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Treatment of Social Competence After Traumatic Brain Injury

Primary Purpose

Traumatic Brain Injury

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Group Interactive Structured Treatment
Alternative Intervention
Sponsored by
Craig Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Brain Injury focused on measuring TBI, Social Competence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Have a history of a TBI as evidenced by self report on OSU TBI ID screen
  • Sustained a TBI anytime after October 2001;
  • are at least 6 months post injury
  • score at Level 1 (Independent) or Level 2 (Overnight Supervision) on the Supervision Rating Scale;
  • are 18 years of age or older at the time of the study;
  • have adequate receptive/expressive communication skills functional for group participation, (score >5 on the Comprehension and Expression of the Functional Independence Measure (FIM)70 based on results of screening interview;
  • possess the English language skills necessary to participate in the group intervention and complete study measures;
  • demonstrate some aspect of problematic social competence by responding "yes" to at least one of 5 screening statements listed here, as reported by the participant or their support person.
  • provide Informed Consent to participate.

Exclusion Criteria:

  • are unable to verbally communicate, or require augmentative communication system;
  • are unable to attend the majority of group sessions (e.g., living at a distance from the site without consistent transportation; going on an extended vacation, planned surgeries, planning to move);
  • are currently involved in ongoing structured group psycho-social therapy;
  • are currently participating in another clinical trial.
  • are currently in one-on-one therapy with one of the therapists
  • have already participated in the GIST intervention
  • in the opinion of the PI, have any conditions which might interfere with complete of the study protocol.

Sites / Locations

  • Polytrauma Rehabilitation Center
  • Craig Hospital
  • Rehabilitation Hospital of Indiana
  • Rehabilitation Institute of Michigan
  • Hunter Holmes McGuire Medical Center
  • University of Washington

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

GIST Intervention

Alternative Intervention

Arm Description

Outcomes

Primary Outcome Measures

Change from Baseline on Profile of Pragmatic Impairment in Communication (PPIC)
This tool is designed to measure social communication impairments following TBI. It focuses not only on communication skills but also on other aspects of socially competent behavior, such as social perception and adherence to social boundaries. Videotaped conversations at the 3 time points will be evaluated using the PPIC to assess change from baseline.

Secondary Outcome Measures

Change from Baseline on LaTrobe Communication Questionnaire (LCQ)
A 30-item questionnaire that measures cognitive-communication ability, a subjective secondary outcome measure.
Change from baseline on Goal Attainment Scale
A flexible system of measuring outcome goals in individuals with TBI, based on a five-point scale. Levels of goal attainment are expressed objectively in terms of concrete behaviors that can be observed and recorded
Change from Baseline on Brief Symptom Inventory-18
Consists of 18 emotional distress items that are rated on a 5 point Likert scale and yields a Global Severity Index as well as Somatic, Anxiety, and Depressive Dimension scores.
Change from Baseline on Satisfaction with Life Scale
A subjective, 5-item scale of self-rating of global life satisfaction

Full Information

First Posted
November 1, 2011
Last Updated
July 27, 2015
Sponsor
Craig Hospital
Collaborators
Rehabilitation Hospital of Indiana, Hunter Holmes McGuire VA Medical Center, VA Palo Alto Health Care System, Wayne State University, University of Washington
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1. Study Identification

Unique Protocol Identification Number
NCT01465269
Brief Title
Treatment of Social Competence After Traumatic Brain Injury
Official Title
Treatment of Social Competence in Military Veterans, Service Members, and Civilians With Traumatic Brain Injury
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Craig Hospital
Collaborators
Rehabilitation Hospital of Indiana, Hunter Holmes McGuire VA Medical Center, VA Palo Alto Health Care System, Wayne State University, University of Washington

