Clinical trial NCT05865067: Yoga Therapy and Oppositional Defiant Disorder Behaviors
Official title: Yoga Therapy for Latino Preschool Children With Oppositional Defiant Behaviors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Oppositional Defiant Disorder in Children
Oppositional Defiant Disorder
Keywords: yoga
yoga therapy
preschool
odd
oppositional defiant disorder
latino
children
Lead sponsor: University of Puerto Rico
Sponsor class: OTHER
Collaborators: name: Substance Abuse and Mental Health Services Administration (SAMHSA)
name: American Psychiatric Association
name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2023-05-18
Enrollment: 34
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This is a Pilot efficacy, randomized intervention, wait-list controlled clinical trial to evaluate the feasibility of Yoga Therapy for Latino Preschool children aged 4 to 6 years old with ODD. This design makes it comparable to the pilot efficacy study done in the same age and diagnostic group by Dr. Matos, which evaluated PCIT efficacy. We will recruit participants by flyers to obtain 34 patients and 68 parents; after confirming ODD trait with DBRS, they will be randomized to intervention and wait-list control groups. Randomization will be performed in a 3:2 ratio (Yoga-Therapy: Wait-List; 21:13). Flyers, newspapers, radio, and television ads will recruit participants.
Primary purpose: TREATMENT

Brief summary: This clinical trial aims to learn about, test, and compare the effect yoga therapy has on improving disruptive behaviors (e.g., oppositional defiant disorder) in Latino preschool children and parent-child interactions.

The main question\[s\] it aims to answer are:

* Can Yoga Therapy improve disruptive behaviors in Latino preschool children with Oppositional Defiant Disorder traits?
* Can Yoga Therapy improve parent-child interactions in Latino preschool children with Oppositional Defiant Disorder traits?

Participants will:

* Complete an initial survey to screen for inclusion and exclusion factors
* Fill out two questionnaires and consent form at the first visit
* Fill out four questionnaires on orientation day (day 2)
* Receive orientation and receive an educational pamphlet on the 2nd and 15th (closing) days
* Participate in the 12 Yoga sessions with a weekly call to remind them of their appointment
* Fill out a questionnaire on day 8 (6th yoga class)
* Fill out five questionnaires on the 15th (closing)
* Receive a possible assessment of the child's heartbeat at the 12 intervention sessions (will be randomly selected) with a heart rate variability monitor
* Receive an evaluation of the child's sweating at the first visit (orientation) and visit 15 (closing)
* Participate in a last visit to finish and offer additional information (day 15; closing)
* Participate in a telephone survey three months (day 16) after completing the study.

Control group participation will consist of:

* Fill a telephone survey to screen for inclusion and exclusion factors
* Fill out two questionnaires and informed consent at the first visit
* Fill out four questionnaires in the second meeting (day 2 of orientation)
* Fill out six questionnaires in the last meeting (day 15; closure)
* Receive a 30-45 minute video orientation and psychoeducation (where they will also receive an educational brochure) and a series of exercise recommendations for parent and children on day 2 (orientation)
* Receive 12 phone calls (once a week) to remind them to exercise and evaluate if they exercised the week before
* Receive an evaluation of the child's sweating at the first visit (orientation) and last visit (day 15; closure)
* Receive an evaluation of the child's heart rhythm at the first visit (orientation) and last visit (day 15; closure)
* Fill out a telephone survey (day 16; follow-up) three months after completing the study
* Receive a call at the end of the study to coordinate the Yoga sessions for parents and children once the intervention group has completed their participation.

Researchers will compare Yoga therapy to exercise to see if there is a change in disruptive behaviors and parent-child interactions.

Detailed description: In the process of obtaining the 34 participants and their respective fathers/mothers, they will be randomly divided between the two possible groups (YogaTherapy or Psycho-Education). This will be done through the recruitment process as follows: the first child listed will go to the intervention group, the second to the waiting list, the third to the intervention, the fourth to the waiting list, and so on. The same will be done for the girls: the first to the intervention group, the second to the waiting list, etc.

The intervention group:

In the first face-to-face meeting, you will complete five questionnaires \[Your Child's Medical History, Disruptive Behavior Scale, Parenting Questionnaire-Preschool Edition, Parent Stress Index-Short Version, Sense of Parenting\]. You will do a baseline assessment of your child's heartbeat and sweating. Once the intervention sessions begin, they will participate in 12 sessions, each approximately 30 to 45 minutes long, which will occur once a week (on Saturdays) in a room in the School of Health Professions building at the Medical Sciences Campus of the University of Puerto Rico. Later on, you will be told the room and the floor where you are staying and where you will receive the intervention: it will always be the same day, at the same time.

