Recruiting

Behavioral Intervention

Sponsor:

Kessler Foundation

Code:

NCT03282500

Conditions

Psychosocial Problems

Eligibility Criteria

Sex: All

Age: 9 - 17

Healthy Volunteers: Not accepted

Interventions

Mindfulness Based Cognitive Therapy

Study Details

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.

Conditions

Psychosocial Problems

Study ID

NCT03282500

Start date

Jun, 2015

Status verified date

Sep, 2017

Completion date

Jun, 2018

Anticipated

Primary completion date

Jun, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 9 - 17

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

46 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

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

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.

Primary outcome measure

  • Internalizing Symptoms [ Time Frame: 8 weeks ]
  • Externalizing Symptoms [ Time Frame: 8 weeks ]
  • Adaptive Functioning [ Time Frame: 8 weeks ]

Central Contacts and Locations

Central contacts

Locations

Kessler Foundation

Recruiting

East Hanover, New Jersey, United States, 07936

Contacts

More Information

Sponsor

Kessler Foundation

Last update posted

Sep 19, 2017

Last verified

Sep, 2017

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Kessler Foundation on 2017-09-19.