AzTrials
AzTrials

Brain InjuriesNCT03636399

Group Based Treatment for Persons With Social Communication Difficulties

A study testing Standard GIST and Intensive GIST in people with Brain Injuries, run by Sunnaas Rehabilitation Hospital at 1 site in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Brain Injuries
What is being tested?
Standard GIST and Intensive GIST
Could I receive a placebo?
No, everyone receives an active treatment
How many people
49 participants
Where
1 siteNorway
Study dates
1 Sep 2018to 16 Jun 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Norway1 site

  • Sunnaas rehabilitation hospital

    Nesoddtangen, 1450

Other trials in Norway

About this study

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

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
Being tested
Standard GIST, Intensive GIST
Keywords
adults, rehabilitation, social communication disorder, cognitive communication disorder, groups, evidence-based
Medical subject headings
Brain Injuries, Social Communication Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standard GISTBehavioural

    Also called 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 GISTBehavioural

    Also called 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.

Study groups in NCT03636399
Study groupRoleWhat they receive
Standard GISTExperimentalStandard Group Interactive Structured Treatment.
Receives: Behavioral: Standard GIST
Waitlist control/Intensive GISTOtherAfter a wait list control period of nine months the participants receive Intensive Group Interactive Structured Treatment.
Receives: Behavioral: Intensive GIST

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: Change from baseline up to 6 months

Secondary outcomes (10)

  1. 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.

    Measured: Change from baseline up to 6 months

  2. 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).

    Measured: Change from baseline up to 6 months

  3. 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.

    Measured: Change from baseline up to 6 months

  4. 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.

    Measured: Change from baseline up to 6 months

  5. 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.

    Measured: Change from baseline up to 6 months

  6. 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.

    Measured: Change from baseline up to 6 months

  7. Norwegian Version of the General Perceived Self-Efficacy Scale

    is a 20-item questionnaire that measures self-efficacy rated by a 4-point scale.

    Measured: Change from baseline up to 6 months

  8. 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.

    Measured: Change from baseline up to 6 months

  9. Symptom Checklist (SCL-10)

    To document self-reported psychological problems and symptoms of psychopathology, the Symptom Checklist 90-R was used.

    Measured: Change from baseline up to 6 months

  10. 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

    Measured: Change from baseline up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2018
  2. Study start1 Sep 2018
  3. Primary completion16 Jun 2020
  4. Study completion16 Jun 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
49 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03636399
Sponsor's protocol ID
2017/1360
Status last verified
Aug 2021
First submitted
12 Aug 2018
Last updated
19 Aug 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 31501112

  • 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.

    PubMed 36966953

Questions about this trial

What is this clinical trial studying?

A study testing Standard GIST and Intensive GIST in people with Brain Injuries, run by Sunnaas Rehabilitation Hospital at 1 site in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

La Trobe Questionnaire. (time frame: Change from baseline up to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03636399, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in