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Oppositional Defiant Disorder in ChildrenYTODDNCT05865067

Yoga Therapy and Oppositional Defiant Disorder Behaviors

A study testing Yoga Therapy and Exercise in people with Oppositional Defiant Disorder in Children and Oppositional Defiant Disorder, run by University of Puerto Rico at 1 site in Puerto Rico.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 4 to 6 years
What is being tested?
Yoga Therapy and Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
1 sitePuerto Rico
Study dates
1 Jun 2023to 31 Dec 2023
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 4 to 6 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Karen G Martínez-González, MD, MSc contact

7877582525 ext. 1923

karen.martinez4@upr.edu

Alisha M Subervi-Vázquez contact

7873634627

alisha.subervi@upr.edu

Puerto Rico1 site, 1 recruiting

  • University of Puerto Rico Medical Sciences Campus

    San Juan, PR, 00926

    Alisha M Subervi-Vázquez, MD, MSc, MPH, 7873634627, alisha.subervi@upr.edu

    Karen G Martínez, MD, MSc, 7877582525 ext. 1923, alisha.subervi@upr.edu

    Recruiting

Other trials in Puerto Rico

About this study

Official title: Yoga Therapy for Latino Preschool Children With Oppositional Defiant Behaviors

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:

Read more
  • 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.

Read the 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.

Being tested
Yoga Therapy, Exercise
Keywords
yoga, yoga therapy, preschool, odd, oppositional defiant disorder, latino, children
Medical subject headings
Oppositional Defiant Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Yoga TherapyOther

    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.

  • ExerciseOther

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

Study groups in NCT05865067
Study groupRoleWhat they receive
Yoga TherapyExperimentalParticipation 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.
Receives: Other: Yoga Therapy
Wait-List with ExerciseActive comparatorParticipation 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.
Receives: Other: Exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 15 weeks

Secondary outcomes (5)

  1. Alabama Parenting Questionnaire Preschool Version (APQ-Pr)

    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).

    Measured: 15 weeks

  2. Parenting Stress Index, Short Form (PSI-SF)

    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.

    Measured: 15 weeks

  3. Parent Sense of Competence Scale (PSOC)

    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.

    Measured: 15 weeks

  4. Therapy Evaluation Scale (TES)

    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).

    Measured: 15 weeks

  5. Heart rate variability (HRV)

    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.

    Measured: 15 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2023
  2. Study start1 Jun 2023
  3. Primary completion31 Dec 2023 (estimated)
  4. Study completion31 Dec 2023 (estimated)

Resources

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
Randomised
Intervention model
Crossover
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.
Masking
None (open label)
Enrolment
34 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05865067
Sponsor's protocol ID
2290034907
Acronym
YTODD
Status last verified
May 2023
First submitted
9 May 2023
Last updated
4 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Stormshak EA, Bierman KL, McMahon RJ, Lengua LJ. Parenting practices and child disruptive behavior problems in early elementary school. Conduct Problems Prevention Research Group. J Clin Child Psychol. 2000 Mar;29(1):17-29. doi: 10.1207/S15374424jccp2901_3.

    PubMed 10693029

  • Canino G, Shrout PE, Rubio-Stipec M, Bird HR, Bravo M, Ramirez R, Chavez L, Alegria M, Bauermeister JJ, Hohmann A, Ribera J, Garcia P, Martinez-Taboas A. The DSM-IV rates of child and adolescent disorders in Puerto Rico: prevalence, correlates, service use, and the effects of impairment. Arch Gen Psychiatry. 2004 Jan;61(1):85-93. doi: 10.1001/archpsyc.61.1.85.

    PubMed 14706947

  • Steiner H, Remsing L; Work Group on Quality Issues. Practice parameter for the assessment and treatment of children and adolescents with oppositional defiant disorder. J Am Acad Child Adolesc Psychiatry. 2007 Jan;46(1):126-141. doi: 10.1097/01.chi.0000246060.62706.af.

    PubMed 17195736

  • Matos M, Bauermeister JJ, Bernal G. Parent-child interaction therapy for Puerto Rican preschool children with ADHD and behavior problems: a pilot efficacy study. Fam Process. 2009 Jun;48(2):232-52. doi: 10.1111/j.1545-5300.2009.01279.x.

