AnxietyNCT04825756
Evaluating the Impact of Reining in Anxiety
A study testing Manualized equine assisted therapy in people with Anxiety and Anxiety Disorder, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Anxiety Disorder
- What is being tested?
- Manualized equine assisted therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Feb 2021to 1 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- An inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Impact of Reining in Anxiety on Childhood Anxiety
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.
Read the 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.
- Conditions
- Anxiety, Anxiety Disorder
- Being tested
- Manualized equine assisted therapy
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manualized equine assisted therapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Manualized equine assisted therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: Before Session 1 (baseline) , After Session 10 ( after 6 months)
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: After Session 10 (after 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start22 Feb 2021
- Primary completion1 Sep 2021
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kimberly Hoagwood, PhD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04825756
- Sponsor's protocol ID
- 21-00055
- Status last verified
- Feb 2022
- First submitted
- 23 Mar 2021
- Last updated
- 10 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Pilot study data only
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Impact of Reining in Anxiety on Childhood Anxiety
- ClinicalTrials.gov ID
- NCT04825756
- Acronym / sponsor ID
- 21-00055
- Conditions
- Anxiety, Anxiety Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 22 Feb 2021 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 1 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Behavioral: Manualized equine assisted therapyA 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. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- An inability to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manualized equine assisted therapyThis 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. | Behavioural | Treatment Group |
Primary outcome
Change in levels of Anxiety
Time frame: Before Session 1 (baseline) , After Session 10 ( after 6 months)
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
Time frame: Before Session 1 (baseline) , After Session 10 ( after 6 months)
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).
8 secondary outcomes
Change in children's emotional regulation
Time frame: Before Session 1 (baseline) , After Session 10 ( after 6 months)
Change in parents' perception of children's emotional regulation
Time frame: Before Session 1 (baseline) , After Session 10 ( after 6 months)
Change in emotional self efficacy
Time frame: Before Session 1 (baseline) , After Session 10 ( after 6 months)
Change in the level of knowledge of anxiety
Time frame: Before Session 1 (baseline) , After Session 10 ( after 6 months)
Traumatic events of children
Time frame: Before Session 1 (baseline)
Perception of child's feelings to the horse
Time frame: After sessions 1 (baseline), 4 (2 months), 7 (4 months), and 10 (after 6 months)
Perception of caregivers satisfaction
Time frame: After Session 10 (after 6 months)
Perception of instructor's satisfaction
Time frame: After Session 10 (after 6 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2022.
- Individual participant dataSharing planned: No. Pilot study data only
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kimberly Hoagwood, PhD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manualized equine assisted therapy in people with Anxiety and Anxiety Disorder, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in levels of Anxiety (time frame: Before Session 1 (baseline) , After Session 10 ( after 6 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2022.