Advances in Treatment: Examining the Effectiveness of a Behavioral Intervention.
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|ClinicalTrials.gov Identifier: NCT03282500|
Recruitment Status : Unknown
Verified September 2017 by Kessler Foundation.
Recruitment status was: Recruiting
First Posted : September 14, 2017
Last Update Posted : September 19, 2017
|Condition or disease||Intervention/treatment||Phase|
|Psychosocial Problems||Behavioral: Mindfulness Based Cognitive Therapy||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||46 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Participants are randomly assigned to either the experimental condition or the active control condition.|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Masking Description:||The participants and outcomes assessor are blind to the assigned condition.|
|Official Title:||Advances in Treatment: Examining the Effectiveness of a Behavioral Intervention.|
|Actual Study Start Date :||June 2015|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||June 2018|
Experimental: Mindfulness Based Cognitive Therapy
In the experimental condition, participants will receive 12 sessions including the instruction of mindfulness skills and cognitive behavioral therapy.
Behavioral: Mindfulness Based Cognitive Therapy
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.
No Intervention: Psychoeducation on brain injury and treatment
In the control condition, participants will receive 12 sessions on the psychoeducation of brain injuries, outcomes, treatment, and support.
- Internalizing Symptoms [ Time Frame: 8 weeks ]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).
- Externalizing Symptoms [ Time Frame: 8 weeks ]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).
- Adaptive Functioning [ Time Frame: 8 weeks ]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).
- Attention [ Time Frame: 8 weeks ]We will examine the extent to which participants that have completed the experimental condition demonstrate a decrease in attention problems.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03282500
|Contact: Cherylynn Marino, Ph.D.||(973) firstname.lastname@example.org|
|United States, New Jersey|
|East Hanover, New Jersey, United States, 07936|
|Contact: Cherylynn Marino, Ph.D. 973-324-8431 email@example.com|