Group Based Treatment for Persons With Social Communication Difficulties

Brain Injuries Clinical Trial

Official title:

Group Based Treatment for Persons With Social Communication Difficulties: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03636399
• Other study ID #: 2017/1360
• Status: Completed
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: June 16, 2020

Study information

• Verified date: August 2021
• Source: Sunnaas Rehabilitation Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: June 16, 2020
• Est. primary completion date: June 16, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries

Intervention

Behavioral:
• Standard GIST
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.
• Intensive GIST
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.

Locations

Country	Name	City	State
Norway	Sunnaas rehabilitation hospital	Nesoddtangen

Sponsors (2)

Lead Sponsor	Collaborator
Sunnaas Rehabilitation Hospital	University of Oslo

Country where clinical trial is conducted

Norway, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Change from baseline up to 6 months
Secondary	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.	Change from baseline up to 6 months
Secondary	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).	Change from baseline up to 6 months
Secondary	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.	Change from baseline up to 6 months
Secondary	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.	Change from baseline up to 6 months
Secondary	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.	Change from baseline up to 6 months
Secondary	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.	Change from baseline up to 6 months
Secondary	Norwegian Version of the General Perceived Self-Efficacy Scale	is a 20-item questionnaire that measures self-efficacy rated by a 4-point scale.	Change from baseline up to 6 months
Secondary	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.	Change from baseline up to 6 months
Secondary	Symptom Checklist (SCL-10)	To document self-reported psychological problems and symptoms of psychopathology, the Symptom Checklist 90-R was used.	Change from baseline up to 6 months
Secondary	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	Change from baseline up to 6 months