Yoga Therapy and Oppositional Defiant Disorder Behaviors

NCT05865067 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2023-10-04

No results posted yet for this study

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.

Conditions

  • Oppositional Defiant Disorder in Children
  • Oppositional Defiant Disorder

Interventions

OTHER

Yoga Therapy

The intervention sessions will consist of 12 yoga therapy sessions, each one approximately 30 to 45 minutes long, it will be given once a week (on Saturdays) in a room in the building of the School of Health Professions in the Campus of Medical Sciences from the University of Puerto Rico.

OTHER

Exercise

The wait-list control group will be motivated to exercise at home (except for Yoga).

Sponsors & Collaborators

  • Substance Abuse and Mental Health Services Administration (SAMHSA)

    collaborator FED
  • American Psychiatric Association

    collaborator OTHER
  • National Institute on Minority Health and Health Disparities (NIMHD)

    collaborator NIH
  • University of Puerto Rico

    lead OTHER

Principal Investigators

  • Karen G Martínez, MD, MSc · University of Puerto Rico Department of Psychiatry

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
4 Years
Max Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-01
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • Puerto Rico

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05865067 on ClinicalTrials.gov