Yoga Therapy and Oppositional Defiant Disorder Behaviors

NCT05865067 | Unknown

• 1 other identifier: 2290034907
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Oppositional Defiant Disorder in Children; Oppositional Defiant Disorder

Keywords

yoga; yoga therapy; preschool; odd; oppositional defiant disorder; latino; children

Outcome Measures

Primary Outcomes (1)

• Disruptive Behavior Disorder Rating Scale (DBRS)

  The Disruptive Behavior Scale for Children (DBRS; Spanish Version), is used as a screening and outcome measure. The DBRS will be administered to the intervention and control groups at Day 1, Day 8, Day 14, Day 15, and Day 16 (3-month follow-up). This scale has 41 DSM items on a 4-point scale, answer options include: never or rarely, sometimes, often, or very often, ranging from 0 to 3 points, respectively, using the past six months as a time frame. A total of 3 or more items (DBRS-ODD) must be marked as "often" or "very often" by parents to meet the inclusion criteria for an ODD trait. The outcome for DBRS is a change from baseline levels between two groups after adjusting for baseline measurements. Dr. Russel Barkley authorized the use of this instrument (Spanish Version).

  15 weeks

Secondary Outcomes (5)

• Alabama Parenting Questionnaire Preschool Version (APQ-Pr)

  15 weeks

• Parenting Stress Index, Short Form (PSI-SF)

  15 weeks

• Parent Sense of Competence Scale (PSOC)

  15 weeks

• Therapy Evaluation Scale (TES)

  15 weeks

• Heart rate variability (HRV)

  15 weeks

Study Arms (2)

Yoga Therapy

EXPERIMENTAL

Participation will consist of 1) a telephone survey to screen for exclusion factors; 2) filling out two questionnaires and consent at the first visit; 3) filling out four questionnaires on orientation day (day 2); 4) receiving an orientation for you and your child and receive an educational pamphlet on the 2nd and 15th (closing); 5) participate in the 12 Yoga sessions with your child (Saturdays) with a weekly call to remind you of your appointment; 6) fill out a questionnaire on day 8 (6th yoga class); 7) fill out five questionnaires on the 15th (closing); 8) a possible assessment of your child's heartbeat at the 12 intervention sessions (will be randomly selected); 9) an evaluation of your child's sweating at the first visit (orientation) and at visit 15 (closing); 10) a last visit to finish and offer additional information (day 15; closing); 11) a telephone survey three months (day 16) after completing the study.

Other: Yoga Therapy

Wait-List with Exercise

ACTIVE COMPARATOR

Participation consists of 1) a telephone survey to screen for exclusion factors; 2) filling out two questionnaires and informed consent at the first visit; 3) filling out four questionnaires in the second meeting (day 2 of orientation); 4) filling out six questionnaires in the last meeting (day 15; closure); 4) receive a 30-45 minute video orientation and psychoeducation (where you will also receive an educational brochure) and a series of exercise recommendations for you and your child on day 2 (orientation); 5) 12 phone calls (once a week); 6) an evaluation of your child's sweating at the first visit (orientation) and last visit (day 15; closure); 7) an evaluation of your child's heart rhythm at the first visit (orientation) and last visit (day 15; closure); 8) a telephone survey (day 16; follow-up) 3 months after completing the study; 9) a call at the end of the study to coordinate the Yoga sessions for you and your child once the first group has finished.

Other: Exercise

Interventions

Yoga Therapy OTHER

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.

Yoga Therapy

Exercise OTHER

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

Wait-List with Exercise

Eligibility Criteria

• Age: 4 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Puerto Rico: lead
• Substance Abuse and Mental Health Services Administration (SAMHSA): collaborator
• American Psychiatric Association: collaborator
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

University of Puerto Rico Medical Sciences Campus

San Juan, PR, 00926, Puerto Rico

RECRUITING

Related Publications (27)

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Related Links

• The American Academy of Child and Adolescent Psychiatry, all rights reseved. (2009). ODD A Guide for Families by the American Academy of Child and Adolescent Psychiatry. Retrieved 2018, from
• Lange, K.M., Maluska-Gertruda, E., Hauser, J., Reissma, A., Kauzinger, I., Tucha, L., … \& Lange, K.W. (2014). Yoga and the therapy of children with attention deficit hyperactivity disorder. Yoga \& Physical Therapy, 4(3), 1000168.
• Hinshaw, S.P., \& Lee, S.S. (2003). Conduct and oppositional defiant disorders. In E.J. Mash \& R.A. Barkley (Eds.), Child psychopathology (3rd ed, pp. 144-198). New York: Guilford Press.
• Psychometric properties of the Alabama parenting questionnaire-preschool revision (APQ-Pr) in 3 year-old Spanish preschoolers. Journal of Child and Family Studies, 23(5)
• Domenech Rodríguez, M. M., Franceschi Rivera, N., Sella Nieves, Z., \& Félix Fermín, J. (2013). Parenting in Puerto Rican families: Mothers and father's self-reported practices. Interamerican Journal of Psychology, 47(2).
• Abidin, R. R. (1990). Parenting stress index-short form (p. 118). Charlottesville, VA: Pediatric Psychology Press.
• Johnston, C., \& Mash, E. J. (1989). A measure of parenting satisfaction and efficacy. Journal of clinical child psychology, 18(2), 167-175
• QuickFacts. (n.d.). Retrieved January, 2018, from

MeSH Terms

Conditions

Oppositional Defiant Disorder

Interventions

Yoga; Exercise

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Karen G Martínez, MD, MSc

  University of Puerto Rico Department of Psychiatry

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karen G Martínez-González, MD, MSc

CONTACT

7877582525; karen.martinez4@upr.edu

Alisha M Subervi-Vázquez

CONTACT

7873634627; alisha.subervi@upr.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 9, 2023
• First Posted: May 18, 2023
• Study Start: June 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: October 4, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

PR (1)