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study is to determine the effectiveness of holistic group treatment program (called Group Interactive Structured Treatment, or GIST) to improve social communication skills for individuals with Traumatic Brain Injury. Hypothesis: Compared to an alternative intervention, those receiving the GIST intervention will show improved social competence, improved quality of life, and stronger group cohesion.
Detailed Description
Background: Impairments in social competence are among the most prevalent sequelae after traumatic brain injury (TBI). Without successful social skills a person is often isolated, in conflict with others, and denied access to social and vocational opportunities. The aim of this study is to determine the effectiveness of a manualized group treatment program to improve and maintain social competence for individuals with TBI with identified social skill deficits. The Group Interactive Structured Treatment (GIST) - Social Competence program is a holistic, dual-disciplinary intervention targeting the pervasive interpersonal and communication problems that often interfere with participation at work, home, school and in the community after TBI. Aims and Hypotheses: Aim 1: Measure the effectiveness of the GIST intervention with multisite implementation. Hypothesis 1a: Those receiving the GIST will demonstrate significant improvement in social competence, compared to those receiving the alternative treatment, as measured by the Profile of Pragmatic Impairment in Communication (PPIC). Hypothesis 1b: Compared to the alternative intervention, those receiving the GIST will maintain improvement in social competence at 3 months post-intervention, as measured by the PPIC. Hypothesis 1c: Compared to the alternative intervention, those receiving the GIST will demonstrate improvement in additional aspects related to social competence at 3 months post-intervention, as measured by the LaTrobe Communication Questionnaire, the Goal Attainment Scale, the Brief Symptom Inventory-18, and the Post Traumatic Stress Disorder Check List - Civilian version. Hypothesis 1d: Compared to the alternative intervention, those receiving the GIST will demonstrate improvement at 3 months post intervention in quality of life, as measured by the Satisfaction with Life Scale. Aim 2: Identify the potent ingredients associated with the GIST. Hypothesis 2a: FOr participants in the GIST intervention, higher group cohesion measured by the TFI: Cohesiveness Scale will be associated with improved social competence. Hypothesis 2b: Compared to the alternative intervention, those receiving the GIST will demonstrate stronger social self efficacy associated with improved social competence, as measured by the Scale of Perceived Self Efficacy. Study Design: This study uses a two-arm, multi-centered randomized controlled clinical trial design to compare the GIST treatment to an alternative treatment, in which participants are presented information from the GIST treatment program without the group process. A total of 192 military, veteran and civilian participants with mild to moderate TBI will be enrolled by six centers. Measures will be collected at baseline, post-treatment, and 3 months post-treatment. Videotapes of participants will be evaluated for social competence by blinded independent raters, and progress on individualized social skills goals will be assessed. Replicable training of group leaders will include a 2 ½ day in-person workshop followed by feedback during a pilot of the intervention and alternative intervention. The fidelity of the intervention will be assessed by independent raters using a standardized instrument to ensure that the intervention is implemented consistently. Results of this study will be disseminated to relevant stakeholders via presentations and publications. By the end of this study, the field will have definitive evidence about the effectiveness of a group social competence intervention for people with TBI. Military Benefit: The proposed study has a high degree of relevance for returning OIF/OEF soldiers and veterans post-TBI due to the prevalence of social reintegration difficulties in this population. The GIST intervention has the potential to assist our soldiers and veterans in returning to full participation in their families, communities and productive activity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury
Keywords
TBI, Social Competence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
231 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GIST Intervention
Arm Type
Experimental
Arm Title
Alternative Intervention
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Group Interactive Structured Treatment
Intervention Description
GIST groups consist of 8 group participants and two group therapists. Group members receive the workbook and are asked to bring it to each session. During each of the 13, 1.5 hour sessions, key concepts from the previous session are reviewed, a new topic is discussed, strategies and skills are practiced interactively, and real-life social problems are addressed. Previously covered topics are integrated into each session through discussion and problem solving to provide repetition and reinforcement of information.
