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Group Based Treatment for Persons With Social Communication Difficulties

Primary Purpose

Brain Injuries

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Standard GIST
Intensive GIST
Sponsored by
Sunnaas Rehabilitation Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Injuries focused on measuring adults, rehabilitation, social communication disorder, cognitive communication disorder, groups, evidence-based

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • traumatic brain injury (TBI), cerebrovascular accidents (stroke; CVA) patients with no concomitant diseases minimum 6 months post-injury
  • The patient are experiencing social communication disorders
  • The family member is experiencing the patients social communication disorders
  • The patient is motivated and expresses a desire to change communication behavior
  • One close family member is able to participate in the intervention process
  • Adequate Norwegian language proficiency to participate in the group
  • The patient experiences moderate to severe difficulties with minimum 3 aspects of communication assessed with La Trobe Questionnaire
  • The patient have insight into their communication difficulties (minimum intellectual insight) assessed with Awareness Questionnaire

Exclusion Criteria:

  • Age <18 years
  • Aphasia. Based on previous records.
  • Major psychiatric disorder or reported ongoing alcohol or substance abuse
  • Premorbid neurological disease or insult and/or comorbid neurological disease
  • Impaired basic linguistic, mnemonic, motor, or perceptual function that can interfere with the ability to engage with the training or intelligence quotient (IQ) < 85

Sites / Locations

  • Sunnaas rehabilitation hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Standard GIST

Waitlist control/Intensive GIST

Arm Description

Standard Group Interactive Structured Treatment.

After a wait list control period of nine months the participants receive Intensive Group Interactive Structured Treatment.

Outcomes

Primary Outcome Measures

La Trobe Questionnaire.
The LaTrobe Communication Questionnaire (LCQ) is a 30-item questionnaire that measures communication ability, a subjective outcome measure. Various communication behaviours are rated on a 4-point scale: 1¼never or rarely, 2¼sometimes, 3¼often and 4¼usually or always, but six items require a reverse in the scoring. Higher scores reflect reduced communications skills. The tool was developed to obtain information from various sources (e.g. self -rating by individual with TBI, rating by support person).

Secondary Outcome Measures

Profile of Pragmatic Impairment in Communication (PPIC)
PPIC is an objective measure of social communication skills designed specifically for use with people with TBI. It includes 10 feature summary scales that assess communication skills on a 6-point scale from normative (0) to very severely impaired (5), with lower scores indicating better performance. These summary scales-logical content; general participation; quantity; quality; internal relation; external relation; clarity of expression; social style; subject matter; and aesthetics.
Mind in the eyes test
This test consists of 36 black- and-white pictures of the eye region. The images are presented one by one, along with four adjectives (one target word and three foil words).
Goal Attainment Scaling (GAS)
Goal Attainment Scaling (GAS) is a flexible system of measuring outcome goals, based on a 5-point scale. Levels of goal attainment are expressed objectively in terms of concrete behaviors that can be observed and recorded.
Behavior Rating Inventory for Executive Functions (BRIEF)
BRIEF is a 75-item self and other questionnaire that measures executive functions (inhibition, shift, emotional control, self-monitoring, initiative, working memory, planning/organizing, task monitoring, organizing of materials)communication ability. Various executive behaviours are rated on a 3-point scale.
Social competence checklist
Is an interview where the participant and close family member answer 6 yes or no answers regarding the participants social communication skills. The interview is found in the GIST protocol developed by Hawley and Newman 2002.
CIQ (Community Integration Questionnaire)
The Community Integration Questionnaire (CIQ) is a community integration outcome measure developed for TBI subjects; its social integration and productivity subscales were used for this study. Frequency of such activities as shopping, leisure pursuits, visiting friends or relatives, travel, and one's work, school, or volunteer situation, are scored on a 15-item scale; a higher score indicates greater integration.
Norwegian Version of the General Perceived Self-Efficacy Scale
is a 20-item questionnaire that measures self-efficacy rated by a 4-point scale.
Norwegian Quality of Life Scale (PQoL),
is a 20-item questionnaire that measures quality of life, a subjective outcome measure. The quality of life is rated in a 0-10 point scale. Higher scores reflect high quality of life.
Symptom Checklist (SCL-10)
To document self-reported psychological problems and symptoms of psychopathology, the Symptom Checklist 90-R was used.
Social Communication Questionnaire with additional questions (SCQ-A)
SCQ-A is a 37-item questionnaire that measures communication ability, a subjective outcome measure. Various communication behaviours are rated on a 5-point scale. Higher scores reflect reduced communications

