UMIN-CTR Clinical Trial

Public title

The Effect of Occupational Therapy on a Case of Social Communication Disorder after Traumatic Brain Injury

Acronym

Occupational Therapy for Social Communication Disorder after Traumatic Brain Injury

Scientific Title

The Effect of Occupational Therapy on a Case of Social Communication Disorder after Traumatic Brain Injury -a single case experimental study-

Scientific Title:Acronym

Occupational Therapy for Traumatic Brain Injury

Region

Japan

Condition

traumatic brain injury

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

We have conducted interventions to reduce problematic behaviors during group activities conducted at a community activity support center for a woman after traumatic brain injury who presented with social communication disorders.
The object of the study is to explore whether a metacognitive enhancement program and a social skills training (SST) program can reduce problem behaviors during group activities using a single-case experimental design study.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

A total of 26 group activities routinely conducted at the center were recording on videos, and the number of problematic behaviors of the participant during group activities will be measured. We used ABAB design (withdrawal/reversal design)of single case experimental methods, A1: 6 times in the baseline phase, B1: 8 times in metacognitive enhancement program phase, A2: 8 times in the non-intervention phase, B2: 6 times in the SST intervention phase. After the baseline period, the first video analysis was already conducted to identify targeted problem behaviors. A second video analysis will be conducted to measure the number of problem behaviors by a different evaluator from the group implementer and researcher after the completion of the entire program.

Key secondary outcomes

The subject's self-perception of communication symptoms throughout the four periods assessed. Assessment performed using the Self-Regulation Skills Interview (SRSI) in Japanese before the baseline phase and on the last day of B1, A2, and B2 phases.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

75

years-old

>=

Gender

Male and Female

Key inclusion criteria

The participant with traumatic brain injury who meet all of the following criteria was eligible.
1)A person diagnosed with cognitive disorders due to brain injury.
2)A person with social communication impairment that affects daily life as a chronic symptom more than 10 years after the injury.
3)A person who is between 20 and 75 years old and present at the community activity support center where the principal investigator previously worked.
4)A person received a full explanation of their participation in this study, and showed the consent of this study based on a thorough understanding of the situation.

Key exclusion criteria

People fall into any of the following categories would not be included in this study
1) People showed maladjustment or refusal to participate in the intervention processes.
2) Others who are deemed inappropriate as research subjects by the principal investigator.

Target sample size

1

Name of lead principal investigator

1st name	Tomoko
Middle name
Last name	Miyahara

Organization

Kansai Medical University

Division name

Faculty of Rehabilitation

Zip code

573-1136

Address

Uyamahigashicho 18-89, Hirakata, Osaka, Japan

TEL

072-856-2441

Email

miyahart@makino.kmu.ac.jp

Name of contact person

1st name	Tomoko
Middle name
Last name	Miyahara

Organization

Kansai Medical University

Division name

Faculty of Rehabilitation

Zip code

573-1136

Address

Uyamahigashicho 18-89, Hirakata, Osaka, Japan

TEL

072-856-2441

Homepage URL

Email

miyahart@makino.kmu.ac.jp

Institute

Kansai Medical University

Institute

Department

Personal name

Tomoko Miyahara

Organization

Kansai Medical University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

ethics review committee of Kansai Medical University

Address

Room 701, 7th Floor, School Building, 2-5-1 Shinmachi, Hirakata City, Osaka, Japan

Tel

072-804-0101

Email

rinriirb@hirakata.kmu.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

地域活動支援センターWakaba(兵庫県）

Date of disclosure of the study information

2023

Year

04

Month

13

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

1

Results

Significant differences in the number of actions were found between periods A1 and B(TAU=-0.88,P<0.01), A1 and A2(TAU=-0.77, P=0.02), A1 and C(TAU=-0.83,P=0.02), B and A2(TAU=0.86, P<0.01), and A2 and C(TAU=-0.69, P=0.03), except between periods B and C. For the SRSI scores were 8 points before A1, 6 points after B, 6 points after A2, and 6 points after C in the "emergent awareness". Item "Strategy awareness" were 9 points before A1, 8 points after B, 8 points after A2, and 8 points after C.

Results date posted

2023

Year

07

Month

02

Day

Results Delayed

Delay expected

Results Delay Reason

The intervention was conducted by the researcher using the single-case experimental method after obtaining written consent from one subject at a community activity support center that do not have an ethics review committee. After that the researcher joined the university and would analyze the existing information after going through a new ethical review process at the university institution.

Date of the first journal publication of results

Baseline Characteristics

One woman in her 40s who suffered a head injury 16 years ago, she had gone to the community activity support center. Decreased social communication skills resulted in excessive communication with others and disinhibition symptoms. Those symptoms affected the progress of group activities.　Interventions were provided to this subject to control problematic behavior during the group.

Participant flow

A1: 6 times in the baseline phase, B1: 8 times in metacognitive enhancement program phase, A2: 8 times in the non-intervention phase, B2: 6 times in the SST intervention phase were conducted. The B2 period was scheduled to be conducted 8 times, but ended with 6 sessions because group activities were suspended due to COVID-19. The study was conducted after the subjects were given a study description and written consent prior to the start of the baseline. The intervention phases were completed.

Adverse events

Outcome measures

The number of problematic behaviors of the subjects during the group activities was conducted by the researcher and the evaluator during the A1 (baseline) period. The analysis for the B1, A2, and B2 periods will be conducted after the release of the information by the evaluator with blinding the timing of the video records.

Plan to share IPD

There is no shared plan.

IPD sharing Plan description

There is no shared plan.

Recruitment status

Completed

Date of protocol fixation

2019

Year

01

Month

01

Day

Date of IRB

2023

Year

02

Month

21

Day

Anticipated trial start date

2019

Year

04

Month

08

Day

Last follow-up date

2020

Year

03

Month

26

Day

Date of closure to data entry

2023

Year

05

Month

31

Day

Date trial data considered complete

2023

Year

05

Month

31

Day

Date analysis concluded

2023

Year

05

Month

31

Day

Other related information

The intervention effect on problem behavior was examined using a single-case experimental study on one patient attending a community activity support center. The scenes were group activities usually conducted at the center, and videos were recorded to measure the number of problem behaviors of the subject. A1:6 times in the baseline phase, B1:8 times in metacognitive enhancement program phase, A2:8 times in the non-intervention phase, B2:6 times in the SST intervention phase, had already been completed.
The first video records analysis was conducted by the researcher and an evaluator to identify problem behaviors immediately after the end of the A1:baseline period. The analysis of the B1, A2, and B2 phases will be conducted after the release of the information by the evaluator with blinding the phases of the video records.
In B1:metacognitive enhancement program phase, 30 minutes of counseling was conducted before each group participation, in B2:SST phase, 30 minutes of individual SST was conducted before each group participation, in both A and B phases, subjects participated in group activities as usual. Group activities were held once a week at the center, with one coordinator conducting group discussions on brain functions, computer operation exercises, and physical exercises using rhythms.

Registered date

2023

Year

04

Month

13

Day

Last modified on

2023

Year

07

Month

02

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057934