Clinical trial NCT06770036: Caregiver Implementation Strategies Field Pre-Test
Official title: Implementation Strategies for Caregiver and Teacher Use of Behavioral Interventions With ADHD: A Pilot Study, Aim 1
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder Symptoms
Keywords: Attention Deficit Hyperactivity Disorder
Positive Behavior Management
Inattentive
Hyperactive
Impulsive
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2025-01-13
Enrollment: 33
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* Grades K-5
* 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.

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'
* 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

Primary outcomes:
measure: Feasibility of Intervention Measure
timeFrame: Endpoint (i.e, at least 8 weeks from resource package receipt)
measure: Acceptability of Intervention Measure
timeFrame: Endpoint (i.e, at least 8 weeks from resource package receipt)
measure: Intervention Appropriateness Measure
timeFrame: Endpoint (i.e, at least 8 weeks from resource package receipt)
measure: Change in observed caregiver fidelity to behavioral interventions
timeFrame: Baseline, Endpoint (i.e, at least 8 weeks from resource package receipt)
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Gwendolyn M Lawson, PhD
role: PRINCIPAL_INVESTIGATOR
References: