Yoga Based Psychotherapy Group Feasibility and Efficacy Study

NCT01524172 | Completed Early Phase 1

• 1 other identifier: NA_00021817
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This preliminary study will examine the feasibility of conducting a randomized clinical trial of Yoga Based Psychotherapy (YBPG) and standard care mental health (SCMH) treatment compared to SCMH for children ages 8-12 years who have a history of neglect and maltreatment (trauma). The goal of the study is to inform the method and sample size for a larger randomized trial to study the effect of YMBT with SCMH compared to SCMH in improving child regulation of behavior, emotions, and daily functioning. Children who have experienced trauma, including sexual abuse, physical abuse, emotional abuse, exposure to community or domestic violence, parental substance abuse, mental health disorders, and incarceration are at risk to have dysregulation of mood, emotions and behavior. In addition, children exposed to neglect and trauma may have poor attachment to caregivers and poor peer relations. It is hypothesized the using YBPG as an adjunct to SCMH may improve children's regulation of emotion and behavior.

Conditions

Emotional Lability; PTSD

Keywords

child trauma exposure; mental health; yoga; mood regulation; child maltreatment

Outcome Measures

Primary Outcomes (1)

• To examine the feasibility of recruiting and conducting the proposed intervention and evaluation procedures on a cohort of children exposed to neglect and trauma and their caregivers using a randomized design.

  Acceptance rate

  8 years

Secondary Outcomes (1)

• Examine the effects of YBMT on heart rate variability, behavior, post traumatic stress disorder symptoms, and functioning.

  8 years

Study Arms (2)

Standard Mental Health Treatment

ACTIVE COMPARATOR

Trauma-informed evidence supported mental health treatment

Behavioral: Standard Mental Health Treatment

Yoga Based Psychotherapy Group

EXPERIMENTAL

Yoga Based Psychotherapy will be used as an adjunct mental health interventions

Behavioral: Yoga Based Psychotherapy Group

Interventions

Yoga Based Psychotherapy Group BEHAVIORAL

YBPG promotes self-regulation (attention span and physical and verbal expression/outbursts); self-soothing (breathing and movement techniques that physiologically calm when the child encounters stress or reminders of trauma); competency (successful social interaction, appropriate expression of needs and feelings, healthy coping with stress or crisis); self-awareness (of thoughts and feelings by first increasing awareness of the body and its sensations through yoga); self-esteem (positive self-regard, increase accomplishments and awareness that all individuals have different abilities); and safety and personal boundaries (establishing personal boundaries and respecting others' personal boundaries, differentiate safe and unsafe behaviors and situations).

Also known as: YBPG

Yoga Based Psychotherapy Group

Standard Mental Health Treatment BEHAVIORAL

Trauma and evidence informed therapy

Standard Mental Health Treatment

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children, ages 8-12 years,
• enrolled in treatment at KKFC and their caregivers will be invited to participate if the child continues to exhibit behavior dysregulation (Conners' Parent Rating Scale-Revised (S) of \> 60) following 3 months of SCMH at the KKFC.
• Children may have a history of receiving psychotropic medications or be currently taking stimulants at the time of study enrollment.

You may not qualify if:

• Children who are on psychotropic medications or medications that affect their heart rates, other than stimulants will be excluded from this preliminary study.
• Children with cardiac arrhythmias, endocrine disorders associated with heart rate irregularities or who are not able to cooperate or understand study procedures will be excluded.
• Non-English speaking children will be excluded. Children in foster care placements will be excluded.

Sponsors & Collaborators

• Hugo W. Moser Research Institute at Kennedy Krieger, Inc.: lead
• Substance Abuse and Mental Health Services Administration (SAMHSA): collaborator

Study Sites (1)

Kennedy Krieger Institute

Baltimore, Maryland, 21231, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Psychological Well-Being

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Personal Satisfaction; Behavior

Study Officials

• Harolyn ME Belcher, MD

  Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research, Family Center at Kennedy Krieger Institute

Study Record Dates

• First Submitted: January 30, 2012
• First Posted: February 1, 2012
• Study Start: January 1, 2009
• Primary Completion: August 23, 2017
• Study Completion: August 23, 2017
• Last Updated: April 9, 2018

Record last verified: 2018-04

Locations

US (1)