Full Information

First Posted
August 12, 2018
Last Updated
August 13, 2021
Sponsor
Sunnaas Rehabilitation Hospital
Collaborators
University of Oslo
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1. Study Identification

Unique Protocol Identification Number
NCT03636399
Brief Title
Group Based Treatment for Persons With Social Communication Difficulties
Official Title
Group Based Treatment for Persons With Social Communication Difficulties: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
June 16, 2020 (Actual)
Study Completion Date
June 16, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sunnaas Rehabilitation Hospital
Collaborators
University of Oslo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
A large proportion of patients with ABI have cognitive deficits that affect the way they communicate. Cognitive difficulties with attention, memory, executive functions and so on affect social communication. Without successful social skills, a person may engage in conflicts, become isolated and be denied access to social and vocational opportunities. Internationally, several group interventions have been developed for treating social communication difficulties during the last years. Group Interactive Structured Treatment (GIST) is a validated holistic multidisciplinary group treatment targeting social communication skills after traumatic brain injury. The main aim of the present study is to examine the efficacy of GIST for improving social communication in persons with acquired brain injury, including TBI, stroke, tumor ect. Secondary the study aims to compare the standard GIST protocol to an newly developed intensive GIST protocol. Efficacy will be assessed immediately after intervention, but also three and six months after the intervention. The project is in line with international research efforts aimed to establish more knowledge about group treatment for persons with social communication disorders after ABI.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Injuries
Keywords
adults, rehabilitation, social communication disorder, cognitive communication disorder, groups, evidence-based

