Behavior DisturbanceMT-MSENCT02120820
Effect of Massage Therapy in a Multisensory Environment for Intellectual Disabilities
A study testing Multisensory environment (MSE), Massage therapy (MT) and Massage therapy in multisensory environment (MT-MSE) in people with Behavior Disturbance and Muscle Hypotonia, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
The aim of this study is to evaluate the effectiveness of multisensory environment (MSE) and/or massage therapy (MT) in residents with severe and profound intellectual disabilities (ID) who received massage therapy in MSE, activities in MSE alone, massage therapy in usual care environment, or usual care with… Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Behavior Disturbance, Muscle Hypotonia
- What is being tested?
- Multisensory environment (MSE), Massage therapy (MT) and Massage therapy in multisensory environment (MT-MSE)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteHong Kong
- Study dates
- 15 Apr 2013to 31 Jul 2017
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- exhibiting at least one type of challenging behavior
- admitted at least 3 months for long-term care
- being dependent on nursing care and physical assistance in daily activities
- aged 18 to 64 years
Who cannot join
- seriously ill or completely bed-rest residents
- having infectious diseases
- frequently discharged to general hospital for acute care
- frequent home or day leave
- having pressure ulcer and/or severe contracture and deformity
- being restless and reluctant to stay in multisensory environment, or receive massage therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Evaluation of the Clinical Efficacy of Massage Therapy in a Multisensory Environment for Residents With Severe and Profound Intellectual Disabilities
The aim of this study is to evaluate the effectiveness of multisensory environment (MSE) and/or massage therapy (MT) in residents with severe and profound intellectual disabilities (ID) who received massage therapy in MSE, activities in MSE alone, massage therapy in usual care environment, or usual care with attention.
Since there has not yet been any conclusive evidence to show the clinical efficacy of MT and MSE on relaxation and reducing challenging behaviours, the following null hypotheses are suggested:
- There will not be any differences on reducing heart and respiration rates between MT-MSE, MT, MSE, and usual care only over the 10-week intervention period and a 2-week follow-up.
- There will not be any differences on adaptive behaviours and levels of alertness between MT-MSE, MT, MSE, and control group over the 10-week intervention period and a 2-week follow-up.
- There will not be any differences on frequency and severity of challenging behaviours between MT-MSE, MT, MSE, and control group over the 10-week intervention period and a 2-week follow-up.
Read the detailed description
Design:
This study adopts a mixed methods research design, in which both quantitative (i.e., randomized controlled trial design) and qualitative (exploratory) approaches will be used.
Methods:
After the study criteria are checked and met and proxy consent has been obtained, the participants will undergo a period of washout (4 weeks) from the current multisensory environment (MSE) and/or massage therapy (MT) sessions. After that, the baseline measurement of all outcome measures will be taken. All of them will then be randomly assigned to one of the four study groups, including three treatment groups, namely massage therapy in MSE (MT-MSE), MSE only and massage therapy in usual care environment (MT), and one control (routine care) group.
The effects of the three proposed interventions and routine care only groups on the study outcomes, including frequency and severity of challenging behaviour, adaptive behaviour, alertness level, and heart and respiration rate, will be compared between groups at baseline, interim (i.e., 5 weeks after the interventions started), immediately after completion of the interventions (i.e. 10 weeks after the interventions started), and 2 weeks follow up (i.e. at 12 weeks from the start of intervention, but no intervention at week 11 and 12). A pilot study will be conducted to review the feasibility and clarity of the study procedure, intervention protocols, and outcome measurements in around 30 patients with similar clinical characteristics (i.e., 8 subjects per groups) before starting the main study.
Primary outcomes of the study are frequency and severity of challenging behaviours, and the physiological signs (i.e., respiration and pulse rate). The secondary outcomes are the levels of alertness and adaptive behaviours.
Primary nurses who are responsible to formulate the individualized MSE and/or MT programs of the participants in the three treatment groups will be invited to participate a face-to-face semi-structured interview in order to explore their perceptions and opinions towards the strengths and limitations of the intervention(s) used, factors influencing the challenging behaviours of the disabled residents, and their suggested strategies in reducing their clients' challenging behaviours in their work setting.
