Digital Support Strategies for Caregiver Home Practice

NCT06907966 | Recruiting

• 2 other identifiers: STUDY00014233K01DA055118
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

This project is a pilot trial of the Engaging Families home practice smartphone application (or "app") as an add on to a family-based prevention program. Although there are many evidence-based preventive interventions delivered to caregivers to prevent youth substance use and mental illness and promote youth positive family and youth outcomes, the impact of these interventions is often limited by low home practice of intervention skills among caregivers. The Engaging Families home practice app is a digital behavior change intervention that was developed to support caregivers in practicing intervention skills at home. Researchers will ask participants if the app was acceptable and feasible for daily use at home. Researchers may also compare how often caregivers who use the study app do home practice of intervention skills compared with caregivers who do not receive the home practice app but are encouraged to use an app to help schedule their activities.

Conditions

Acceptability; Feasibility Studies

Keywords

home practice; parenting; skills practice

Outcome Measures

Primary Outcomes (3)

• Acceptability of the intervention

  Acceptability of the intervention will be assessed using the Acceptability of Intervention Measure (AIM). This measure was developed specifically to support assessing the acceptability of implementation of a new intervention. Psychometric properties of this measure were assessed in prior studies. The final measures exhibited discriminate content validity and acceptable model fit. See Weiner, B.J., Lewis, C.C., Stanick, C. et al. Psychometric assessment of three newly developed implementation outcome measures. Implementation Sci 12, 108 (2017). https://doi.org/10.1186/s13012-017-0635-3 for more information. The following items are rated on a 5-point Likert-type scale (Complete disagree to Completely agree): \[This program\] meets my approval. \[This program\] is appealing to me. I like \[this program\]. I welcome \[this program\].

  Post-intervention, approximately 2-3 months post baseline

• Intervention Feasibility

  Feasibility of the intervention will be assessed using the Feasibility of Intervention Measure (AIM). This measure was developed specifically to support assessing the feasibility of implementation of a new intervention. Psychometric properties of this measure were assessed in prior studies. The final measures exhibited discriminate content validity and acceptable model fit. See Weiner, B.J., Lewis, C.C., Stanick, C. et al. Psychometric assessment of three newly developed implementation outcome measures. Implementation Sci 12, 108 (2017). https://doi.org/10.1186/s13012-017-0635-3 for more information. The following items are rated on a 5-point Likert-type scale (Complete disagree to Completely agree): 1. (THIS INTERVENTION) seems implementable. 2. (THIS INTERVENTION) seems possible. 3. (THIS INTERVENTION) seems doable. 4. (THIS INTERVENTION) seems easy to use.

  Post-intervention, approximately 2-3 months post baseline

• Home practice of skills

  At Sessions 2, 3, and 4, parents will respond to three questions about their experience completing home practice on a 6-point Likert-type scale: How many times did you practice \[the skill\]? (0 = did no practice to 5+ times) How well are you able to use \[the skill\] with your teen? (0 = did not practice, 1 = not at all to 5 = very well) How helpful was it to use \[the skill\] with your teen? (0 = did not practice, 1 = not at all to 5 = very helpful)

  3 times during the intervention, up to 8 weeks

Study Arms (2)

Engaging Families App

EXPERIMENTAL

Participants in this arm will receive the Engaging Families home practice app

Behavioral: Engaging Families home practice app

Active control app

ACTIVE COMPARATOR

Other: Scheduling app

Interventions

Engaging Families home practice app BEHAVIORAL

The intervention is a smartphone application (or "app") that was developed to support caregiver home practice of intervention skills. The app was designed to support caregivers participating in the Bridges program, an evidence-based, family-based preventive intervention. Features of the app were developed to help caregivers overcome common barriers to practicing intervention skills at home.

Engaging Families App

Scheduling app OTHER

The Cozi Family Organizer is a smartphone application that will be given to caregivers randomized to the active control group. Cozi is a highly rated family organization app with features that include a family calendar, to do list, shopping list, and daily agenda. Cozi is available on Android and iPhone devices.

Active control app

Eligibility Criteria

• Age: 11 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent
• Ownership and regular use of a smartphone
• English or Spanish language fluency
• Concurrent enrollment in the family-based EBI Bridges
• Parent of a child aged 11-17 years old

You may not qualify if:

• \- Decline to download the home practice app on their personal smartphone.
• Parent/guardian consent
• Informed assent
• Parent is enrolled in the study
• English reading ability at the 4th grade level or higher
• No parent/guardian consent
• Parent/guardian is not enrolled in the study concurrently

Sponsors & Collaborators

• Arizona State University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Arizona State University

Tempe, Arizona, 85287, United States

RECRUITING

Related Links

• Project details from NIH Reporter

Central Study Contacts

Joanna J Kim, PhD

CONTACT

16024965748; JoannaKim@asu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 18, 2025
• First Posted: April 3, 2025
• Study Start: March 17, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: June 25, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)