Autism Spectrum DisorderNCT05154981
Partners in School: Promoting Continuity Across Home and School
A study testing Education communication skills (ECS) training and Partners in School in people with Autism Spectrum Disorder, run by New York State Psychiatric Institute at 1 site in United States.
Trial summary
Partners in School is a collection of implementation strategies (e.g., communication training, problem-solving consultation) to help parents/primary caregivers and teachers of children with autism spectrum disorder implement the same practices across home and school. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Education communication skills (ECS) training and Partners in School
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2022to 18 Aug 2024
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must be parent/primary caregiver or full-time, lead teacher
- Must have or teach preschool, pre- kindergarten, kindergarten, or 1st grade child with ASD
- Must have or teach child with ASD that can see and hear
- Access to internet via wifi-enabled phone, tablet, or computer
- Must be English or Spanish speaking
- An active email -
Who cannot join
- Parents with younger (less than preschool) or older children (in 2nd grade or above)
- Teachers who teach older than 1st grade.
- Teaching assistants
Trial locations and contacts
1 site in 1 country.
United States1 site
Research Foundation for Mental Hygiene at the New York State Psychiatric Institute
New York, New York, 10032-1007
About this study
Official title: Partners in School: Promoting Continuity Across Home and School for Children with Autism by Improving Parent-Teacher Communication During the Transition to School
Partners in School is a collection of implementation strategies (e.g., communication training, problem-solving consultation) to help parents/primary caregivers and teachers of children with autism spectrum disorder implement the same practices across home and school.
Read the detailed description
We recruited a total of 48 participants (N=22 parent-teacher dyads) from urban and suburban public schools in New York, New Jersey, and Connecticut. Teachers were matched on years of teaching experience (0-2 years, 3-5 years, 5-10 years, or 11+ years), and then randomized to the experimental condition or the control condition. The experimental condition had 13 parent-teacher dyads (N=26 participants) and the control condition had 11 parent-teacher dyads (N=22 participants). The experimental condition included the five steps of Partners in School including the pre-consultation phone interview, web-based communication skills training for the parent or teacher through School Talk, in-person parent-teacher conference, three weeks of implementing the same intervention with the student at home (by parents) and school (by the teacher), and a post-consultation phone interview. Parents and teachers also completed surveys at the beginning and end of Partners in School. The control condition had the same experiences but the parents/teachers in that condition did not receive communication skills training through School Talk. One of the key outcomes is that recruitment, randomization, condition protocols, retention, and assessment of Partners in School with School Talk is feasible and acceptable. These findings are significant to the scientific field because they suggest that researchers can partner with public schools and train parents and teachers to communicate and collaborate effectively in order to double the dosage, intensity, and impact of evidenced-based practices for young children on the autism spectrum disorder (ASD).
- Conditions
- Autism Spectrum Disorder
- Being tested
- Education communication skills (ECS) training, Partners in School
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education communication skills (ECS) trainingBehavioural
Education communication skills (ECS) training videos were developed from LEAPS (Listen, Educate, Assess, Partner and Support), a set of 10- to 20- sec videos that help patients and physicians communicate health concerns and treatment plans to each other. ECS training videos target parent-teacher communication during the transition to school for children with autism.
Partners in SchoolBehavioural
Partners in School is a problem-solving consultation that encourages parents and teachers to implement the same evidence-based interventions across home and school
| Study group | Role | What they receive |
|---|---|---|
| Partners in School with Education Communication Skills (ECS) Training | Experimental | Parents and teachers in the experimental condition will receive Partners in School with communication training. Receives: Behavioral: Education communication skills (ECS) training; Behavioral: Partners in School |
| Partners in School without Education Communication Skills (ECS) Training | Active comparator | Parents and teachers in the control condition will receive Partners in School without communication training. Receives: Behavioral: Partners in School |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adapted LEAPS Questionnaire about ECS training (A-LEAPS)
The A-LEAPS will be an 18-item parent questionnaire (adapted patient form) and a 23-item teacher questionnaire (adapted physician form). At the baseline self-assessment, parents and teachers will be asked to report on their communication practices using never, sometimes, or always used. At the post-consultation self-assessment, they will be asked to again reflect on their communication practices, but this time with the specific Partners in School parent-teacher consultation meeting just completed. An example item is, "I set an agenda for the meeting so that I am sure we get to all the things I want to cover."
