Limited Participation in Daily Life ActivitiesNCT02774135
Improvement in Preschoolers' Participation as a Result of Occupational Therapy Intervention
An observational study of Limited Participation in Daily Life Activities, run by Clalit Health Services at 1 site in Israel.
Trial summary
This study evaluates the improvement of participation in everyday occupation among preschool children with mild developmental disabilities as a result of Occupational Therapy intervention. Read more about this study
- Who is it for?
- Ages 54 to 83 monthsHealthy volunteers can take part
- Conditions the study is for
- Limited Participation in Daily Life Activities
- What is being tested?
- direct occupational therapy intervention
- How many people
- 52 participants
- Where
- 1 siteIsrael
- Study dates
- 1 May 2017to 19 Apr 2021
- Phase
- Observational
- 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 54 to 83 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Kindergarten's children referred to Occuptaion Therapy
Who may be able to join
- kindergarten students of regular education
- Hebrew speaking
Who cannot join
- Students of special education
- Attending physiotherapy or psychology treatments
- Autistic Spectrum Disorder
- Cerebral Palsy
- Spina Bifida
- Developmental Intellectual Disabilities
- Blindness
- Deafness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Cohort Study to Examine the Improvement in Preschoolers' Participation as a Result of Occupational Therapy Intervention
This study evaluates the improvement of participation in everyday occupation among preschool children with mild developmental disabilities as a result of Occupational Therapy intervention.
Read the detailed description
Preschoolers suffering from mild developmental disabilities are being referred to Occupational Therapy (OT) clinics according to limitation in participating of daily occupations. As well these children often demonstrate behavior or emotional difficulties. The primary treatment goal is promoting participation yet many times the treatment focuses on child's performance skills and not on occupation based activities. Respectively its outcome measures are the child performance skills. This study will document the therapeutic intervention, and evaluate its impact on child participation as well on his performance skills and emotional aspects. Participants will be recruited from waiting list for Occupational Therapy at Clalit Health services, Child Development Institute, and will be evaluate four times. First time on referral to waiting list ( At the present time due to long waiting list, children are waiting about three to four months before starting OT intervention), second time before treatment, third time after three of treatments and last follow-up after three months.
- Being tested
- direct occupational therapy intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
direct occupational therapy interventionOther
Short term direct individual occupational therapy (9-12 weeks).Participants will receive occupational therapy intervention according to health law. The study will document the therapeutic intervention implemented in practice using the Documentation of Occupational Therapy Session during Intervention (DOTSI).
| Study group | Role | What they receive |
|---|---|---|
| direct occupational therapy intervention | group will be evaluated 4 times: on referral to waiting list for treatment, before and after 9-12 direct individual treatments of 45 minutes, and follow-up after 3 months. Receives: Other: direct occupational therapy intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of child participation
Improvement of Participation of daily occupation as measured with Child Participation Questionnaire (CPQ)
Measured: up to 12 weeks
Secondary outcomes (12)
Child performance skills
Child Performance Skills Questionnaire (PSQ)
Measured: up to 12 weeks
Child emotional aspects - Self efficacy
Pictorial scale of Perceived Competence and Social Acceptances for Young Children (PSPCSA)
Measured: up to 12 weeks
Parental aspects- Parental self efficacy
Parental Efficacy Questionnaire
Measured: up to 12 weeks
Child emotional aspects - Anxiety
Preschool Anxiety Scale (PAS)
Measured: up to 12 weeks
Child emotional aspects - Mastery motivation
Dimension of Mastery Questionnaire (DMQ18)
Measured: up to 12 weeks
Child performance skills -Fine motor precision
Bruininks-Oseretsky Test of Motor Proficiency (BOT2)
Measured: up to 12 weeks
Child performance skills - Balance
Bruininks-Oseretsky Test of Motor Proficiency (BOT2)
Measured: up to 12 weeks
Child performance skills -Executive functions
Day - Night task
Measured: up to 12 weeks
Child performance skills - Sensory profile
Short Sensory Profile (SSP2)
Measured: up to 12 weeks
Child performance skills -Core strength
Prone Extension Posture
Measured: up to 12 weeks
Child performance skills - Visual motor integration
Developmental Test of Visual-Motor Integration (VMI)
Measured: up to 12 weeks
Child performance skills - Draw a picture
Goodenough-Harris Drawing Test (DAP)
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2016 (estimated)
- Study start1 May 2017
- Primary completion31 Oct 2020
- Study completion19 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Limited Participation in Daily Life ActivitiesStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clalit Health Services
- Sponsor type
- University, hospital or other
- Collaborators
- Tel Aviv University
- Responsible party
- Principal investigator, Dr. Gary Leonard Robinson, Clalit Health Services
- Investigators
- Leonard G Robinson, Md, Principal investigator, Clalit Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02774135
- Sponsor's protocol ID
- COM150203CTIL
- Status last verified
- Apr 2021
- First submitted
- 9 May 2016
- Last updated
- 21 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Study to Examine the Improvement in Preschoolers' Participation as a Result of Occupational Therapy Intervention
- ClinicalTrials.gov ID
- NCT02774135
- Acronym / sponsor ID
- COM150203CTIL
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Clalit Health ServicesUniversity, hospital or other
- Collaborators
- Tel Aviv University
- Study start
- 1 May 2017 (actual)
- Primary completion
- 31 Oct 2020 (actual)
- Study completion
- 19 Apr 2021 (actual)
- First posted
- 17 May 2016 (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.