Intervention Type
Behavioral
Intervention Name(s)
Alternative Intervention
Intervention Description
Participants in the alternative treatment will attend 13 weekly classroom sessions, where they will view video presentations of the same curriculum topics covered in the GIST workbook. The group therapists will serve as moderators and will meet with participants individually. Group interaction will not be encouraged. Homework exercises will be offered but participants will not be asked to return their homework and will not receive any feedback.
Primary Outcome Measure Information:
Title
Change from Baseline on Profile of Pragmatic Impairment in Communication (PPIC)
Description
This tool is designed to measure social communication impairments following TBI. It focuses not only on communication skills but also on other aspects of socially competent behavior, such as social perception and adherence to social boundaries. Videotaped conversations at the 3 time points will be evaluated using the PPIC to assess change from baseline.
Time Frame
Baseline, 13 weeks (post-treatment), 25 weeks (3 mos post-treatment)
Secondary Outcome Measure Information:
Title
Change from Baseline on LaTrobe Communication Questionnaire (LCQ)
Description
A 30-item questionnaire that measures cognitive-communication ability, a subjective secondary outcome measure.
Time Frame
Baseline, 13 weeks (post-treatment), 25 weeks (3-mos post-treatment)
Title
Change from baseline on Goal Attainment Scale
Description
A flexible system of measuring outcome goals in individuals with TBI, based on a five-point scale. Levels of goal attainment are expressed objectively in terms of concrete behaviors that can be observed and recorded
Time Frame
3 weeks into intervention, 13 weeks (post-intervention), 25 weeks (3-mos post-intervention)
Title
Change from Baseline on Brief Symptom Inventory-18
Description
Consists of 18 emotional distress items that are rated on a 5 point Likert scale and yields a Global Severity Index as well as Somatic, Anxiety, and Depressive Dimension scores.
Time Frame
Baseline, 13 weeks (post treatment), 25 weeks (3 mos post-treatment)
Title
Change from Baseline on Satisfaction with Life Scale
Description
A subjective, 5-item scale of self-rating of global life satisfaction
Time Frame
Baseline, 13 weeks (post-treatment), 25 weeks (3 mos post-treatment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Have a history of a TBI as evidenced by self report on OSU TBI ID screen Sustained a TBI anytime after October 2001; are at least 6 months post injury score at Level 1 (Independent) or Level 2 (Overnight Supervision) on the Supervision Rating Scale; are 18 years of age or older at the time of the study; have adequate receptive/expressive communication skills functional for group participation, (score >5 on the Comprehension and Expression of the Functional Independence Measure (FIM)70 based on results of screening interview; possess the English language skills necessary to participate in the group intervention and complete study measures; demonstrate some aspect of problematic social competence by responding "yes" to at least one of 5 screening statements listed here, as reported by the participant or their support person. provide Informed Consent to participate. Exclusion Criteria: are unable to verbally communicate, or require augmentative communication system; are unable to attend the majority of group sessions (e.g., living at a distance from the site without consistent transportation; going on an extended vacation, planned surgeries, planning to move); are currently involved in ongoing structured group psycho-social therapy; are currently participating in another clinical trial. are currently in one-on-one therapy with one of the therapists have already participated in the GIST intervention in the opinion of the PI, have any conditions which might interfere with complete of the study protocol.
Facility Information:
Facility Name
Polytrauma Rehabilitation Center
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Craig Hospital
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
Rehabilitation Hospital of Indiana
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Rehabilitation Institute of Michigan
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Hunter Holmes McGuire Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29966645
Citation
Harrison-Felix C, Newman JK, Hawley L, Morey C, Ketchum JM, Walker WC, Bell KR, Millis SR, Braden C, Malec J, Hammond FM, Eagye CB, Howe L. Social Competence Treatment After Traumatic Brain Injury: A Multicenter, Randomized Controlled Trial of Interactive Group Treatment Versus Noninteractive Treatment. Arch Phys Med Rehabil. 2018 Nov;99(11):2131-2142. doi: 10.1016/j.apmr.2018.05.030. Epub 2018 Jun 30.
Results Reference
derived

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Treatment of Social Competence After Traumatic Brain Injury

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