Measured: baseline
Adapted LEAPS Questionnaire about ECS training (A-LEAPS)
The A-LEAPS will be an 18-item parent questionnaire (adapted patient form) and a 23-item teacher questionnaire (adapted physician form). At the baseline self-assessment, parents and teachers will be asked to report on their communication practices using never, sometimes, or always used. At the post-consultation self-assessment, they will be asked to again reflect on their communication practices, but this time with the specific Partners in School parent-teacher consultation meeting just completed. An example item is, "I set an agenda for the meeting so that I am sure we get to all the things I want to cover."
Measured: at study completion, an average of 10 weeks
Parent-Teacher Relationship Scale-Second Edition (PTRS-II)
The PTRS-II is a 24-item measure that examines the degree of connection felt between parent and teacher pairs, by examining joining (affiliation and support, dependability and availability, shared expectations and beliefs, and communication from the other) and communication to the other (sharing of emotion and sharing of information). A five-point Likert scale is used from almost never to almost always. An example item is, "I don't like the way this teacher talks to me."
Measured: baseline
Parent-Teacher Relationship Scale-Second Edition (PTRS-II)
The PTRS-II is a 24-item measure that examines the degree of connection felt between parent and teacher pairs, by examining joining (affiliation and support, dependability and availability, shared expectations and beliefs, and communication from the other) and communication to the other (sharing of emotion and sharing of information). A five-point Likert scale is used from almost never to almost always. An example item is, "I don't like the way this teacher talks to me."
Measured: at study completion, an average of 10 weeks
Parent-Teacher Alliance Questionnaire (PTAQ)
The PTAQ is a 20-item measure that assesses the degree to which parents believe they have a sound working relationship with the teacher (and vice versa). A five-point Likert scale is used from strongly agree to strongly disagree. An example item is, "My child's teacher treats me as a partner in the development of my child's education plan." It was adapted from the Parenting Alliance Inventory
Measured: baseline
Parent-Teacher Alliance Questionnaire (PTAQ)
The PTAQ is a 20-item measure that assesses the degree to which parents believe they have a sound working relationship with the teacher (and vice versa). A five-point Likert scale is used from strongly agree to strongly disagree. An example item is, "My child's teacher treats me as a partner in the development of my child's education plan." It was adapted from the Parenting Alliance Inventory
Measured: at study completion, an average of 10 weeks
Participation in Problem Solving Scale (PPSS)
The PPSS asks respondents to assess their problem solving competencies using 12-items. Items are rated on a five-point Likert scale from disagree very strongly to agree very strongly. An example item is, "I gathered specific information to measure this student's progress."
Measured: baseline
Participation in Problem Solving Scale (PPSS)
The PPSS asks respondents to assess their problem solving competencies using 12-items. Items are rated on a five-point Likert scale from disagree very strongly to agree very strongly. An example item is, "I gathered specific information to measure this student's progress."
Measured: at study completion, an average of 10 weeks
Change from Baseline Fidelity (to Student Intervention Plan) at 3 weeks
Daily home-school notes will list the steps in the student intervention plan generated during the consultation meeting. Parents and teachers will indicate whether each step was completed at home or at school, respectively. The number of intervention steps completed by parents (parent fidelity) and teachers (teacher fidelity) will be computed.
Measured: daily for three weeks
Change from Baseline Alignment (of Student Intervention Plan) at 3 weeks
Daily home-school notes will list the steps in the student intervention plan generated during the consultation meeting. Parents and teachers will indicate whether each step was completed at home or at school, respectively. The number of steps in the student intervention plan completed by both parents and teachers will be used as the measure of continuity.
Measured: daily for three weeks
Secondary outcomes (10)
Frequency and Severity Form (FSF)
Using the FSF form, the consultant will ask parents and teachers to report on the top three concerns that they have for the child, as well as to rate the frequency and severity of each of those concerns. The frequency question asks, "How often does this occur with your child at school or at home?" The concern is rated on a five-point Likert scale ranging from rarely to always. The severity question asks, "How much does this impact your child's daily functioning at school or at home?" The concern is rated on a five-point Likert scale ranging from rarely to extremely. This measure was designed specifically for Partners in School.
Measured: baseline
Frequency and Severity Form (FSF)
Using the FSF form, the consultant will ask parents and teachers to report on the top three concerns that they have for the child, as well as to rate the frequency and severity of each of those concerns. The frequency question asks, "How often does this occur with your child at school or at home?" The concern is rated on a five-point Likert scale ranging from rarely to always. The severity question asks, "How much does this impact your child's daily functioning at school or at home?" The concern is rated on a five-point Likert scale ranging from rarely to extremely. This measure was designed specifically for Partners in School.
Measured: at study completion, an average of 10 weeks
Pervasive Developmental Disorder Behavior Inventory (PDDBI)
The PDDBI is an informant-based rating scale designed to assist in the assessment of children who have been diagnosed with autism. This measure has been developed to assess both problem behaviors as well as appropriate social, language, and learning/memory skills.
Measured: baseline
Pervasive Developmental Disorder Behavior Inventory (PDDBI)
The PDDBI is an informant-based rating scale designed to assist in the assessment of children who have been diagnosed with ASD. This measure has been developed to assess both problem behaviors as well as appropriate social, language, and learning/memory skills.
Measured: at study completion, an average of 10 weeks
Goal Attainment Scaling (GAS)
The home-school notes will assess the child's progress toward his/her pre-determined goal that will be formulated by parents and teachers during the consultation meeting. We will use an adapted goal attainment scaling (GAS), ranging from the situation got significantly worse (-2) to the situation got significantly better (+2).
Measured: daily for three weeks
Family-Professional Partnership Scale (FPPS)
The FPPS is an 18-item measure designed to assess the extent of parent or teacher satisfaction with their partnership orientated practices using subscales about child-focused relationships and family-focused relationships. Items are rated on a five-point Likert scale ranging from very dissatisfied to very satisfied. An example question is, "How satisfied are you that your child's teacher values your opinions about your child's needs?"
Measured: baseline
Family-Professional Partnership Scale (FPPS)
The FPPS is an 18-item measure designed to assess the extent of parent or teacher satisfaction with their partnership orientated practices using subscales about child-focused relationships and family-focused relationships. Items are rated on a five-point Likert scale ranging from very dissatisfied to very satisfied. An example question is, "How satisfied are you that your child's teacher values your opinions about your child's needs?"
Measured: at study completion, an average of 10 weeks
Self-Efficacy with Communication Form (SECF)
The SECF is a five-item questionnaire designed to capture important constructs in the self-efficacy literature (e.g., competency, effectiveness, and confidence). Items are rated on a five-point Likert scale ranging from not at all to extremely. An example question is, "How confident are you at communicating with this student's parent?" Items were derived from prior studies on self-efficacy and are sensitive to changes in Partners in School.
Measured: baseline
Self-Efficacy with Communication Form (SECF)
The SECF is a five-item questionnaire designed to capture important constructs in the self-efficacy literature (e.g., competency, effectiveness, and confidence). Items are rated on a five-point Likert scale ranging from not at all to extremely. An example question is, "How confident are you at communicating with this student's parent?" Items were derived from prior studies on self-efficacy and are sensitive to changes in Partners in School.
Measured: at study completion, an average of 10 weeks
Consultant Adherence
The Partners in School objective checklists will be used to evaluate the extent to which the consultant followed the necessary components of the Partners in School protocol. The checklist has separate objectives for the pre-consultation, consultation, and post-consultation. An example objective for the pre-consultation is, "Asked about the frequency of the concern."
Measured: at study completion, an average of 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2021
- Study start15 Sep 2022
- Primary completion23 Jun 2024
- Study completion18 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Gazi Azad, New York State Psychiatric Institute
- Investigators
- Gazi Azad, PhD, Principal investigator, New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05154981
- Sponsor's protocol ID
- 8302
- Other IDs
- 5K23MH119331-04
- Status last verified
- Jun 2024
- First submitted
- 17 Nov 2021
- Last updated
- 23 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Partners in School: Promoting Continuity Across Home and School for Children with Autism by Improving Parent-Teacher Communication During the Transition to School
- ClinicalTrials.gov ID
- NCT05154981
- Acronym / sponsor ID
- 8302
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- 23 Jun 2024 (actual)
- Study completion
- 18 Aug 2024 (actual)
- First posted
- 13 Dec 2021 (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.
