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Completed

NCT Number: NCT03636399

Group Based Treatment for Persons With Social Communication Difficulties

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.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sunnaas rehabilitation hospital

Nesoddtangen, 1450, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: 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.

Other names: GIST

Primary outcomes

  1. La Trobe Questionnaire.

    Time frame: Change from baseline up to 6 months

    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 outcomes

  1. Profile of Pragmatic Impairment in Communication (PPIC)

    Time frame: Change from baseline up to 6 months

    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.

  2. Mind in the eyes test

    Time frame: Change from baseline up to 6 months

    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).

  3. Goal Attainment Scaling (GAS)

    Time frame: Change from baseline up to 6 months

    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.

  4. Behavior Rating Inventory for Executive Functions (BRIEF)

    Time frame: Change from baseline up to 6 months

    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.

  5. Social competence checklist

    Time frame: Change from baseline up to 6 months

    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.

  6. CIQ (Community Integration Questionnaire)

    Time frame: Change from baseline up to 6 months

    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.

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

    Time frame: Change from baseline up to 6 months

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

  8. Norwegian Quality of Life Scale (PQoL),

    Time frame: Change from baseline up to 6 months

    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.

  9. Symptom Checklist (SCL-10)

    Time frame: Change from baseline up to 6 months

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

  10. Social Communication Questionnaire with additional questions (SCQ-A)

    Time frame: Change from baseline up to 6 months

    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

Sponsors and collaborators

Lead sponsor

Sunnaas Rehabilitation Hospital

Other

Collaborators

  • University of Oslo

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Aug 17, 2018
Registry last updated
Aug 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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