    PubMed 19579907

  • Tyagi A, Cohen M. Yoga and heart rate variability: A comprehensive review of the literature. Int J Yoga. 2016 Jul-Dec;9(2):97-113. doi: 10.4103/0973-6131.183712.

    PubMed 27512317

  • Herbert A, Esparham A. Mind-Body Therapy for Children with Attention-Deficit/Hyperactivity Disorder. Children (Basel). 2017 Apr 25;4(5):31. doi: 10.3390/children4050031.

    PubMed 28441363

  • Schoorl J, Van Rijn S, De Wied M, Van Goozen SH, Swaab H. Variability in emotional/behavioral problems in boys with oppositional defiant disorder or conduct disorder: the role of arousal. Eur Child Adolesc Psychiatry. 2016 Aug;25(8):821-30. doi: 10.1007/s00787-015-0790-5. Epub 2015 Nov 25.

    PubMed 26608403

  • Bauermeister JJ, Puente A, Martinez JV, Cumba E, Scandar RO, Bauermeister JA. Parent perceived impact of Spaniard boys' and girls' inattention, hyperactivity, and oppositional defiant behaviors on family life. J Atten Disord. 2010 Nov;14(3):247-55. doi: 10.1177/1087054709347180. Epub 2009 Sep 18.

    PubMed 19767594

  • Harvey EA, Youngwirth SD, Thakar DA, Errazuriz PA. Predicting attention-deficit/hyperactivity disorder and oppositional defiant disorder from preschool diagnostic assessments. J Consult Clin Psychol. 2009 Apr;77(2):349-54. doi: 10.1037/a0014638.

    PubMed 19309194

  • Lahey BB, Pelham WE, Stein MA, Loney J, Trapani C, Nugent K, Kipp H, Schmidt E, Lee S, Cale M, Gold E, Hartung CM, Willcutt E, Baumann B. Validity of DSM-IV attention-deficit/hyperactivity disorder for younger children. J Am Acad Child Adolesc Psychiatry. 1998 Jul;37(7):695-702. doi: 10.1097/00004583-199807000-00008.

    PubMed 9666624

  • Loeber R, Burke JD, Lahey BB, Winters A, Zera M. Oppositional defiant and conduct disorder: a review of the past 10 years, part I. J Am Acad Child Adolesc Psychiatry. 2000 Dec;39(12):1468-84. doi: 10.1097/00004583-200012000-00007.

    PubMed 11128323

  • Canino G, Polanczyk G, Bauermeister JJ, Rohde LA, Frick PJ. Does the prevalence of CD and ODD vary across cultures? Soc Psychiatry Psychiatr Epidemiol. 2010 Jul;45(7):695-704. doi: 10.1007/s00127-010-0242-y. Epub 2010 Jun 9.

    PubMed 20532864

  • Speltz ML, McClellan J, DeKlyen M, Jones K. Preschool boys with oppositional defiant disorder: clinical presentation and diagnostic change. J Am Acad Child Adolesc Psychiatry. 1999 Jul;38(7):838-45. doi: 10.1097/00004583-199907000-00013.

    PubMed 10405501

  • Burke JD, Waldman I, Lahey BB. Predictive validity of childhood oppositional defiant disorder and conduct disorder: implications for the DSM-V. J Abnorm Psychol. 2010 Nov;119(4):739-51. doi: 10.1037/a0019708.

    PubMed 20853919

  • Jensen PS, Kenny DT. The effects of yoga on the attention and behavior of boys with Attention-Deficit/ hyperactivity Disorder (ADHD). J Atten Disord. 2004 May;7(4):205-16. doi: 10.1177/108705470400700403.

    PubMed 15487477

Questions about this trial

What is this clinical trial studying?

A study testing Yoga Therapy and Exercise in people with Oppositional Defiant Disorder in Children and Oppositional Defiant Disorder, run by University of Puerto Rico at 1 site in Puerto Rico.

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 8 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: status not confirmed, as of the sponsor's last update on 4 Oct 2023. 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 Puerto Rico. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Karen G Martínez-González, MD, MSc (7877582525 ext. 1923, karen.martinez4@upr.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disruptive Behavior Disorder Rating Scale (DBRS) (time frame: 15 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05865067, which also lists 27 linked publications.

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 4 Oct 2023.

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