Psychosocial ProblemsNCT03282500
Advances in Treatment: Examining the Effectiveness of a Behavioral Intervention.
A study testing Mindfulness Based Cognitive Therapy in people with Psychosocial Problems, run by Kessler Foundation at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 9 to 17 years
- Conditions the study is for
- Psychosocial Problems
- What is being tested?
- Mindfulness Based Cognitive Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Substantial impairment in language ability
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Kessler Foundation
East Hanover, New Jersey, 07936
Cherylynn Marino, Ph.D., 973-324-8431, cmarino@kesslerfoundation.org
About this study
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.
- Conditions
- Psychosocial Problems
- Being tested
- Mindfulness Based Cognitive Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Based Cognitive TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Based Cognitive Therapy | Experimental | In the experimental condition, participants will receive 12 sessions including the instruction of mindfulness skills and cognitive behavioral therapy. Receives: Behavioral: Mindfulness Based Cognitive Therapy |
| Psychoeducation on brain injury and treatment | No intervention | In the control condition, participants will receive 12 sessions on the psychoeducation of brain injuries, outcomes, treatment, and support. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 8 weeks
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).
Measured: 8 weeks
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).
Measured: 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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2017
- Study startJun 2015
- Primary completionJun 2018 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Psychosocial ProblemsStudies of the same condition, open and under way.
- More trials run by Kessler FoundationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned to either the experimental condition or the active control condition.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03282500
- Sponsor's protocol ID
- R-858-14
- Status last verified
- Sep 2017
- First submitted
- 12 Sep 2017
- Last updated
- 19 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
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 11349702Fann 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 19698070Cole 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 19005885Ganesalingam 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 21463038Langlois 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 20467952Iverson 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
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advances in Treatment: Examining the Effectiveness of a Behavioral Intervention.
- ClinicalTrials.gov ID
- NCT03282500
- Acronym / sponsor ID
- R-858-14
- Conditions
- Psychosocial Problems
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Study start
- Jun 2015 (actual)
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 14 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomly assigned to either the experimental condition or the active control condition.
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Based Cognitive Therapy | Experimental | Behavioral: Mindfulness Based Cognitive TherapyIn the experimental condition, participants will receive 12 sessions including the instruction of mindfulness skills and cognitive behavioral therapy. |
| Psychoeducation on brain injury and treatment | No intervention | –In the control condition, participants will receive 12 sessions on the psychoeducation of brain injuries, outcomes, treatment, and support. |
Who may qualify
- Ages
- 9 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Substantial impairment in language ability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness Based Cognitive TherapyThe 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. | Behavioural | Mindfulness Based Cognitive Therapy |
Primary outcome
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).
1 secondary outcome
Attention
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2017.
- Background: PubMed 11349702Bloom 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.
- Background: PubMed 19698070Fann 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.
- Background: PubMed 19005885Cole 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.
- Background: PubMed 21463038Ganesalingam 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.
- BackgroundLanglois 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.
- Background: PubMed 20467952Semrud-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.
- Background: PubMed 16639155Iverson GL. Outcome from mild traumatic brain injury. Curr Opin Psychiatry. 2005 May;18(3):301-17. doi: 10.1097/01.yco.0000165601.29047.ae.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Based Cognitive Therapy in people with Psychosocial Problems, run by Kessler Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cherylynn Marino, Ph.D. ((973) 324-8431, cmarino@kesslerfoundation.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Internalizing Symptoms (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03282500, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2017.