- Conditions
- Behavior Disturbance, Muscle Hypotonia
- Being tested
- Multisensory environment (MSE), Massage therapy (MT), Control group, Massage therapy in multisensory environment (MT-MSE)
- Keywords
- massage, multisensory environment, challenging behaviours, relaxation
- Medical subject headings
- Muscle Hypotonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multisensory environment (MSE)Behavioural
Also called Sensory stimulation, Snoezelen
Participants are staying in multisensory environment (MSE only) for 30 minutes in each session, and twice per week for 10 weeks. An enabler stays with the participant throughout the session.
Massage therapy (MT)Behavioural
Also called Massage, Manual massage
A trained massage therapist provides 15 minutes massage therapy (MT) to the participants, twice a week for 10 weeks. The massage therapist acts as an enabler.
Control groupOther
Also called Placebo, no intervention
Usual residential care will be given to these participants. Only attention and social interactions from the enabler will be provided.
Massage therapy in multisensory environment (MT-MSE)Behavioural
Also called Massage, Sensory environment
Participants receive 15 minutes massage therapy while staying in multisensory environment for 30 minutes, twice a week for 10 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Multisensory environment | Active comparator | Multisensory environment (MSE): 30 minutes/session, twice a week for 10 weeks Receives: Behavioral: Multisensory environment (MSE) |
| Massage therapy | Active comparator | Massage therapy (MT): 15 minutes/session, twice a week for 10 weeks Receives: Behavioral: Massage therapy (MT) |
| Control group | Other | Control group: usual care for 10 weeks, with attention and interactions with the caregivers only. Receives: Other: Control group |
| Massage in multisensory environment | Active comparator | Participants receive 15 minutes massage therapy in multisensory environment (MT-MSE), twice a week for 10 weeks. Receives: Behavioral: Multisensory environment (MSE); Behavioral: Massage therapy (MT); Behavioral: Massage therapy in multisensory environment (MT-MSE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavior Problem Inventory (BPI-01): frequency and severity of challenging behaviours
BPI-01 consists of 49 items with three subscales and has been widely employed in people with intellectual disability who are living in residential settings. This instrument is to evaluate the frequency and severity of challenging behaviours over the past two weeks of each assessment time points.
Each item of the scale can be assessed on both frequency and severity of each kind of behaviour. The frequency scale is a 5-point rating scale: 0 - never, 1 - monthly, 2 - weekly, 3 - daily, and 4 - hourly. The severity scale is a 4-point Likert scale, denoted by: 0 - no problem, 1 - a slight problem, 2 - a moderate problem, and 3 - a severe problem. If a resident does not exhibit any behaviour listed in the item, "never" and "no problem" should be rated on that item.
Measured: Baseline (at recruitment)
Behavior Problem Inventory (BPI-01)
Behavior Problem Inventory (as described above) will be used to measure the frequency and severity of challenging behaviours by the end of week 5.
Measured: 5 weeks after intervention started (interim assessment)
Behavior Problem Inventory (BPI-01)
Behavior Problem Inventory (BPI-01) (as described above) will be used to measure the frequency and severity of challenging behaviours by the end of week 10.
Measured: 10 weeks after intervention started (Post-test 1)
Behavior Problem Inventory (BPI-01)
Behavior Problem Inventory (as described above) will be used to measure the frequency and severity of challenging behaviours by the end of week 12.
Measured: 12 weeks after intervention started (Post-test 2)
Respiration and Pulse Rate
Relaxation is a state of parasympathetic activation by vagal nerve, and suppressing the activity of sympathetic nervous system. If massage therapy and/or MSE indicate relaxation effect, the physiological parameters, i.e. pulse and respiration rates, are expected to drop to a lower level as compared with baseline readings after the interventions.
Respiration rate and heart (pulse) rate will be measured 3 minutes just after the participants attended the intervention sessions. Their average values will be used for outcome analysis.
Measured: Baseline (at recruitment)
Respiration and Pulse Rate
Respiration rate and heart (pulse) rate will be measured 3 minutes just after the participants attended the intervention sessions by the end of week 5. Their average values will be used for outcome analysis.
Measured: 5 weeks after intervention started (interim assessment)
Respiration and Pulse Rate
Respiration rate and heart (pulse) rate will be measured 3 minutes just after the participants attended the intervention sessions by the end of week 10. Their average values will be used for outcome analysis.
Measured: 10 weeks after intervention started (Post-test 1)
Respiration and Pulse Rate
Respiration rate and heart (pulse) rate will be measured 3 minutes by the end of week 12. Their average values will be used for outcome analysis.
