Caregiver Implementation Strategies Field Pre-Test

NCT06770036 | Completed

• 2 other identifiers: 24-021965R34MH132718-01A1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Attention Deficit Hyperactivity Disorder Symptoms

Keywords

Attention Deficit Hyperactivity Disorder; Positive Behavior Management; Inattentive; Hyperactive; Impulsive

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  Baseline, Endpoint (i.e, at least 8 weeks from resource package receipt)

Study Arms (1)

Caregiver Resource Package

EXPERIMENTAL

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

Behavioral: Implementation Resource Package for Caregivers

Interventions

Implementation Resource Package for Caregivers BEHAVIORAL

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.

Also known as: Supporting School Success - Caregiver Version, Positive Behavior Management Toolkit for Caregivers

Caregiver Resource Package

Eligibility Criteria

• Age: 4 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19146, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Spasm; Impulsive Behavior

Interventions

Caregivers

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Health Personnel; Health Care Facilities Workforce and Services

Study Officials

• Gwendolyn M Lawson, PhD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2025
• First Posted: January 13, 2025
• Study Start: July 30, 2025
• Primary Completion: January 21, 2026
• Study Completion: January 23, 2026
• Last Updated: January 26, 2026

Record last verified: 2026-01

Locations

US (1)