YTODD: Yoga Therapy and Oppositional Defiant Disorder Behaviors

Sponsor

University of Puerto Rico (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05865067

Collaborator

Substance Abuse and Mental Health Services Administration (SAMHSA) (U.S. Fed), American Psychiatric Association (Other), National Institute on Minority Health and Health Disparities (NIMHD) (NIH)

Enrollment

Location

Arms

Anticipated Duration (Months)

4.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Oppositional Defiant Disorder in Children Oppositional Defiant Disorder	Other: Yoga Therapy Other: Exercise	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

34 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

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.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.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Yoga Therapy for Latino Preschool Children With Oppositional Defiant Behaviors

Anticipated Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Yoga Therapy 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 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.
Active Comparator: Wait-List with Exercise 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 The wait-list control group will be motivated to exercise at home (except for Yoga).

Arm

Intervention/Treatment

Experimental: Yoga Therapy

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

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.

Active Comparator: Wait-List with Exercise

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

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

Outcome Measures

Primary Outcome Measures

Disruptive Behavior Disorder Rating Scale (DBRS) [15 weeks]
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).

Secondary Outcome Measures

Alabama Parenting Questionnaire Preschool Version (APQ-Pr) [15 weeks]
The APQ is a 42-item self-report measure of parenting characteristics, which have been associated with disruptive behaviors for children 6 to 13 years of age. The items are categorized into five subscales reflective of parenting practices; Parents report how frequently they use the described parenting strategies: positive parental involvement, positive parenting discipline techniques, poor monitoring/supervision, inconsistent discipline, and corporal punishment; items are rated on a 5-point Likert-scale (1 = Never to 5 = Always). Various studies have tested the scale reliability; internal consistency for all scales ranges from .80 to .46, while temporal stability ranges from .89 to .6929,30,39. Alpha scores range from .86 to .5429. There is a Spanish version available. Clerkin et al. (2007) adapted this instrument for Preschool children (APQ-Pr).
Parenting Stress Index, Short Form (PSI-SF) [15 weeks]
Parenting Stress Index, Short Form (PSI-SF) measures parenting stress via a 36-item self-report measure. Parents report their agreement with each statement in a 5-point Likert Scale ("Strongly Agree" to "Strongly Disagree") regarding three subscales (Parental Distress, Parent-Child Dysfunctional Interaction, and Difficult Child), a Defensive Responding Scale, and Total Score. Both tools will be administered on Day 2 (Orientation) and Day 15 (Closure) for both intervention and control groups. The outcome for APQ-Pr and PSI-SF is a change from baseline levels between the two groups after adjusting for baseline measurements. PSI-SF instrument is freely available online. The use of the APQ-Pr instrument (Spanish Version) was authorized by Nuria de la Osa.
Parent Sense of Competence Scale (PSOC) [15 weeks]
Trained personnel will evaluate parental satisfaction, and efficacy will be measured with the Parent Sense of Competence Scale (PSOC) its two subscales are "Satisfaction", which evaluates parental frustration, anxiety, and motivation as an affective dimension while "Efficacy" evaluates competence, problem-solving ability, and parenting role capability as an instrumental dimension. PSOC is a 17-item report measure that responded to a 6-point Likert Scale (from 1 = Strongly Agree to 6 = Strongly Disagree). Nine items are reverse scaled (i.e., higher scores indicate a lower parental sense of competence). A higher score for Total Score indicates a higher parenting sense of competence. Test and retest reliability ranges from .46 to .82, and alpha levels range from .82 to .7034,35. PSOC tools will be administered on Day 2 (Orientation) and Day 15 (Closure) for both intervention and control groups.
Therapy Evaluation Scale (TES) [15 weeks]
The therapy Evaluation Scale (TES) evaluates perceived parental satisfaction with treatment, the ability to adequately apply treatment strategies at home, quality of the therapist-client relationship, and asks if the client has any suggested changes to improve the treatment. Our collaborator developed this scale for Puerto Rican families in 1997 (Matos, 1997), and it was adapted to ensure relevance to Yoga Therapy. The design of the items does not allow an analysis of psychometric properties. The TES tool will be administered on Day 15 (Closure) for both intervention and control groups. The outcome for PSOC is a change from baseline levels between two groups after adjusting for baseline measurements. PSOC is freely available online. Dr. Maribel Matos authorized the use of this TES (Spanish Version).
Heart rate variability (HRV) [15 weeks]
We will measure heart rate variability (HRV) pre- and post-intervention in both groups with the Inner Balance Bluetooth BT4.0 (BLE-Bluetooth Low energy) monitor, which works at an output power range of 0.5 milliwatts (mW) or less. HRV will be recorded as described by McCraty et al. (2009, p.23). Baseline HRV will be measured, at the beginning of each session. The monitor is placed on the child's earlobe and transmits via Bluetooth. The HeartMath quantifies heart rhythm by identifying the maximum peak in the 0.04-0.26 Hz range26. The methodology of the HeartMath is described by McCraty et al. (2009, p.23)26. HR will be measured during pre- and post-yoga therapy sessions in a randomly selected family unit; one child of a family unit per intervention day will receive HRV measurements. Dr. Esparham will be a consultant.

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Years to 6 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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