Clinical trial NCT03636399: 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
Overall status: COMPLETED
Phase: NA
Conditions: Brain Injuries
Keywords: adults
rehabilitation
social communication disorder
cognitive communication disorder
groups
evidence-based
Lead sponsor: Sunnaas Rehabilitation Hospital
Sponsor class: OTHER
Collaborators: name: University of Oslo
First posted: 2018-08-17
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: La Trobe Questionnaire.
timeFrame: Change from baseline up to 6 months
Secondary outcomes:
measure: Profile of Pragmatic Impairment in Communication (PPIC)
timeFrame: Change from baseline up to 6 months
measure: Mind in the eyes test
timeFrame: Change from baseline up to 6 months
measure: Goal Attainment Scaling (GAS)
timeFrame: Change from baseline up to 6 months
measure: Behavior Rating Inventory for Executive Functions (BRIEF)
timeFrame: Change from baseline up to 6 months
measure: Social competence checklist
timeFrame: Change from baseline up to 6 months
measure: CIQ (Community Integration Questionnaire)
timeFrame: Change from baseline up to 6 months
measure: Norwegian Version of the General Perceived Self-Efficacy Scale
timeFrame: Change from baseline up to 6 months
measure: Norwegian Quality of Life Scale (PQoL),
timeFrame: Change from baseline up to 6 months
measure: Symptom Checklist (SCL-10)
timeFrame: Change from baseline up to 6 months
measure: Social Communication Questionnaire with additional questions (SCQ-A)
timeFrame: Change from baseline up to 6 months
Other outcomes:
Locations:
city: Nesoddtangen
country: Norway
facility: Sunnaas rehabilitation hospital
Study officials:
affiliation: Sunnaas Sykehus
name: Melanie Kirmess, PHD
role: PRINCIPAL_INVESTIGATOR
References:
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.