Partners in School is a collection of implementation strategies (e.g., communication training, problem-solving consultation) to help parents/primary caregivers and teachers of children with autism spectrum disorder implement the same practices across home and school.
Detailed description
We recruited a total of 48 participants (N=22 parent-teacher dyads) from urban and suburban public schools in New York, New Jersey, and Connecticut. Teachers were matched on years of teaching experience (0-2 years, 3-5 years, 5-10 years, or 11+ years), and then randomized to the experimental condition or the control condition. The experimental condition had 13 parent-teacher dyads (N=26 participants) and the control condition had 11 parent-teacher dyads (N=22 participants). The experimental condition included the five steps of Partners in School including the pre-consultation phone interview, web-based communication skills training for the parent or teacher through School Talk, in-person parent-teacher conference, three weeks of implementing the same intervention with the student at home (by parents) and school (by the teacher), and a post-consultation phone interview. Parents and teachers also completed surveys at the beginning and end of Partners in School. The control condition had the same experiences but the parents/teachers in that condition did not receive communication skills training through School Talk. One of the key outcomes is that recruitment, randomization, condition protocols, retention, and assessment of Partners in School with School Talk is feasible and acceptable. These findings are significant to the scientific field because they suggest that researchers can partner with public schools and train parents and teachers to communicate and collaborate effectively in order to double the dosage, intensity, and impact of evidenced-based practices for young children on the autism spectrum disorder (ASD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Partners in School with Education Communication Skills (ECS) Training | Experimental | Behavioral: Education communication skills (ECS) training, Behavioral: Partners in SchoolParents and teachers in the experimental condition will receive Partners in School with communication training. |
| Partners in School without Education Communication Skills (ECS) Training | Active comparator | Behavioral: Partners in SchoolParents and teachers in the control condition will receive Partners in School without communication training. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Must be parent/primary caregiver or full-time, lead teacher
- Must have or teach preschool, pre- kindergarten, kindergarten, or 1st grade child with ASD
- Must have or teach child with ASD that can see and hear
- Access to internet via wifi-enabled phone, tablet, or computer
- Must be English or Spanish speaking
Key exclusion criteria (3 listed)
- Parents with younger (less than preschool) or older children (in 2nd grade or above)
- Teachers who teach older than 1st grade.
- Teaching assistants
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 |
|---|---|---|
| Education communication skills (ECS) trainingEducation communication skills (ECS) training videos were developed from LEAPS (Listen, Educate, Assess, Partner and Support), a set of 10- to 20- sec videos that help patients and physicians communicate health concerns and treatment plans to each other. ECS training videos target parent-teacher communication during the transition to school for children with autism. | Behavioural | Partners in School with Education Communication Skills (ECS) Training |
| Partners in SchoolPartners in School is a problem-solving consultation that encourages parents and teachers to implement the same evidence-based interventions across home and school | Behavioural | Partners in School with Education Communication Skills (ECS) Training, Partners in School without Education Communication Skills (ECS) Training |
Primary outcome
Adapted LEAPS Questionnaire about ECS training (A-LEAPS)
Time frame: baseline
The A-LEAPS will be an 18-item parent questionnaire (adapted patient form) and a 23-item teacher questionnaire (adapted physician form). At the baseline self-assessment, parents and teachers will be asked to report on their communication practices using never, sometimes, or always used. At the post-consultation self-assessment, they will be asked to again reflect on their communication practices, but this time with the specific Partners in School parent-teacher consultation meeting just completed. An example item is, "I set an agenda for the meeting so that I am sure we get to all the things I want to cover."
Adapted LEAPS Questionnaire about ECS training (A-LEAPS)
Time frame: at study completion, an average of 10 weeks
The A-LEAPS will be an 18-item parent questionnaire (adapted patient form) and a 23-item teacher questionnaire (adapted physician form). At the baseline self-assessment, parents and teachers will be asked to report on their communication practices using never, sometimes, or always used. At the post-consultation self-assessment, they will be asked to again reflect on their communication practices, but this time with the specific Partners in School parent-teacher consultation meeting just completed. An example item is, "I set an agenda for the meeting so that I am sure we get to all the things I want to cover."
