What side effects are associated with this type of intervention?

Complementary and alternative therapies for neurodevelopmental disorders, such as yoga and meditation, are generally safe with minimal side effects. Some individuals may experience mild discomfort, muscle soreness, or fatigue, particularly when beginning a new physical activity. Adherence and consistency can be challenging, potentially causing frustration or stress. Overall, these therapies are well-tolerated and can provide benefits like improved focus, reduced stress, and enhanced well-being.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of neurodevelopmental disorders, such as ADHD and autism spectrum disorder. For ADHD, common FDA-approved medications include stimulants like methylphenidate and amphetamines, as well as non-stimulants like atomoxetine and guanfacine. For autism spectrum disorder, there are no medications approved to treat the core symptoms, but antipsychotics like risperidone and aripiprazole are approved to manage irritability. Complementary and alternative therapies, such as mindfulness and yoga, are being studied for their potential benefits in improving focus, reducing stress, and enhancing well-being, although they are not FDA-approved treatments.

What other types of research exist?

Promising, novel alternatives to Parent-Child Yoga for neurodevelopmental disorders include: 1) Neurofeedback, which has shown improvements in neurocognitive functioning and behavioral outcomes in children with ADHD. 2) Mindfulness-based interventions, such as the Brief Culturally Tailored Thai Mindfulness intervention, which have demonstrated reductions in anxiety and stress. 3) Meditative movement therapies like Tai Chi and Qigong, which have been effective in reducing fatigue, depression, and improving quality of life in related conditions. 4) Sensory integration therapies, which are beneficial for children with developmental and behavioral disorders, including autism.

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Parent-Child Yoga for Congenital Heart Disease

N/A

Recruiting

Research Sponsored by Anne Gallagher

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Aged 4 to 6 years old

Poor attentional skills measured with Variability score (0.5 standard deviation below norms) at the Kiddie Conners Continuous Performance Test, 2nd Edition (K-CPT2), a sensitive measure for attentional impairments. This inclusion criteria is important since yoga intervention has shown larger effects on attention in children with greater difficulties before the intervention

Must not have

Presence of severe physical handicap that would preclude the child from participating in the yoga intervention without special adaptation

Families who do not speak French or English

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 months prior to the intervention.

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if parent-child yoga sessions can help improve attention in young children with congenital heart disease. The study involves children aged 4 to 6 and their parents. Yoga is believed to help these children focus better and reduce symptoms of ADHD. Yoga has been explored as a beneficial intervention for various health conditions, including heart disorders and pain management in children with sickle cell disease.

Who is the study for?

This trial is for children aged 4 to 6 with congenital heart disease who have had heart surgery and show poor attention skills. They must not be on ADHD medication or have severe developmental delays, physical handicaps that prevent yoga, or recent structured yoga experience.

What is being tested?

The study tests if parent-child yoga can help improve attention in kids with heart defects. It's a small test run to see how well a bigger study might work, looking at things like how many families join and stick with it.

What are the potential side effects?

Since this trial involves parent-child yoga, side effects are minimal but may include typical exercise-related issues such as muscle soreness. There should be no severe side effects unless there's an underlying condition that makes yoga unsafe.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 4 and 6 years old.

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My child struggles with attention and scored low on a specific attention test.

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I have been diagnosed with coronary heart disease needing surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My child needs special adaptations to participate in yoga due to a severe physical handicap.

Select...

My family does not speak French or English.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ months prior to the intervention.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~months prior to the intervention.

This trial's timeline: 3 weeks for screening, Varies for treatment, and months prior to the intervention. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acceptability of the randomisation process

Adherence

Dropout and withdrawal rates

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Yoga groupExperimental Treatment1 Intervention

Participants with CHD undergoing neurodevelopmental assessments and benefiting from the 8-week yoga intervention in addition to standard of care.

Group II: Waitlist control groupActive Control1 Intervention

Participants with CHD undergoing neurodevelopmental assessments at the same time as the yoga group participants and benefiting from standard of care only during the 8 weeks of the intervention. The yoga intervention will be made available to all waitlist control group participants once their trial wave is completed.

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Neurodevelopmental Disorders, such as behavioral interventions, sensory integration therapies, and mind-body practices like yoga and mindfulness, work through mechanisms that improve focus, reduce stress, and enhance overall well-being. Behavioral interventions reinforce positive behaviors and reduce negative ones through structured activities and rewards. Sensory integration therapies help children process sensory information more effectively, improving attention and reducing anxiety. Mind-body practices like yoga and mindfulness reduce stress and improve emotional regulation through physical activity and mental focus. These mechanisms are crucial as they address core symptoms such as attention deficits, anxiety, and social skills deficits, ultimately improving the quality of life for patients with Neurodevelopmental Disorders.

Basic science and treatment innovation.Effects of multisensory yoga on behavior in a male child with Apert and Asperger syndrome.