Measured: 12 weeks after intervention started (Post-test 2)
Secondary outcomes (8)
Alertness Observation Checklist (AOC)
With the Alertness Observation Checklist (AOC), four levels of alertness of the participants can be distinguished: active, inactive and withdrawn, sleeping or drowsy, and agitated and discontented. Each level will be assigned with a color for presentation, including green for active level, orange for inactive and withdrawn state, red for sleepy or drowsy state, and blue for an agitated and discontented state. Frequency of alertness levels will be observed during the interventions. The averaged frequency is used for outcome analysis.
Measured: Baseline (At recruitment)
Alertness Observation Checklist (AOC)
Alertness Observation Checklist (AOC) will be used to measure the average amount of the four levels of alertness by the end of week 5.
Measured: 5 weeks after intervention started (interim assessment)
Alertness Observation Checklist (AOC)
Alertness Observation Checklist (AOC) will be used to measure the average amount of the four levels of alertness by the end of week 10.
Measured: 10 weeks after intervention started (Post-test 1)
Alertness Observation Checklist (AOC)
Alertness Observation Checklist (AOC) will be used to measure the average amount of the four levels of alertness by the end of week 12.
Measured: 12 weeks after intervention started (Post-test 2)
Behaviour Checklist (BC)
The Behaviour Checklist (BC) was developed by Shapiro et al. (1997) to assess the behavioral reactions toward multi-sensory environment and relevant psychological interventions. It consists of 22 items in which 16 items are for self-stimulating behaviours and 6 items for adaptive behaviours. Frequency of each of the listed behaviors in the checklist will be observed and counted at 1-minute intervals during the intervention sessions.
Measured: Baseline (at recruitment)
Behaviour Checklist (BC)
Behaviour Checklist (BC) will be used to measure the frequency of self-stimulating and adaptive behaviours by the end of week 5.
Measured: 5 weeks after intervention started (interim assessment)
Behaviour Checklist (BC)
Behaviour Checklist (BC) will be used to measure the frequency of self-stimulating and adaptive behaviours by the end of week 10.
Measured: 10 weeks after intervention started (Post-test 1)
Behaviour Checklist (BC)
Behaviour Checklist (BC) will be used to measure the frequency of self-stimulating and adaptive behaviours by the end of week 12.
Measured: 12 weeks after intervention started (Post-test 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2014 (estimated)
- Study start15 Apr 2013
- Primary completion30 Jun 2017
- Study completion31 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Behavior DisturbanceStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wai-Tong Chien, The Hong Kong Polytechnic University
- Investigators
- Wai Tong CHIEN, PhD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02120820
- Sponsor's protocol ID
- HongKongPU
- Acronym
- MT-MSE
- Status last verified
- Aug 2017
- First submitted
- 16 Apr 2014
- Last updated
- 10 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chan JSL, Chien WT. A randomised controlled trial on evaluation of the clinical efficacy of massage therapy in a multisensory environment for residents with severe and profound intellectual disabilities: a pilot study. J Intellect Disabil Res. 2017 Jun;61(6):532-548. doi: 10.1111/jir.12377. Epub 2017 Apr 7.
PubMed 28387017
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of the Clinical Efficacy of Massage Therapy in a Multisensory Environment for Residents With Severe and Profound Intellectual Disabilities
- ClinicalTrials.gov ID
- NCT02120820
- Acronym / sponsor ID
- MT-MSE / HongKongPU
- Conditions
- Behavior Disturbance, Muscle Hypotonia
- Keywords
- massage, multisensory environment, challenging behaviours, relaxation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 15 Apr 2013 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 31 Jul 2017 (actual)
- First posted
- 23 Apr 2014 (estimated)
- 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.
The aim of this study is to evaluate the effectiveness of multisensory environment (MSE) and/or massage therapy (MT) in residents with severe and profound intellectual disabilities (ID) who received massage therapy in MSE, activities in MSE alone, massage therapy in usual care environment, or usual care with attention.
Since there has not yet been any conclusive evidence to show the clinical efficacy of MT and MSE on relaxation and reducing challenging behaviours, the following null hypotheses are suggested:
- There will not be any differences on reducing heart and respiration rates between MT-MSE, MT, MSE, and usual care only over the 10-week intervention period and a 2-week follow-up.
- There will not be any differences on adaptive behaviours and levels of alertness between MT-MSE, MT, MSE, and control group over the 10-week intervention period and a 2-week follow-up.