This study evaluates the improvement of participation in everyday occupation among preschool children with mild developmental disabilities as a result of Occupational Therapy intervention.
Detailed description
Preschoolers suffering from mild developmental disabilities are being referred to Occupational Therapy (OT) clinics according to limitation in participating of daily occupations. As well these children often demonstrate behavior or emotional difficulties. The primary treatment goal is promoting participation yet many times the treatment focuses on child's performance skills and not on occupation based activities. Respectively its outcome measures are the child performance skills. This study will document the therapeutic intervention, and evaluate its impact on child participation as well on his performance skills and emotional aspects. Participants will be recruited from waiting list for Occupational Therapy at Clalit Health services, Child Development Institute, and will be evaluate four times. First time on referral to waiting list ( At the present time due to long waiting list, children are waiting about three to four months before starting OT intervention), second time before treatment, third time after three of treatments and last follow-up after three months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| direct occupational therapy intervention | – | Other: direct occupational therapy interventiongroup will be evaluated 4 times: on referral to waiting list for treatment, before and after 9-12 direct individual treatments of 45 minutes, and follow-up after 3 months. |
Who may qualify
- Ages
- 54 to 83 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Kindergarten's children referred to Occuptaion Therapy
Key inclusion criteria (2 listed)
- kindergarten students of regular education
- Hebrew speaking
Key exclusion criteria (8 listed)
- Students of special education
- Attending physiotherapy or psychology treatments
- Autistic Spectrum Disorder
- Cerebral Palsy
- Spina Bifida
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 |
|---|---|---|
| direct occupational therapy interventionShort term direct individual occupational therapy (9-12 weeks).Participants will receive occupational therapy intervention according to health law. The study will document the therapeutic intervention implemented in practice using the Documentation of Occupational Therapy Session during Intervention (DOTSI). | Other | direct occupational therapy intervention |
Primary outcome
Improvement of child participation
Time frame: up to 12 weeks
Improvement of Participation of daily occupation as measured with Child Participation Questionnaire (CPQ)
12 secondary outcomes
Child performance skills
Time frame: up to 12 weeks
Child emotional aspects - Self efficacy
Time frame: up to 12 weeks
Parental aspects- Parental self efficacy
Time frame: up to 12 weeks
Child emotional aspects - Anxiety
Time frame: up to 12 weeks
Child emotional aspects - Mastery motivation
Time frame: up to 12 weeks
Child performance skills -Fine motor precision
Time frame: up to 12 weeks
Child performance skills - Balance
Time frame: up to 12 weeks
Child performance skills -Executive functions
Time frame: up to 12 weeks
Child performance skills - Sensory profile
Time frame: up to 12 weeks
Child performance skills -Core strength
Time frame: up to 12 weeks
Child performance skills - Visual motor integration
Time frame: up to 12 weeks
Child performance skills - Draw a picture
Time frame: up to 12 weeks
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 21 Apr 2021.
- Individual participant dataSharing planned: No
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.
Leonard G Robinson, Md principal investigator
Clalit Health Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Limited Participation in Daily Life Activities, run by Clalit Health Services at 1 site in Israel.
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 2 inclusion and 8 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 21 Apr 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 Israel. 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?
Improvement of child participation (time frame: up to 12 weeks). 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 21 Apr 2021.