Attention Deficit Hyperactivity Disorder SymptomsNCT07321327
Implementation Strategies for Caregiver and Teacher Use of Behavioral Interventions: Aim 2
A study testing Positive Behavior Management Toolkit for Caregivers and Positive Behavioral Management Toolkit for Teachers in people with Attention Deficit Hyperactivity Disorder Symptoms, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial summary
The purpose of this study is to pilot test for feasibility and initial promise an implementation strategy resource package that aims to support caregivers in using behavioral interventions for children with hyperactive, inattentive, or impulsive behaviors, when provided as an adjunct to a resource package for… Read more about this study
- Who is it for?
- Ages 4 years and olderHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder Symptoms
- What is being tested?
- Positive Behavior Management Toolkit for Caregivers and Positive Behavioral Management Toolkit for Teachers
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Feb 2026to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 4 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Teacher Inclusion criteria
- A K-5 teacher at a participating school
- Informed consent
Child Inclusion Criteria
- Is in a K-5 (ages 4-13 years) class of a participating teacher
- Nominated for participation by the participating teacher
- Identified by their participating teacher as displaying functional impairment from ADHD symptoms, as measured by a score of a 3 or greater on the modified version of the Impairment Rating Scale.
- Informed consent and assent if appropriate
Child Exclusion Criteria
- Special education classification of 'intellectual disability'
- Presents as in acute risk of harm to self or others, such that participation in the study is clinically inappropriate because the child warrants more intensive intervention
- Students from families in which there is not a caregiver who speaks English will be excluded because the focus of this study is developing an English-language version of the resource package
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19146
About this study
The purpose of this study is to pilot test for feasibility and initial promise an implementation strategy resource package that aims to support caregivers in using behavioral interventions for children with hyperactive, inattentive, or impulsive behaviors, when provided as an adjunct to a resource package for teachers. Participating children will be randomized at the classroom level to one of two conditions: a) their teacher and caregiver receive the resource package, or b) only their teacher receive the resource package. The research team will examine teacher and caregiver implementation outcomes and mental health outcomes for enrolled children.
Read the detailed description
Evidence-based interventions for children with or at-risk for Attention Deficit Hyperactivity Disorder (ADHD) include antecedent- and consequence- based behavioral interventions in both the classroom and home settings as well as effective home-school communication approaches. Schools are a promising setting in which to provide early intervention for mental health challenges and to increase access to mental health care. Furthermore, stronger integration between home- and school- based interventions has the potential to meaningfully improve child outcomes. However, there are substantial implementation challenges to caregivers' use of these evidence-based interventions. The purpose of this study is to pilot test for feasibility and initial promise an implementation strategy resource package that aims to support caregivers in using behavioral interventions for children with hyperactive, inattentive, or impulsive behaviors, when provided as an adjunct to a resource package for teachers. Participating children will be randomized at the classroom level to one of two conditions: a) both teacher and caregiver receive the resource package, or b) only the teacher receive the resource package. The research team will examine teacher and caregiver implementation outcomes and mental health outcomes for enrolled children.
- Being tested
- Positive Behavior Management Toolkit for Caregivers, Positive Behavioral Management Toolkit for Teachers
- Keywords
- Attention Deficit Hyperactivity Disorder Positive Behavior Management, Inattentive, Hyperactive, Impulsive
- Medical subject headings
- Spasm, Impulsive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive Behavior Management Toolkit for CaregiversBehavioural
Also called Implementation Strategy Resource Package for Caregivers, Supporting School Success - Caregiver Version (SSS-C)
The Positive Behavior Management Toolkit for Caregivers, or the implementation strategy resource package for caregivers, is a set of resources provided that aims to support their use of evidence-based behavior management practices and home-school communication strategies.
