Attention Deficit Hyperactivity Disorder SymptomsNCT06770036
Caregiver Implementation Strategies Field Pre-Test
A study testing Implementation Resource Package for Caregivers 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 field pre-test an implementation strategy resource package that aims to support caregivers in using behavioral interventions for children with hyperactive, inattentive, or impulsive behaviors. Enrolled caregivers will be assigned to use the resource package with their children. Read more about this study
- Who is it for?
- Ages 4 years and older
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder Symptoms
- What is being tested?
- Implementation Resource Package for Caregivers
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jul 2025to 23 Jan 2026
- 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 4 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Students in or entering grades K-5 in the greater Philadelphia area
- Nominated for participation by a school staff member or parent/legal guardian
- Identified by that staff member or parent/legal guardian 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.
Who cannot join
- 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
- Special education classification of 'intellectual disability'
- 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.
United States1 site
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19146
About this study
Official title: Implementation Strategies for Caregiver and Teacher Use of Behavioral Interventions With ADHD: A Pilot Study, Aim 1
The purpose of this study is to field pre-test an implementation strategy resource package that aims to support caregivers in using behavioral interventions for children with hyperactive, inattentive, or impulsive behaviors. Enrolled caregivers will be assigned to use the resource package with their children. The research team will collect quantitative and qualitative data regarding acceptability, appropriateness, and feasibility, in preparation for a randomized pilot study.
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. This study aims to field pre-test an implementation strategy resource package to support caregivers in using evidence-based behavioral interventions for children with hyperactive, inattentive, or impulsive behaviors. After an initial iterative process of developing the resource package, enrolled caregivers will use the resource package with their children in a single-arm study, for the purpose of assessing initial implementation outcomes and making final adjustments to the resource package.
- Being tested
- Implementation Resource Package for Caregivers
- Keywords
- Attention Deficit Hyperactivity Disorder, Positive Behavior Management, Inattentive, Hyperactive, Impulsive
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Spasm, Impulsive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implementation Resource Package for CaregiversBehavioural
Also called Supporting School Success - Caregiver Version, Positive Behavior Management Toolkit for Caregivers
The implementation resource package for caregivers is a set of resources provided to caregivers that aims to support their use of evidence-based behavior management practices and home-school communication strategies.
| Study group | Role | What they receive |
|---|---|---|
| Caregiver Resource Package | Experimental | Caregiver in this group will receive an implementation resource support package and will receive support in using it. Receives: Behavioral: Implementation Resource Package for Caregivers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Intervention Measure
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.
Measured: Endpoint (i.e, at least 8 weeks from resource package receipt)
Acceptability of Intervention Measure
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.
Measured: Endpoint (i.e, at least 8 weeks from resource package receipt)
Intervention Appropriateness Measure
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.
Measured: Endpoint (i.e, at least 8 weeks from resource package receipt)
Change in observed caregiver fidelity to behavioral interventions
A member of the study will conduct observations to measure fidelity of caregiver use of the behavioral interventions.
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 posted13 Jan 2025
- Study start30 Jul 2025
- Primary completion21 Jan 2026
- Study completion23 Jan 2026
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Gwendolyn M Lawson, PhD, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06770036
- Sponsor's protocol ID
- 24-021965
- Other IDs
- R34MH132718-01A1
- Status last verified
- Jan 2026
- First submitted
- 9 Jan 2025
- Last updated
- 26 Jan 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 26 Jan 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 With ADHD: A Pilot Study, Aim 1
- ClinicalTrials.gov ID
- NCT06770036
- Acronym / sponsor ID
- 24-021965
- Keywords
- Attention Deficit Hyperactivity Disorder, Positive Behavior Management, Inattentive, Hyperactive, Impulsive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 30 Jul 2025 (actual)
- Primary completion
- 21 Jan 2026 (actual)
- Study completion
- 23 Jan 2026 (actual)
- First posted
- 13 Jan 2025 (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 field pre-test an implementation strategy resource package that aims to support caregivers in using behavioral interventions for children with hyperactive, inattentive, or impulsive behaviors. Enrolled caregivers will be assigned to use the resource package with their children. The research team will collect quantitative and qualitative data regarding acceptability, appropriateness, and feasibility, in preparation for a randomized pilot study.
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. This study aims to field pre-test an implementation strategy resource package to support caregivers in using evidence-based behavioral interventions for children with hyperactive, inattentive, or impulsive behaviors. After an initial iterative process of developing the resource package, enrolled caregivers will use the resource package with their children in a single-arm study, for the purpose of assessing initial implementation outcomes and making final adjustments to the resource package.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Caregiver Resource Package | Experimental | Behavioral: Implementation Resource Package for CaregiversCaregiver in this group will receive an implementation resource support package and will receive support in using it. |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Students in or entering grades K-5 in the greater Philadelphia area
- Nominated for participation by a school staff member or parent/legal guardian
- Identified by that staff member or parent/legal guardian 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.
Key exclusion criteria (3 listed)
- 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
- Special education classification of 'intellectual disability'
- 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
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 |
|---|---|---|
| Implementation Resource Package for CaregiversAlso: Supporting School Success - Caregiver Version, Positive Behavior Management Toolkit for CaregiversThe implementation resource package for caregivers is a set of resources provided to caregivers that aims to support their use of evidence-based behavior management practices and home-school communication strategies. | Behavioural | Caregiver Resource Package |
Primary outcome
Feasibility of Intervention Measure
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.
Acceptability of Intervention Measure
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.
Intervention Appropriateness Measure
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.
Change in observed caregiver fidelity to behavioral interventions
Time frame: Baseline, Endpoint (i.e, at least 8 weeks from resource package receipt)
A member of the study will conduct observations to measure fidelity of caregiver use of the behavioral interventions.
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 26 Jan 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. This study is not recruiting at the moment.
Gwendolyn M Lawson, PhD principal investigator
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implementation Resource Package for Caregivers 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?
The sponsor lists 3 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 26 Jan 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?
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?
Feasibility of Intervention Measure (time frame: Endpoint (i.e, at least 8 weeks from resource package receipt)). The study lists 4 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 26 Jan 2026.