Advances in Treatment: Examining the Effectiveness of a Behavioral Intervention.

Study Overview
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Brief Summary
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The purpose of this research is to investigate the influence a mindfulness based cognitive therapy (MBCT) intervention will have on internalizing and externalizing problems in children and adolescents that have suffered a Traumatic Brain Injury (TBI). MBCT is a manualized intervention developed to increase social-emotional resiliency through mindful attention. Internalizing problems refer to a set of symptoms in which a person over-controls their emotions and results in social withdrawal, feelings of worthlessness, depression, and anxiety (Bloom et al., 2001). In contrast, externalizing problems refer to an under-control of emotions which results in conduct problems, impulsive behavior, and aggression. Social and emotional difficulties are prominent consequences of childhood TBI. Left untreated or undertreated, these problems often persist into adulthood, producing a wide range of challenges adapting in personal and vocational domains. At present, there are minimal non-pharmacological therapeutic approaches that effectively treat psychosocial deficits unique to TBI. Developing innovative, evidence based methods is essential in helping children recover from the injury.

Detailed Description
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Traumatic Brain Injury (TBI) represents a significant, adverse life event. Among the estimated 634,000 pediatric TBI cases occurring annually in the United States (Langlois, Rutlan-Brown, & Thomas, 2006), some reports suggest that approximately 50% of these children and adolescents will develop emotional and behavioral problems. For example, pediatric TBI is associated with negative psychosocial health outcomes including symptoms of internalizing such as depression, (Bloom et al., 2001; Fann, Hart, & Schomer, 2009), withdrawal, and anxiety, and symptoms of externalizing such as impulsivity and aggression (Iversion, 2005; Cole et al., 2008). These maladaptive symptoms are typically correlated with problems in interpersonal relationships and overall social adjustment, contributing to further detriment to social and emotional development (Ganesalingam et al., 2011). Despite these statistics, our understanding of how to best treat problematic psychosocial sequelae that follow pediatric TBI is largely uncertain and remains an understudied area in the literature. Indeed, relatively few empirically rigorous studies have been conducted examining effective treatment methods targeting internalizing and externalizing symptoms among youth with a TBI; yet, this is an essential area of study that needs to be a priority in research efforts (Semrud-Clikeman, 2010). Given the beneficial outcomes found with other pediatric populations, it is expected that the MBCT intervention would have a similar, positive impact on adjustment among children and adolescents post TBI. Problems in impulsivity, emotional lability, and anxiety are experienced by many children and adolescents with a TBI, suggesting that a MBCT intervention, which focuses on improving attention, regulatory processes, and reducing stress, would be particularly advantageous for this population. Youth that meet the inclusion / exclusion criteria will be randomly assigned to either the control group (arts and crafts activities group) or the MBCT experimental condition. The treatments will be 75 minute, weekly sessions for 8 weeks.

Official Title
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Advances in Treatment: Examining the Effectiveness of a Behavioral Intervention.

Conditions
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Psychosocial Problems

Intervention / Treatment
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* Behavioral: Mindfulness Based Cognitive Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Moderate or severe Traumatic Brain Injury (TBI) TBI occurred at least 6 months prior Age at enrollment: 9 to 17 years. Elevated internalizing or externalizing symptoms Exclusion Criteria: Substantial impairment in language ability

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants are randomly assigned to either the experimental condition or the active control condition.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness Based Cognitive Therapy<br>In the experimental condition, participants will receive 12 sessions including the instruction of mindfulness skills and cognitive behavioral therapy. | Behavioral: Mindfulness Based Cognitive Therapy<br>* The Mindfulness Based Cognitive Therapy (MBCT) intervention promotes self-regulation of emotions and behaviors within an accepting and non-judgmental therapeutic environment. During this interactive, multisensory program, participants will learn strategies to help manage their emotions and thoughts and help them to develop greater insight into the influence these experiences have on their behaviors. Participants will engage in brief at home exercises to enhance their learning of these new skills.<br>|
| No Intervention: Psychoeducation on brain injury and treatment<br>In the control condition, participants will receive 12 sessions on the psychoeducation of brain injuries, outcomes, treatment, and support. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Internalizing Symptoms | We will examine the extent to which participants that have completed the experimental condition demonstrate a decrease in Internalizing symptoms (i.e., over-controlling emotions resulting in symptoms of depression and anxiety). | 8 weeks | 
| Externalizing Symptoms | We will examine the extent to which participants that have completed the experimental condition demonstrate a decrease in Externalizing symptoms (i.e., under-controlling emotions resulting in symptoms of impulsivity, hyperactivity, and aggression). | 8 weeks | 
| Adaptive Functioning | We will examine the extent to which participants that have completed the experimental condition demonstrate an increase in adaptive functioning (i.e., resilience, social skills, leadership, activities of daily living, and functional communication). | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Attention | We will examine the extent to which participants that have completed the experimental condition demonstrate a decrease in attention problems. | 8 weeks |