Positive Behavioral Management Toolkit for TeachersBehavioural
Also called Implementation Strategy Resource Package for Teachers, Supporting School Success - Teacher Version (SSS-T)
The Positive Behavior Management Toolkit for Teachers, or the implementation strategy resource package for teachers, is a set of resources provided that aims to support their use of evidence-based behavior management practices and home-school communication strategies.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Teachers in this group will receive an implementation support package and receive support in using it within their classroom management practice. Also within the intervention group (experimental), will be up to 2 students nested in the classroom and their caregivers. Caregivers in this group will receive an implementation support package and receive support in using it. Receives: Behavioral: Positive Behavior Management Toolkit for Caregivers; Behavioral: Positive Behavioral Management Toolkit for Teachers |
| Control Group | Active comparator | Teachers in this group will receive an implementation support package and receive support in using it within their classroom management practice. Also within the control group (active comparator) will be up to 2 students nested in the classroom and their caregivers. Caregivers in this group will not receive the implementation resource package. Receives: Behavioral: Positive Behavioral Management Toolkit for Teachers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Intervention Measure - Caregiver Report
Caregiver-reported total score on the Feasibility of Intervention Measure (FIM), which consists of 4 items on a 5-point Likert scale (from 1 = Completely Disagree to 5 = Completely Agree). The total score is the average of the 4 item scores (possible range: 1 through 5, where 5 is the best possible outcome).
Measured: Endpoint (i.e., at least 8 weeks from resource package receipt)
Feasibility of Intervention Measure - Teacher Report
Teacher-reported total score on the Feasibility of Intervention Measure (FIM), which consists of 4 items on a 5-point Likert scale (from 1 = Completely Disagree to 5 = Completely Agree). The total score is the average of the 4 item scores (possible range: 1 through 5, where 5 is the best possible outcome).
Measured: Endpoint (i.e., at least 8 weeks from resource package receipt)
Acceptability of Intervention Measure - Caregiver Report
Caregiver-reported total score on the Acceptability of Intervention Measure (AIM), which consists of 4 items on a 5-point Likert scale (from 1 = Completely Disagree to 5 = Completely Agree). The total score is the average of the 4 item scores (possible range: 1 through 5, where 5 is the best possible outcome).
Measured: Endpoint (i.e., at least 8 weeks from resource package receipt)
Acceptability of Intervention Measure - Teacher Report
Teacher-reported total score on the Acceptability of Intervention Measure (AIM), which consists of 4 items on a 5-point Likert scale (from 1 = Completely Disagree to 5 = Completely Agree). The total score is the average of the 4 item scores (possible range: 1 through 5, where 5 is the best possible outcome).
Measured: Endpoint (i.e., at least 8 weeks from resource package receipt)
Intervention Appropriateness Measure - Caregiver Report
Caregiver-reported total score on the Intervention Appropriateness Measure (IAM), which consists of 4 items on a 5-point Likert scale (from 1 = Completely Disagree to 5 = Completely Agree). The total score is the average of the 4 item scores (possible range: 1 through 5, where 5 is the best possible outcome).
Measured: Endpoint (i.e., at least 8 weeks from resource package receipt)
Intervention Appropriateness Measure - Teacher Report
Teacher-reported total score on the Intervention Appropriateness Measure (IAM), which consists of 4 items on a 5-point Likert scale (from 1 = Completely Disagree to 5 = Completely Agree). The total score is the average of the 4 item scores (possible range: 1 through 5, where 5 is the best possible outcome).
Measured: Endpoint (i.e., at least 8 weeks from resource package receipt)
Change in teacher-report child performance
Teacher-reported performance items on the National Institute for Children's Health Quality Vanderbilt Scale - Teacher Version; These 8 items are rated on a 5-point scale (from 1 = Excellent to 5 = Problematic). The total score is the average of the 8 item scores (possible range 1 through 5, where 1 is the best possible outcome).
Measured: Baseline, endpoint (i.e., at least 8 weeks from resource package receipt)
Change in caregiver-report child performance
Caregiver-reported performance items on the National Institute for Children's Health Quality Vanderbilt Scale - Parent Version; These 7 items are rated on a 5-point scale (from 1 = Excellent to 5 = Problematic). The total score is the average of the 7 item scores (possible range 1 through 5, where 1 is the best possible outcome).
Measured: Baseline, endpoint (i.e., at least 8 weeks from resource package receipt)
Change in teacher-reported parent-teacher relationship
Teacher-reported items on a 5-item subscale from the Parent-Teacher Involvement Questionnaire. These 5 items are rated on a 5-point scale (from 0 to 4). The total score is the average of the 5 item scores (possible range 0 to 4, where 4 is the best possible outcome).
