Caregiver Strategies for ADHD

Overseen By Gwendolyn Lawson, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital of Philadelphia

Disqualifiers: Acute harm risk, Intellectual disability, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new resource package designed to help caregivers use behavioral strategies for children with ADHD-like symptoms, such as hyperactivity or inattention. The goal is to determine if the package is easy to use and effective before conducting a larger study. Caregivers of children in grades K-5 in the Philadelphia area, identified as struggling with ADHD symptoms, may be suitable participants.

As an unphased trial, this study allows caregivers to contribute to the development of innovative strategies that could benefit children with ADHD symptoms.

Will I have to stop taking my current medications?

The trial does not specify whether participants need to stop taking their current medications.

What prior data suggests that this implementation strategy resource package is safe for caregivers and children?

A previous study provided caregivers with resources to help manage children's ADHD behaviors using behavior-based strategies. Researchers created these resources to assist caregivers effectively. The study evaluated caregivers' acceptance and use of these resources, as well as their ease of use. Caregivers reported no harmful effects or negative experiences, suggesting that the approach is safe and well-received. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Caregiver Resource Package because it offers a fresh approach to managing ADHD by involving caregivers directly in the treatment process. Unlike standard treatments that primarily focus on medication or therapist-led interventions, this package empowers caregivers with resources and support to implement strategies at home. This approach not only aims to enhance the child's environment but also equips caregivers with tools to better manage ADHD symptoms, potentially leading to more sustainable and personalized outcomes.

What evidence suggests that this caregiver resource package is effective for ADHD?

Research has shown that teaching caregivers about ADHD can significantly enhance their understanding of the condition. One study found that caregivers' knowledge of ADHD increased by 18% after participating in similar educational programs, reaching an average knowledge level of 75%. In this trial, caregivers in the "Caregiver Resource Package" arm will receive an implementation resource support package and guidance on its use. These programs aim to help caregivers better manage the hyperactive, inattentive, or impulsive behaviors of children with ADHD. Managing these challenges can be demanding, so effective tools and strategies can make a significant difference. This approach not only supports caregivers but also aims to improve outcomes for children by increasing caregiver involvement and the use of behavioral strategies. ^{1 6 7 8 9}

Who Is on the Research Team?

Gwendolyn M Lawson, PhD

Principal Investigator

Children's Hospital of Philadelphia

Are You a Good Fit for This Trial?

This trial is for caregivers of children showing hyperactive, inattentive, or impulsive behaviors which may be related to conditions like ADHD. Caregivers willing to use a new resource package and provide feedback on its usefulness are ideal candidates.

Inclusion Criteria

I am in grades K-5.

Nominated for participation by a school staff member

Identified by that staff member as displaying functional impairment from ADHD symptoms, as measured by a score of 3 or greater on the modified version of the Impairment Rating Scale.

Exclusion Criteria

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'

My family does not have a caregiver who speaks English, so I am not eligible.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Caregivers use the implementation strategy resource package with their children to support behavioral interventions

8 weeks

Ongoing support provided

Follow-up

Participants are monitored for acceptability, appropriateness, and feasibility of the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Caregiver Implementation Strategies Field Pre-Test

Trial Overview The study tests an 'Implementation Resource Package' designed for caregivers. It aims to help manage children's behavioral issues associated with ADHD. The effectiveness will be measured through caregiver feedback before moving on to a larger test.

How Is the Trial Designed?

Group I: Caregiver Resource Package Experimental Treatment 1 Intervention

Caregiver in this group will receive an implementation resource support package and will receive support in using it.

Who Is Running the Clinical Trial?

Children's Hospital of Philadelphia

Lead Sponsor

Trials

749

Recruited

11,400,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

A study involving 136 families of children aged 6 to 12 with ADHD showed that a telephone-assisted self-help intervention led to significant improvements in ADHD symptoms, oppositional defiant disorder symptoms, and overall behavioral problems during the intervention and maintained these improvements at follow-up.

The intervention not only improved child behavior problems but also enhanced the quality of life for families, indicating that guided self-help can be an effective long-term strategy for managing ADHD in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Effectiveness of Guided Self-Help for Parents of Children With ADHD in Routine Care-An Observational Study. Döpfner, M., Liebermann-Jordanidis, H., Kinnen, C., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06770036

Caregiver Implementation Strategies Field Pre-Test | ... 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12198261/

Effectiveness and cost-effectiveness of interventions to ... Post-test knowledge of ADHD demonstrated a statistically significant improvement from pre-test (t = −17.21, p < 0.01) of 18%; a mean of 75% at ...

3. ies.ed.gov ies.ed.gov/use-work/awards/early-intervention-young-children-adhd-developing-strategies-enhance-parent-engagement

Early Intervention for Young Children with ADHD: Developing ... This draft intervention was field tested, revised based on results of the field test (child outcomes, parent feedback, observations of parent implementation of ...

4. sciencedirect.com sciencedirect.com/org/science/article/pii/S1462373025000392

Caregiver Burden of Children with Attention Deficit ... This systematic review study found strong support that caregivers of children with ADHD experience increased burdens managing the challenges of ...

5. link.springer.com link.springer.com/article/10.1007/s00787-025-02646-4

Effectiveness and cost-effectiveness of interventions to ... This review synthesizes evidence on the effectiveness and cost-effectiveness of interventions to increase ADHD awareness and knowledge for caregivers, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10637083/

Parent/Caregiver Experiences of a CAMHS ADHD ... A recent service evaluation suggested that exploring parental perceptions of a child's ADHD assessment pathway could be beneficial in understanding experiences.

7. implementationscience.biomedcentral.com implementationscience.biomedcentral.com/articles/10.1186/s13012-022-01195-7

study protocol for a cluster-randomized hybrid type III trial This statewide trial is one of the first to test the unique and synergistic effects of implementation strategies targeting care teams and practice leadership.

8. aspe.hhs.gov aspe.hhs.gov/sites/default/files/documents/a5148b1d9c91ba4c7e32abdc84ec3d73/barriers-adhd-disorder-adult-diagnosis.pdf

Barriers to Attention-Deficit/Hyperactivity Disorder ... An analysis of nationally representative data on physician office visits found a 36-percent increase in adult ADHD diagnoses from 2008 to 2013 ( ...

9. publications.aap.org publications.aap.org/pediatrics/article/156/3/e2025073172/203217/Promoting-Optimal-Development-Screening-for-Mental

Screening for Mental Health, Emotional, and Behavioral ... This report outlines specific guidance for MEB screening, identification, and care of children in pediatric primary care. Screening, as part of ...