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

Psychosocial Problems Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03282500
• Other study ID #: R-858-14
• Status: Recruiting
• Phase: N/A
• First received: September 12, 2017
• Last updated: September 18, 2017
• Start date: June 2015
• Est. completion date: June 2018

Study information

• Verified date: September 2017
• Source: Kessler Foundation
• Contact: Cherylynn Marino, Ph.D.
• Phone: (973) 324-8431
• Email: cmarino[@]kesslerfoundation.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 46
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Psychosocial Problems

Intervention

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.

Locations

Country	Name	City	State
United States	Kessler Foundation	East Hanover	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Kessler Foundation

Country where clinical trial is conducted

United States, 

References & Publications (7)

Bloom DR, Levin HS, Ewing-Cobbs L, Saunders AE, Song J, Fletcher JM, Kowatch RA. Lifetime and novel psychiatric disorders after pediatric traumatic brain injury. J Am Acad Child Adolesc Psychiatry. 2001 May;40(5):572-9. — View Citation

Cole WR, Gerring JP, Gray RM, Vasa RA, Salorio CF, Grados M, Christensen JR, Slomine BS. Prevalence of aggressive behaviour after severe paediatric traumatic brain injury. Brain Inj. 2008 Nov;22(12):932-9. doi: 10.1080/02699050802454808. — View Citation

Fann JR, Hart T, Schomer KG. Treatment for depression after traumatic brain injury: a systematic review. J Neurotrauma. 2009 Dec;26(12):2383-402. doi: 10.1089/neu.2009.1091. Review. — View Citation

Ganesalingam K, Yeates KO, Taylor HG, Walz NC, Stancin T, Wade S. Executive functions and social competence in young children 6 months following traumatic brain injury. Neuropsychology. 2011 Jul;25(4):466-76. doi: 10.1037/a0022768. — View Citation

Iverson GL. Outcome from mild traumatic brain injury. Curr Opin Psychiatry. 2005 May;18(3):301-17. — View Citation

Langlois J, Rutland-Brown W, Thomas K. Traumatic Brain Injury in the United States: Emergency Department Visits, Hospitalizations, and Deaths. Atlanta, GA: Centers for Disease Control and Prevention, National Center for Injury Prevention and Control, 2006.

Semrud-Clikeman M. Pediatric traumatic brain injury: rehabilitation and transition to home and school. Appl Neuropsychol. 2010 Apr;17(2):116-22. doi: 10.1080/09084281003708985. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Attention	We will examine the extent to which participants that have completed the experimental condition demonstrate a decrease in attention problems.	8 weeks