Measured: Baseline, endpoint (i.e., at least 8 weeks from resource package receipt)
Change in caregiver-reported parent-teacher relationship
Caregiver-reported items on a 6-item subscale from the Parent-Teacher Involvement Questionnaire. These 6 items are rated on a 5-point scale (from 0 = "not at all" to 4 = "a great dael"). The total score is the average of the 6 item scores (possible range 0 to 4, where 4 is the best possible outcome).
Measured: Baseline, endpoint (i.e., at least 8 weeks from resource package receipt)
Change in academic productivity
Teacher-reported Academic Productivity subscale score of the Academic Performance Rating Scale (APRS). The Academic Productivity subscale includes 12 items, each rated on a 5-point Likert scale from 1 to 5. Four items are reverse scored, and the total score is computed as the average of the 12 items (possible range: 1 through 5, where 5 is the best possible outcome).
Measured: Baseline, endpoint (i.e., at least 8 weeks from resource package receipt)
Secondary outcomes (4)
Change in Caregiver-reported ADHD symptoms
Caregiver-reported inattention and hyperactivity/impulsivity symptoms scores on the National Institute for Children's Health Quality Vanderbilt Scale - Parent Version, which consists of 18 items, rated on 4-point scales (from 0 = Never to 3 = Very Often). The total score is calculated as the average of the of the 18 item scores (possible range 0 through 3, where 0 is the best possible outcome).
Measured: Baseline, endpoint (i.e., at least 8 weeks from resource package receipt)
Change in Teacher-reported ADHD symptoms
Teacher-reported inattention and hyperactivity/impulsivity symptoms scores on the National Institute for Children's Health Quality Vanderbilt Scale - Teacher Version, which consists of 18 items, rated on 4-point scales (from 0 = Never to 3 = Very Often). The total score is calculated as the average of the of the 18 item scores (possible range 0 through 3, where 0 is the best possible outcome).
Measured: Baseline, endpoint (i.e., at least 8 weeks from resource package receipt)
Change in Student-Teacher Relationship
Teacher-reported total score on the Student-Teacher Relationship Scale - Short form, which consists of 15 items, rated on a 5-point scale (from 1 = Definitely does not apply to 5 = Definitely applies). Eight items are reverse scored and then the total score is computed as the average of the 15 item scores (possible range: 1 through 5, where 5 is the best possible outcome).
Measured: Baseline, endpoint (i.e., at least 8 weeks from resource package receipt)
Change in academic success
Teacher-reported Academic Success subscale score of the Academic Performance rating Scale (APRS). The Academic Success subscale includes 7 items, each rated on a 5-point Likert scale from 1 to 5. One item is reverse scored, and the total score is computed as the average of the 7 items (possible range: 1 through 5, where 5 is the best possible outcome).
Measured: Baseline, endpoint (i.e., at least 8 weeks from resource package receipt)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start3 Feb 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity Disorder SymptomsStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe 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
- Model description
- Participating teachers, and the students and students' caregivers nested within their classroom, are randomized to one of two conditions: implementation strategy resource package for teacher and caregiver, or implementation strategy resource package for teacher only.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07321327
- Sponsor's protocol ID
- 25-023858
- Status last verified
- Feb 2026
- First submitted
- 22 Dec 2025
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation Strategies for Caregiver and Teacher Use of Behavioral Interventions: Aim 2
- ClinicalTrials.gov ID
- NCT07321327
- Acronym / sponsor ID
- 25-023858
- Keywords
- Attention Deficit Hyperactivity Disorder Positive Behavior Management, Inattentive, Hyperactive, Impulsive
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Study start
- 3 Feb 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 7 Jan 2026 (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.
The purpose of this study is to pilot test for feasibility and initial promise an implementation strategy resource package that aims to support caregivers in using behavioral interventions for children with hyperactive, inattentive, or impulsive behaviors, when provided as an adjunct to a resource package for teachers. Participating children will be randomized at the classroom level to one of two conditions: a) their teacher and caregiver receive the resource package, or b) only their teacher receive the resource package. The research team will examine teacher and caregiver implementation outcomes and mental health outcomes for enrolled children.
