Brain InjuriesNCT03998124
Peer Intervention for Social Skills (Brain Injury)
A study testing Peer facilitator training in people with Brain Injuries, run by University College, London.
Trial summary
To investigate the effectiveness of a peer-led group intervention compared to a staff-led activity group to improve social communication skills for people with severe acquired brain injury (ABI). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Brain Injuries
- What is being tested?
- Peer facilitator training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Apr 2015to Jul 2015
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of severe traumatic brain injury (TBI) or severe ABI with similar cognitive presentation to TBI
- Minimum of 6 months post injury
- Evidence of social communication impairment as a result of injury
- Ability to tolerate group activity
Who cannot join
- Significant aphasia
- Severe depression or psychiatric disorder
- Insufficient English to converse with peer
- Profound cognitive impairment
About this study
Official title: A Peer-led Intervention for Social Communication Skills Following Brain Injury (Main Study)
To investigate the effectiveness of a peer-led group intervention compared to a staff-led activity group to improve social communication skills for people with severe acquired brain injury (ABI).
Read the detailed description
An earlier pilot study tested the feasibility of the approach and the sensitivity of existing outcome measures to changes in group social interaction (NCT02211339). Following amendments to the pilot study protocol, twelve new participants with severe ABI were recruited from a residential post-acute rehabilitation centre. An experimental parallel group design was used to compare a peer-led group intervention to a staff-led social activity group. Participants were randomised to a peer-led intervention (n=6) or a staff-led social activity group (usual care) (n=6). The groups met twice a week for 8 weeks. A peer with severe ABI was trained separately to facilitate interaction the peer-led group. The training took place in 16 individual sessions over 4 weeks. Group behaviour was measured twice at baseline, after intervention and at maintenance (4 weeks) using measures meeting reliability, validity and responsiveness criteria tested in the pilot study.
- Conditions
- Brain Injuries
- Being tested
- Peer facilitator training, Usual care
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer facilitator trainingBehavioural
Peer facilitation of a project-based activity without staff present
Usual careOther
Staff-led social activity
| Study group | Role | What they receive |
|---|---|---|
| Peer-led intervention | Experimental | Individuals met twice a week for 8 weeks and participated in a peer-mediated social communication skills group. Receives: Behavioral: Peer facilitator training |
| Staff-led social activity group | Active comparator | Individuals met twice a week for 8 weeks and participated in staff-led social activities. Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Adapted Measure of Participation in Conversation (MPC): Interaction Scale
This 9 point Likert scale is a measure of verbal and non-verbal participation in conversation. Scores range from 0 (no participation) to 4 (full participation) with half point scoring.
Measured: Baseline to maintenance (week 12)
The Adapted Measure of Participation in Conversation (MPC): Transaction Scale
This 9 point Likert scale is a measure of the ability to share and request information in conversation. Scores range from 0 (no participation) to 4 (full participation) with half point scoring.
Measured: Baseline to maintenance (week 12)
The Interactional Network Tool (INT)
A new measure of group social participation developed for this study. The INT captures group interaction patterns using communication behaviour frequencies and principles of social network analysis. The data is relational and follows a scale-free distribution.
Measured: Baseline to maintenance (week 12)
Secondary outcomes (2)
La Trobe Communication Questionnaire (self-report)
The LCQ (self) is a measure of perceived change in social communication skills. Scores range from 30 - 120. A higher score indicates perception of more impaired skills.
Measured: Baseline to maintenance (week 12)
La Trobe Communication Questionnaire (other-report)
The LCQ (other) is a measure of perceived change in social communication skills. Scores range from 30-120. A higher score indicates perception of more impaired skills.
Measured: Baseline to maintenance (week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2019
- Study startApr 2015
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain InjuriesStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Model description
- An experimental parallel group design
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Suzanne Beeke, PhD, Principal investigator, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03998124
- Sponsor's protocol ID
- 13/0477
- Status last verified
- Jun 2019
- First submitted
- 24 Jun 2019
- Last updated
- 11 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Available on request
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Peer-led Intervention for Social Communication Skills Following Brain Injury (Main Study)
- ClinicalTrials.gov ID
- NCT03998124
- Acronym / sponsor ID
- 13/0477
- Conditions
- Brain Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- Apr 2015 (actual)
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 26 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the effectiveness of a peer-led group intervention compared to a staff-led activity group to improve social communication skills for people with severe acquired brain injury (ABI).
Detailed description
An earlier pilot study tested the feasibility of the approach and the sensitivity of existing outcome measures to changes in group social interaction (NCT02211339). Following amendments to the pilot study protocol, twelve new participants with severe ABI were recruited from a residential post-acute rehabilitation centre. An experimental parallel group design was used to compare a peer-led group intervention to a staff-led social activity group. Participants were randomised to a peer-led intervention (n=6) or a staff-led social activity group (usual care) (n=6). The groups met twice a week for 8 weeks. A peer with severe ABI was trained separately to facilitate interaction the peer-led group. The training took place in 16 individual sessions over 4 weeks. Group behaviour was measured twice at baseline, after intervention and at maintenance (4 weeks) using measures meeting reliability, validity and responsiveness criteria tested in the pilot study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- An experimental parallel group design
| Arm | Type | Receives |
|---|---|---|
| Peer-led intervention | Experimental | Behavioral: Peer facilitator trainingIndividuals met twice a week for 8 weeks and participated in a peer-mediated social communication skills group. |
| Staff-led social activity group | Active comparator | Other: Usual careIndividuals met twice a week for 8 weeks and participated in staff-led social activities. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of severe traumatic brain injury (TBI) or severe ABI with similar cognitive presentation to TBI
- Minimum of 6 months post injury
- Evidence of social communication impairment as a result of injury
- Ability to tolerate group activity
Key exclusion criteria (4 listed)
- Significant aphasia
- Severe depression or psychiatric disorder
- Insufficient English to converse with peer
- Profound cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peer facilitator trainingPeer facilitation of a project-based activity without staff present | Behavioural | Peer-led intervention |
| Usual careStaff-led social activity | Other | Staff-led social activity group |
Primary outcome
The Adapted Measure of Participation in Conversation (MPC): Interaction Scale
Time frame: Baseline to maintenance (week 12)
This 9 point Likert scale is a measure of verbal and non-verbal participation in conversation. Scores range from 0 (no participation) to 4 (full participation) with half point scoring.
The Adapted Measure of Participation in Conversation (MPC): Transaction Scale
Time frame: Baseline to maintenance (week 12)
This 9 point Likert scale is a measure of the ability to share and request information in conversation. Scores range from 0 (no participation) to 4 (full participation) with half point scoring.
The Interactional Network Tool (INT)
Time frame: Baseline to maintenance (week 12)
A new measure of group social participation developed for this study. The INT captures group interaction patterns using communication behaviour frequencies and principles of social network analysis. The data is relational and follows a scale-free distribution.
2 secondary outcomes
La Trobe Communication Questionnaire (self-report)
Time frame: Baseline to maintenance (week 12)
La Trobe Communication Questionnaire (other-report)
Time frame: Baseline to maintenance (week 12)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2019.
- Individual participant dataSharing planned: Yes. Available on request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suzanne Beeke, PhD principal investigator
University College, London
Questions about this trial
What is this clinical trial studying?
A study testing Peer facilitator training in people with Brain Injuries, run by University College, London.
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 4 inclusion and 4 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 11 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
The Adapted Measure of Participation in Conversation (MPC): Interaction Scale (time frame: Baseline to maintenance (week 12)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jul 2019.