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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
Sponsor:
Information provided by (Responsible Party):
Kessler Foundation

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Psychosocial Problems Behavioral: Mindfulness Based Cognitive Therapy Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 participants
Allocation: Randomized
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.
Primary Purpose: Treatment
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

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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).

  2. 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).

  3. 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).


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   9 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Cherylynn Marino, Ph.D. (973) 324-8431 cmarino@kesslerfoundation.org

Locations
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United States, New Jersey
Kessler Foundation Recruiting
East Hanover, New Jersey, United States, 07936
Contact: Cherylynn Marino, Ph.D.    973-324-8431    cmarino@kesslerfoundation.org   
Sponsors and Collaborators
Kessler Foundation
Publications:
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Responsible Party: Kessler Foundation
ClinicalTrials.gov Identifier: NCT03282500    
Other Study ID Numbers: R-858-14
First Posted: September 14, 2017    Key Record Dates
Last Update Posted: September 19, 2017
Last Verified: September 2017