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard GIST
Arm Type
Experimental
Arm Description
Standard Group Interactive Structured Treatment.
Arm Title
Waitlist control/Intensive GIST
Arm Type
Other
Arm Description
After a wait list control period of nine months the participants receive Intensive Group Interactive Structured Treatment.
Intervention Type
Behavioral
Intervention Name(s)
Standard GIST
Other Intervention Name(s)
GIST
Intervention Description
13 group modules will be administered to outpatients in 12 x 2,5-3 hours sessions. Manualized intervention; In every group session a new topic is presented, discussed and practiced in group exercises. Homework assignments between sessions.
Intervention Type
Behavioral
Intervention Name(s)
Intensive GIST
Other Intervention Name(s)
GIST
Intervention Description
13 group modules will be administered to inpatients during 4 weeks in hospital. Participants is admitted to a hospital unit for cognitive rehabilitation treating patients in acute and/or cronic phase. The participants are given extended leave every weekend to work on homework Assignments between each treatment week.
Primary Outcome Measure Information:
Title
La Trobe Questionnaire.
Description
The LaTrobe Communication Questionnaire (LCQ) is a 30-item questionnaire that measures communication ability, a subjective outcome measure. Various communication behaviours are rated on a 4-point scale: 1¼never or rarely, 2¼sometimes, 3¼often and 4¼usually or always, but six items require a reverse in the scoring. Higher scores reflect reduced communications skills. The tool was developed to obtain information from various sources (e.g. self -rating by individual with TBI, rating by support person).
Time Frame
Change from baseline up to 6 months
Secondary Outcome Measure Information:
Title
Profile of Pragmatic Impairment in Communication (PPIC)
Description
PPIC is an objective measure of social communication skills designed specifically for use with people with TBI. It includes 10 feature summary scales that assess communication skills on a 6-point scale from normative (0) to very severely impaired (5), with lower scores indicating better performance. These summary scales-logical content; general participation; quantity; quality; internal relation; external relation; clarity of expression; social style; subject matter; and aesthetics.
Time Frame
Change from baseline up to 6 months
Title
Mind in the eyes test
Description
This test consists of 36 black- and-white pictures of the eye region. The images are presented one by one, along with four adjectives (one target word and three foil words).
Time Frame
Change from baseline up to 6 months
Title
Goal Attainment Scaling (GAS)
Description
Goal Attainment Scaling (GAS) is a flexible system of measuring outcome goals, based on a 5-point scale. Levels of goal attainment are expressed objectively in terms of concrete behaviors that can be observed and recorded.
Time Frame
Change from baseline up to 6 months
Title
Behavior Rating Inventory for Executive Functions (BRIEF)
Description
BRIEF is a 75-item self and other questionnaire that measures executive functions (inhibition, shift, emotional control, self-monitoring, initiative, working memory, planning/organizing, task monitoring, organizing of materials)communication ability. Various executive behaviours are rated on a 3-point scale.
Time Frame
Change from baseline up to 6 months
Title
Social competence checklist
Description
Is an interview where the participant and close family member answer 6 yes or no answers regarding the participants social communication skills. The interview is found in the GIST protocol developed by Hawley and Newman 2002.
Time Frame
Change from baseline up to 6 months
Title
CIQ (Community Integration Questionnaire)
Description
The Community Integration Questionnaire (CIQ) is a community integration outcome measure developed for TBI subjects; its social integration and productivity subscales were used for this study. Frequency of such activities as shopping, leisure pursuits, visiting friends or relatives, travel, and one's work, school, or volunteer situation, are scored on a 15-item scale; a higher score indicates greater integration.
Time Frame
Change from baseline up to 6 months
Title
Norwegian Version of the General Perceived Self-Efficacy Scale
Description
is a 20-item questionnaire that measures self-efficacy rated by a 4-point scale.
Time Frame
Change from baseline up to 6 months
Title
Norwegian Quality of Life Scale (PQoL),
Description
is a 20-item questionnaire that measures quality of life, a subjective outcome measure. The quality of life is rated in a 0-10 point scale. Higher scores reflect high quality of life.
Time Frame
Change from baseline up to 6 months
Title
Symptom Checklist (SCL-10)
Description
To document self-reported psychological problems and symptoms of psychopathology, the Symptom Checklist 90-R was used.
Time Frame
Change from baseline up to 6 months
Title
Social Communication Questionnaire with additional questions (SCQ-A)
Description
SCQ-A is a 37-item questionnaire that measures communication ability, a subjective outcome measure. Various communication behaviours are rated on a 5-point scale. Higher scores reflect reduced communications
Time Frame
Change from baseline up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: traumatic brain injury (TBI), cerebrovascular accidents (stroke; CVA) patients with no concomitant diseases minimum 6 months post-injury The patient are experiencing social communication disorders The family member is experiencing the patients social communication disorders The patient is motivated and expresses a desire to change communication behavior One close family member is able to participate in the intervention process Adequate Norwegian language proficiency to participate in the group The patient experiences moderate to severe difficulties with minimum 3 aspects of communication assessed with La Trobe Questionnaire The patient have insight into their communication difficulties (minimum intellectual insight) assessed with Awareness Questionnaire Exclusion Criteria: Age <18 years Aphasia. Based on previous records. Major psychiatric disorder or reported ongoing alcohol or substance abuse Premorbid neurological disease or insult and/or comorbid neurological disease Impaired basic linguistic, mnemonic, motor, or perceptual function that can interfere with the ability to engage with the training or intelligence quotient (IQ) < 85
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melanie Kirmess, PHD
Organizational Affiliation
Sunnaas Sykehus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sunnaas rehabilitation hospital
City
Nesoddtangen
ZIP/Postal Code
1450
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31501112
Citation
Hansen SM, Stubberud J, Hjertstedt M, Kirmess M. Intensive and standard group-based treatment for persons with social communication difficulties after an acquired brain injury: study protocol for a randomised controlled trial. BMJ Open. 2019 Sep 8;9(9):e029392. doi: 10.1136/bmjopen-2019-029392.
Results Reference
background

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Group Based Treatment for Persons With Social Communication Difficulties

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