* In 12 sessions, the child's heart rate will be evaluated with a monitor that will be placed on his ear (this measurement will only be done to one child out of the possible five who will be taking his session. It will be determined randomly which child will receive an evaluation of your heart rhythm)
* In 4 sessions, you will complete the DBRS questionnaire (disruptive behavior scale - Spanish version).
* In the first session, you will fill out five questionnaires \[Your Child's Medical History, Disruptive Behaviors Scale, Parenting Questionnaire-Preschool Edition, Parenting Stress Index-Short Version, Sense of Parenting\] and assess your child's heart rate and sweating
* In the last session, you will complete five questionnaires \[Disruptive Behavior Scale, Parenting Questionnaire-Preschool Edition, Parent Stress Index-Short Version, Sense of Competence as a Parent, Assessment of Therapy Offered\] and assess your heart rate and your child's sweating one last time. Sweating will be measured with a machine where a Velcro ring will be placed on the ring finger of your non-right hand.
* You must wear a mask at all times. All staff will be wearing a mask at all times. Products will be disinfected with chlorine before and after each session.

Your total participation in the study (in the intervention group) will consist of 3 face-to-face months (one Saturday a week) up to a total of 6 months and 3 weeks if we include orientation day, closing day, and the call at 3 months after completing the study.

The control group:

* In the first face-to-face meeting, you will fill out six questionnaires \[Your Child's Medical History, Disruptive Behaviors Scale, Parenting Questionnaire-Preschool Edition, Parenting Stress Index-Short Version, Sense of Competence as a Parent, Evaluation of therapy offered\] and a baseline assessment of your child's heartbeat and sweating will be done.
* In 3 sessions, you will complete the DBRS questionnaire (disruptive behavior scale - Spanish version).
* In the first session, you will fill out five questionnaires \[Your Child's Medical History, Disruptive Behaviors Scale, Parenting Questionnaire-Preschool Edition, Parenting Stress Index-Short Version, Sense of Parenting\] and assess your child's heart rate and sweating
* In the last session, you will fill out five questionnaires \[Disruptive Behavior Scale, Parenting Questionnaire-Preschool Edition, Parent Stress Index-Short Version, Sense of Competence as a Parent, Assessment of Therapy Offered\], and we will assess your heart rate and your child's sweating one last time. Sweating will be measured with a machine where a Velcro ring will be placed on the ring finger of your non-right hand.

Their total participation in the study (in the waiting list group) consists of 3 face-to-face weeks - for the screening day, orientation day, and closing day up to a total of 6 months, considering the call 3 months after finishing the study.

This is an experimental study where the Yoga intervention will be compared with the waiting list (control group), and Yoga Therapy will be compared to Psychoeducation. To participate in our study, you have to give permission to videotape the sessions. Each session will be recorded with video to improve the intervention, to be able to transcribe the ideas expressed (anonymously), control the quality of each intervention and ensure the fidelity of the instructors to the manual; each recording will be labeled with your identifier code, without any personal information that can identify you or your child. Once the investigation is completed, the recordings will be kept for five years at the Center for the Study and Treatment of Fear and Anxiety (CETMA) under the custody of Dr. Karen Martínez in office 236 of the Health Professions Studies Building at the Medical Sciences Campus of the University of Puerto Rico. Electronic and paper data will be stored in the mentioned office for five years. Electronic data will be erased after five years, and the hard drive will be formatted after erasing the data. Data on paper is shredded.

Eligibility criteria: Inclusion Criteria:

* The child is between the ages of 4 to 6 years
* The child has oppositional defiant disorder (ODD) traits
* The child is not under pharmacological treatment for oppositional defiant disorder (ODD)

Exclusion Criteria:

* The child has speech or hearing problems
* The child has a history of developmental disorders (severe)
* The child is using pharmacotherapy - psychoactive medications
* Parents are not willing to put psychological treatments on hold while they are in this study
* The child is or has received training in yoga
* The parents, legal guardians, or the person in charge have problematic use of substances.
* There is a history of mental or physical abuse in the home \[If identified, the referral protocol will be activated\]
* The child is less than four years old or older than six years old

Primary outcomes:
measure: Disruptive Behavior Disorder Rating Scale (DBRS)
timeFrame: 15 weeks
Secondary outcomes:
measure: Alabama Parenting Questionnaire Preschool Version (APQ-Pr)
timeFrame: 15 weeks
measure: Parenting Stress Index, Short Form (PSI-SF)
timeFrame: 15 weeks
measure: Parent Sense of Competence Scale (PSOC)
timeFrame: 15 weeks
measure: Therapy Evaluation Scale (TES)
timeFrame: 15 weeks
measure: Heart rate variability (HRV)
timeFrame: 15 weeks
Other outcomes:
Locations:
city: San Juan
country: Puerto Rico
facility: University of Puerto Rico Medical Sciences Campus
Study officials:
affiliation: University of Puerto Rico Department of Psychiatry
name: Karen G Martínez, MD, MSc
role: PRINCIPAL_INVESTIGATOR
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