CClinicalTrials.gg
Status unknownNCT03282500Updated Sep 19, 2017

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

An interventional study of Mindfulness Based Cognitive Therapy in Psychosocial Problems, sponsored by Kessler Foundation. Status unknown at 1 site in United States. Open to participants aged 9 Years to 17 Years. Per ClinicalTrials.gov, last updated 2017-09-19.

Sponsored by Kessler Foundation · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
46
Allocation
Randomized
Ages
9 Years to 17 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Psychosocial Problems
03

Who can participate

Ages eligible
9 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Substantial impairment in language ability
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
46 participants (estimated)

Study arms

  • 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

  • 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.

Interventions

  • BehavioralMindfulness 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.

05

What researchers measure

Primary outcomes

  1. 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).

    Time frame: 8 weeks

  2. 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).

    Time frame: 8 weeks

  3. 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).

    Time frame: 8 weeks

Secondary outcomes

  1. Attention

    We will examine the extent to which participants that have completed the experimental condition demonstrate a decrease in attention problems.

    Time frame: 8 weeks

06

Study locations

1 of 1 sites recruiting
  • Kessler Foundation
    East Hanover, New Jersey 07936, United States
    Recruiting
07

References and documents

Publications

  • 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. doi: 10.1097/00004583-200105000-00017. PubMed 11349702 ↗
  • 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. PubMed 19698070 ↗
  • 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. PubMed 19005885 ↗
  • 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. PubMed 21463038 ↗
  • 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. PubMed 20467952 ↗
  • Iverson GL. Outcome from mild traumatic brain injury. Curr Opin Psychiatry. 2005 May;18(3):301-17. doi: 10.1097/01.yco.0000165601.29047.ae. PubMed 16639155 ↗
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Registry details

Key details

Study ID
NCT03282500
Lead sponsor
Kessler Foundation
Responsible party
Sponsor
First posted
Sep 14, 2017
Start date
Jun 2015
Primary completion
Jun 2018 (estimated)
Completion
Jun 2018 (estimated)
Last update
Sep 19, 2017

Study contacts

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

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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