Parent-Teacher Relationship Scale-Second Edition (PTRS-II)
Time frame: baseline
The PTRS-II is a 24-item measure that examines the degree of connection felt between parent and teacher pairs, by examining joining (affiliation and support, dependability and availability, shared expectations and beliefs, and communication from the other) and communication to the other (sharing of emotion and sharing of information). A five-point Likert scale is used from almost never to almost always. An example item is, "I don't like the way this teacher talks to me."
Parent-Teacher Relationship Scale-Second Edition (PTRS-II)
Time frame: at study completion, an average of 10 weeks
The PTRS-II is a 24-item measure that examines the degree of connection felt between parent and teacher pairs, by examining joining (affiliation and support, dependability and availability, shared expectations and beliefs, and communication from the other) and communication to the other (sharing of emotion and sharing of information). A five-point Likert scale is used from almost never to almost always. An example item is, "I don't like the way this teacher talks to me."
Parent-Teacher Alliance Questionnaire (PTAQ)
Time frame: baseline
The PTAQ is a 20-item measure that assesses the degree to which parents believe they have a sound working relationship with the teacher (and vice versa). A five-point Likert scale is used from strongly agree to strongly disagree. An example item is, "My child's teacher treats me as a partner in the development of my child's education plan." It was adapted from the Parenting Alliance Inventory
Parent-Teacher Alliance Questionnaire (PTAQ)
Time frame: at study completion, an average of 10 weeks
The PTAQ is a 20-item measure that assesses the degree to which parents believe they have a sound working relationship with the teacher (and vice versa). A five-point Likert scale is used from strongly agree to strongly disagree. An example item is, "My child's teacher treats me as a partner in the development of my child's education plan." It was adapted from the Parenting Alliance Inventory
Participation in Problem Solving Scale (PPSS)
Time frame: baseline
The PPSS asks respondents to assess their problem solving competencies using 12-items. Items are rated on a five-point Likert scale from disagree very strongly to agree very strongly. An example item is, "I gathered specific information to measure this student's progress."
Participation in Problem Solving Scale (PPSS)
Time frame: at study completion, an average of 10 weeks
The PPSS asks respondents to assess their problem solving competencies using 12-items. Items are rated on a five-point Likert scale from disagree very strongly to agree very strongly. An example item is, "I gathered specific information to measure this student's progress."
Change from Baseline Fidelity (to Student Intervention Plan) at 3 weeks
Time frame: daily for three weeks
Daily home-school notes will list the steps in the student intervention plan generated during the consultation meeting. Parents and teachers will indicate whether each step was completed at home or at school, respectively. The number of intervention steps completed by parents (parent fidelity) and teachers (teacher fidelity) will be computed.
Change from Baseline Alignment (of Student Intervention Plan) at 3 weeks
Time frame: daily for three weeks
Daily home-school notes will list the steps in the student intervention plan generated during the consultation meeting. Parents and teachers will indicate whether each step was completed at home or at school, respectively. The number of steps in the student intervention plan completed by both parents and teachers will be used as the measure of continuity.
10 secondary outcomes
Frequency and Severity Form (FSF)
Time frame: baseline
Frequency and Severity Form (FSF)
Time frame: at study completion, an average of 10 weeks
Pervasive Developmental Disorder Behavior Inventory (PDDBI)
Time frame: baseline
Pervasive Developmental Disorder Behavior Inventory (PDDBI)
Time frame: at study completion, an average of 10 weeks
Goal Attainment Scaling (GAS)
Time frame: daily for three weeks
Family-Professional Partnership Scale (FPPS)
Time frame: baseline
Family-Professional Partnership Scale (FPPS)
Time frame: at study completion, an average of 10 weeks
Self-Efficacy with Communication Form (SECF)
Time frame: baseline
Self-Efficacy with Communication Form (SECF)
Time frame: at study completion, an average of 10 weeks
Consultant Adherence
Time frame: at study completion, an average of 10 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 23 Sep 2024.
- 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.
Gazi Azad, PhD principal investigator
New York State Psychiatric Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education communication skills (ECS) training and Partners in School in people with Autism Spectrum Disorder, run by New York State Psychiatric Institute at 1 site in United States.
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 6 inclusion and 3 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 23 Sep 2024. 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 United States. 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?
Adapted LEAPS Questionnaire about ECS training (A-LEAPS) (time frame: baseline). The study lists 10 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 23 Sep 2024.