5 minutes
A clinician-rated measure of symptom severity and associated impairment that targets generalized anxiety disorder, social phobia, and separation anxiety disorder
Screen for Child Anxiety Related Disorders (SCARED) - Youth
时间窗: 4 minutes
A child self-report instrument used to screen for childhood anxiety disorders including general anxiety disorder, separation anxiety disorder, panic disorder and social phobia
Screen for Child Anxiety Related Disorders (SCARED) - Parent
时间窗: 4 minutes
A parent/other administered scale that aids in the diagnosis of panic disorder/significant somatic symptoms, generalized anxiety disorder, separation anxiety disorder, social anxiety disorder, and significant school avoidance
Clinical Global Impressions - Improvement Scale (CGI-I)
时间窗: 2 minutes
A scale that rates the degree of clinical improvement at the time of assessment, relative to how the patient was at entry (Score from 1-7)
次要结局
- Mood and Feelings Questionnaire - Youth Long Form(5 minutes)
- Columbia Impairment Scale - Parent Form(2 minutes)
- Anxiety Disorders Interview Schedule - Child and Parent (ADIS-C)(160 minutes)
- Patient-Reported Outcomes Measurement Information System (PROMIS): Short Form 8A - Family Relationships (Parent)(2 minutes)
- Mood and Feelings Questionnaire - Parent Long Form(5 minutes)
- Patient-Reported Outcomes Measurement Information System (PROMIS): Short Form 8A - Family Relationships (Child)(2 minutes)
- Adolescent Self Esteem Questionnaire(3 minutes)
研究者
Prudence Fisher
Research Scientist
New York State Psychiatric Institute