Detailed description
Evidence-based interventions for children with or at-risk for Attention Deficit Hyperactivity Disorder (ADHD) include antecedent- and consequence- based behavioral interventions in both the classroom and home settings as well as effective home-school communication approaches. Schools are a promising setting in which to provide early intervention for mental health challenges and to increase access to mental health care. Furthermore, stronger integration between home- and school- based interventions has the potential to meaningfully improve child outcomes. However, there are substantial implementation challenges to caregivers' use of these evidence-based interventions. The purpose of this study is to pilot test for feasibility and initial promise an implementation strategy resource package that aims to support caregivers in using behavioral interventions for children with hyperactive, inattentive, or impulsive behaviors, when provided as an adjunct to a resource package for teachers. Participating children will be randomized at the classroom level to one of two conditions: a) both teacher and caregiver receive the resource package, or b) only the teacher receive the resource package. The research team will examine teacher and caregiver implementation outcomes and mental health outcomes for enrolled children.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participating teachers, and the students and students' caregivers nested within their classroom, are randomized to one of two conditions: implementation strategy resource package for teacher and caregiver, or implementation strategy resource package for teacher only.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Positive Behavior Management Toolkit for Caregivers, Behavioral: Positive Behavioral Management Toolkit for TeachersTeachers in this group will receive an implementation support package and receive support in using it within their classroom management practice. Also within the intervention group (experimental), will be up to 2 students nested in the classroom and their caregivers. Caregivers in this group will receive an implementation support package and receive support in using it. |
| Control Group | Active comparator | Behavioral: Positive Behavioral Management Toolkit for TeachersTeachers in this group will receive an implementation support package and receive support in using it within their classroom management practice. Also within the control group (active comparator) will be up to 2 students nested in the classroom and their caregivers. Caregivers in this group will not receive the implementation resource package. |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| Positive Behavior Management Toolkit for CaregiversAlso: Implementation Strategy Resource Package for Caregivers, Supporting School Success - Caregiver Version (SSS-C)The Positive Behavior Management Toolkit for Caregivers, or the implementation strategy resource package for caregivers, is a set of resources provided that aims to support their use of evidence-based behavior management practices and home-school communication strategies. | Behavioural | Intervention Group |
| Positive Behavioral Management Toolkit for TeachersAlso: Implementation Strategy Resource Package for Teachers, Supporting School Success - Teacher Version (SSS-T)The Positive Behavior Management Toolkit for Teachers, or the implementation strategy resource package for teachers, is a set of resources provided that aims to support their use of evidence-based behavior management practices and home-school communication strategies. | Behavioural | Control Group, Intervention Group |
Primary outcome
Feasibility of Intervention Measure - Caregiver Report
Time frame: Endpoint (i.e., at least 8 weeks from resource package receipt)
Caregiver-reported total score on the Feasibility of Intervention Measure (FIM), which consists of 4 items on a 5-point Likert scale (from 1 = Completely Disagree to 5 = Completely Agree). The total score is the average of the 4 item scores (possible range: 1 through 5, where 5 is the best possible outcome).
Feasibility of Intervention Measure - Teacher Report
Time frame: Endpoint (i.e., at least 8 weeks from resource package receipt)
Teacher-reported total score on the Feasibility of Intervention Measure (FIM), which consists of 4 items on a 5-point Likert scale (from 1 = Completely Disagree to 5 = Completely Agree). The total score is the average of the 4 item scores (possible range: 1 through 5, where 5 is the best possible outcome).
Acceptability of Intervention Measure - Caregiver Report
Time frame: Endpoint (i.e., at least 8 weeks from resource package receipt)
Caregiver-reported total score on the Acceptability of Intervention Measure (AIM), which consists of 4 items on a 5-point Likert scale (from 1 = Completely Disagree to 5 = Completely Agree). The total score is the average of the 4 item scores (possible range: 1 through 5, where 5 is the best possible outcome).
Acceptability of Intervention Measure - Teacher Report
Time frame: Endpoint (i.e., at least 8 weeks from resource package receipt)
Teacher-reported total score on the Acceptability of Intervention Measure (AIM), which consists of 4 items on a 5-point Likert scale (from 1 = Completely Disagree to 5 = Completely Agree). The total score is the average of the 4 item scores (possible range: 1 through 5, where 5 is the best possible outcome).