- There will not be any differences on frequency and severity of challenging behaviours between MT-MSE, MT, MSE, and control group over the 10-week intervention period and a 2-week follow-up.
Detailed description
Design:
This study adopts a mixed methods research design, in which both quantitative (i.e., randomized controlled trial design) and qualitative (exploratory) approaches will be used.
Methods:
After the study criteria are checked and met and proxy consent has been obtained, the participants will undergo a period of washout (4 weeks) from the current multisensory environment (MSE) and/or massage therapy (MT) sessions. After that, the baseline measurement of all outcome measures will be taken. All of them will then be randomly assigned to one of the four study groups, including three treatment groups, namely massage therapy in MSE (MT-MSE), MSE only and massage therapy in usual care environment (MT), and one control (routine care) group.
The effects of the three proposed interventions and routine care only groups on the study outcomes, including frequency and severity of challenging behaviour, adaptive behaviour, alertness level, and heart and respiration rate, will be compared between groups at baseline, interim (i.e., 5 weeks after the interventions started), immediately after completion of the interventions (i.e. 10 weeks after the interventions started), and 2 weeks follow up (i.e. at 12 weeks from the start of intervention, but no intervention at week 11 and 12). A pilot study will be conducted to review the feasibility and clarity of the study procedure, intervention protocols, and outcome measurements in around 30 patients with similar clinical characteristics (i.e., 8 subjects per groups) before starting the main study.
Primary outcomes of the study are frequency and severity of challenging behaviours, and the physiological signs (i.e., respiration and pulse rate). The secondary outcomes are the levels of alertness and adaptive behaviours.
Primary nurses who are responsible to formulate the individualized MSE and/or MT programs of the participants in the three treatment groups will be invited to participate a face-to-face semi-structured interview in order to explore their perceptions and opinions towards the strengths and limitations of the intervention(s) used, factors influencing the challenging behaviours of the disabled residents, and their suggested strategies in reducing their clients' challenging behaviours in their work setting.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Multisensory environment | Active comparator | Behavioral: Multisensory environment (MSE)Multisensory environment (MSE): 30 minutes/session, twice a week for 10 weeks |
| Massage therapy | Active comparator | Behavioral: Massage therapy (MT)Massage therapy (MT): 15 minutes/session, twice a week for 10 weeks |
| Control group | Other | Other: Control groupControl group: usual care for 10 weeks, with attention and interactions with the caregivers only. |
| Massage in multisensory environment | Active comparator | Behavioral: Multisensory environment (MSE), Behavioral: Massage therapy (MT), Behavioral: Massage therapy in multisensory environment (MT-MSE)Participants receive 15 minutes massage therapy in multisensory environment (MT-MSE), twice a week for 10 weeks. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- exhibiting at least one type of challenging behavior
- admitted at least 3 months for long-term care
- being dependent on nursing care and physical assistance in daily activities
- aged 18 to 64 years
Key exclusion criteria (6 listed)
- seriously ill or completely bed-rest residents
- having infectious diseases
- frequently discharged to general hospital for acute care
- frequent home or day leave
- having pressure ulcer and/or severe contracture and deformity
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 |
|---|---|---|
| Multisensory environment (MSE)Also: Sensory stimulation, SnoezelenParticipants are staying in multisensory environment (MSE only) for 30 minutes in each session, and twice per week for 10 weeks. An enabler stays with the participant throughout the session. | Behavioural | Massage in multisensory environment, Multisensory environment |
| Massage therapy (MT)Also: Massage, Manual massageA trained massage therapist provides 15 minutes massage therapy (MT) to the participants, twice a week for 10 weeks. The massage therapist acts as an enabler. | Behavioural | Massage in multisensory environment, Massage therapy |
| Control groupAlso: Placebo, no interventionUsual residential care will be given to these participants. Only attention and social interactions from the enabler will be provided. | Other | Control group |
| Massage therapy in multisensory environment (MT-MSE)Also: Massage, Sensory environmentParticipants receive 15 minutes massage therapy while staying in multisensory environment for 30 minutes, twice a week for 10 weeks. | Behavioural | Massage in multisensory environment |
Primary outcome
Behavior Problem Inventory (BPI-01): frequency and severity of challenging behaviours
Time frame: Baseline (at recruitment)
BPI-01 consists of 49 items with three subscales and has been widely employed in people with intellectual disability who are living in residential settings. This instrument is to evaluate the frequency and severity of challenging behaviours over the past two weeks of each assessment time points. Each item of the scale can be assessed on both frequency and severity of each kind of behaviour. The frequency scale is a 5-point rating scale: 0 - never, 1 - monthly, 2 - weekly, 3 - daily, and 4 - hourly. The severity scale is a 4-point Likert scale, denoted by: 0 - no problem, 1 - a slight problem, 2 - a moderate problem, and 3 - a severe problem. If a resident does not exhibit any behaviour listed in the item, "never" and "no problem" should be rated on that item.
Behavior Problem Inventory (BPI-01)
Time frame: 5 weeks after intervention started (interim assessment)
Behavior Problem Inventory (as described above) will be used to measure the frequency and severity of challenging behaviours by the end of week 5.
Behavior Problem Inventory (BPI-01)
Time frame: 10 weeks after intervention started (Post-test 1)
Behavior Problem Inventory (BPI-01) (as described above) will be used to measure the frequency and severity of challenging behaviours by the end of week 10.
Behavior Problem Inventory (BPI-01)
Time frame: 12 weeks after intervention started (Post-test 2)
Behavior Problem Inventory (as described above) will be used to measure the frequency and severity of challenging behaviours by the end of week 12.
Respiration and Pulse Rate
Time frame: Baseline (at recruitment)
Relaxation is a state of parasympathetic activation by vagal nerve, and suppressing the activity of sympathetic nervous system. If massage therapy and/or MSE indicate relaxation effect, the physiological parameters, i.e. pulse and respiration rates, are expected to drop to a lower level as compared with baseline readings after the interventions. Respiration rate and heart (pulse) rate will be measured 3 minutes just after the participants attended the intervention sessions. Their average values will be used for outcome analysis.
Respiration and Pulse Rate
Time frame: 5 weeks after intervention started (interim assessment)
Respiration rate and heart (pulse) rate will be measured 3 minutes just after the participants attended the intervention sessions by the end of week 5. Their average values will be used for outcome analysis.
Respiration and Pulse Rate
Time frame: 10 weeks after intervention started (Post-test 1)
Respiration rate and heart (pulse) rate will be measured 3 minutes just after the participants attended the intervention sessions by the end of week 10. Their average values will be used for outcome analysis.
Respiration and Pulse Rate
Time frame: 12 weeks after intervention started (Post-test 2)
Respiration rate and heart (pulse) rate will be measured 3 minutes by the end of week 12. Their average values will be used for outcome analysis.
8 secondary outcomes
Alertness Observation Checklist (AOC)
Time frame: Baseline (At recruitment)
Alertness Observation Checklist (AOC)
Time frame: 5 weeks after intervention started (interim assessment)
Alertness Observation Checklist (AOC)
Time frame: 10 weeks after intervention started (Post-test 1)
Alertness Observation Checklist (AOC)
Time frame: 12 weeks after intervention started (Post-test 2)
Behaviour Checklist (BC)
Time frame: Baseline (at recruitment)
Behaviour Checklist (BC)
Time frame: 5 weeks after intervention started (interim assessment)
Behaviour Checklist (BC)
Time frame: 10 weeks after intervention started (Post-test 1)
Behaviour Checklist (BC)
Time frame: 12 weeks after intervention started (Post-test 2)
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 10 Aug 2017.
- Results publication: PubMed 28387017Chan JSL, Chien WT. A randomised controlled trial on evaluation of the clinical efficacy of massage therapy in a multisensory environment for residents with severe and profound intellectual disabilities: a pilot study. J Intellect Disabil Res. 2017 Jun;61(6):532-548. doi: 10.1111/jir.12377. Epub 2017 Apr 7.
- Individual participant dataSharing planned: No
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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.
Wai Tong CHIEN, PhD principal investigator
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multisensory environment (MSE), Massage therapy (MT) and Massage therapy in multisensory environment (MT-MSE) in people with Behavior Disturbance and Muscle Hypotonia, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
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 6 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 10 Aug 2017. 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 Hong Kong. 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?
Behavior Problem Inventory (BPI-01): frequency and severity of challenging behaviours (time frame: Baseline (at recruitment)). The study lists 8 primary outcomes in all. 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 NCT02120820, which also lists 1 linked publication.
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 10 Aug 2017.