Group Based Treatment for Persons With Social Communication Difficulties

NCT03636399 | Completed

• 1 other identifier: 2017/1360
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Injuries

Keywords

adults; rehabilitation; social communication disorder; cognitive communication disorder; groups; evidence-based

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Profile of Pragmatic Impairment in Communication (PPIC)

  Change from baseline up to 6 months

• Mind in the eyes test

  Change from baseline up to 6 months

• Goal Attainment Scaling (GAS)

  Change from baseline up to 6 months

• Behavior Rating Inventory for Executive Functions (BRIEF)

  Change from baseline up to 6 months

• Social competence checklist

  Change from baseline up to 6 months

Study Arms (2)

Standard GIST

EXPERIMENTAL

Standard Group Interactive Structured Treatment.

Behavioral: Standard GIST

Waitlist control/Intensive GIST

OTHER

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

Behavioral: Intensive GIST

Interventions

Standard GIST BEHAVIORAL

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.

Also known as: GIST

Standard GIST

Intensive GIST BEHAVIORAL

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.

Also known as: GIST

Waitlist control/Intensive GIST

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sunnaas Rehabilitation Hospital: lead
• University of Oslo: collaborator

Study Sites (1)

Sunnaas rehabilitation hospital

Nesoddtangen, 1450, Norway

Location

Related Publications (2)

• 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.

  PMID: 31501112 BACKGROUND

• Ingebretsen SMH, Kirmess M, Smastuen MC, Hawley L, Newman J, Stubberud J. Rehabilitation of Social Communication Skills in Patients With Acquired Brain Injury With Intensive and Standard Group Interactive Structured Treatment: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2023 Jul;104(7):1016-1025. doi: 10.1016/j.apmr.2023.02.023. Epub 2023 Mar 24.

  PMID: 36966953 DERIVED

MeSH Terms

Conditions

Brain Injuries; Social Communication Disorder

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Communication Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Melanie Kirmess, PHD

  Sunnaas Sykehus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Principal Investigator

Study Record Dates

• First Submitted: August 12, 2018
• First Posted: August 17, 2018
• Study Start: September 1, 2018
• Primary Completion: June 16, 2020
• Study Completion: June 16, 2020
• Last Updated: August 19, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)