Intervention Appropriateness Measure - Caregiver Report
Time frame: Endpoint (i.e., at least 8 weeks from resource package receipt)
Caregiver-reported total score on the Intervention Appropriateness Measure (IAM), which consists of 4 items on a 5-point Likert scale (from 1 = Completely Disagree to 5 = Completely Agree). The total score is the average of the 4 item scores (possible range: 1 through 5, where 5 is the best possible outcome).
Intervention Appropriateness Measure - Teacher Report
Time frame: Endpoint (i.e., at least 8 weeks from resource package receipt)
Teacher-reported total score on the Intervention Appropriateness Measure (IAM), which consists of 4 items on a 5-point Likert scale (from 1 = Completely Disagree to 5 = Completely Agree). The total score is the average of the 4 item scores (possible range: 1 through 5, where 5 is the best possible outcome).
Change in teacher-report child performance
Time frame: Baseline, endpoint (i.e., at least 8 weeks from resource package receipt)
Teacher-reported performance items on the National Institute for Children's Health Quality Vanderbilt Scale - Teacher Version; These 8 items are rated on a 5-point scale (from 1 = Excellent to 5 = Problematic). The total score is the average of the 8 item scores (possible range 1 through 5, where 1 is the best possible outcome).
Change in caregiver-report child performance
Time frame: Baseline, endpoint (i.e., at least 8 weeks from resource package receipt)
Caregiver-reported performance items on the National Institute for Children's Health Quality Vanderbilt Scale - Parent Version; These 7 items are rated on a 5-point scale (from 1 = Excellent to 5 = Problematic). The total score is the average of the 7 item scores (possible range 1 through 5, where 1 is the best possible outcome).
Change in teacher-reported parent-teacher relationship
Time frame: Baseline, endpoint (i.e., at least 8 weeks from resource package receipt)
Teacher-reported items on a 5-item subscale from the Parent-Teacher Involvement Questionnaire. These 5 items are rated on a 5-point scale (from 0 to 4). The total score is the average of the 5 item scores (possible range 0 to 4, where 4 is the best possible outcome).
Change in caregiver-reported parent-teacher relationship
Time frame: Baseline, endpoint (i.e., at least 8 weeks from resource package receipt)
Caregiver-reported items on a 6-item subscale from the Parent-Teacher Involvement Questionnaire. These 6 items are rated on a 5-point scale (from 0 = "not at all" to 4 = "a great dael"). The total score is the average of the 6 item scores (possible range 0 to 4, where 4 is the best possible outcome).
Change in academic productivity
Time frame: Baseline, endpoint (i.e., at least 8 weeks from resource package receipt)
Teacher-reported Academic Productivity subscale score of the Academic Performance Rating Scale (APRS). The Academic Productivity subscale includes 12 items, each rated on a 5-point Likert scale from 1 to 5. Four items are reverse scored, and the total score is computed as the average of the 12 items (possible range: 1 through 5, where 5 is the best possible outcome).
4 secondary outcomes
Change in Caregiver-reported ADHD symptoms
Time frame: Baseline, endpoint (i.e., at least 8 weeks from resource package receipt)
Change in Teacher-reported ADHD symptoms
Time frame: Baseline, endpoint (i.e., at least 8 weeks from resource package receipt)
Change in Student-Teacher Relationship
Time frame: Baseline, endpoint (i.e., at least 8 weeks from resource package receipt)
Change in academic success
Time frame: Baseline, endpoint (i.e., at least 8 weeks from resource package receipt)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positive Behavior Management Toolkit for Caregivers and Positive Behavioral Management Toolkit for Teachers in people with Attention Deficit Hyperactivity Disorder Symptoms, run by Children's Hospital of Philadelphia 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?
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: enrolling by invitation, as of the sponsor's last update on 5 Feb 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Feasibility of Intervention Measure - Caregiver Report (time frame: Endpoint (i.e., at least 8 weeks from resource package receipt)). The study lists 11 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 5 Feb 2026.