Digital Support Strategies for Caregiver Home Practice

June 19, 2025 updated by: JoannaKim@asu.edu, Arizona State University

Digital Implementation Support Strategies for Caregiver Home Practice

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The goals of the current pilot trial are to examine the acceptability and feasibility of the Engaging Families home practice smartphone application (or "app"). The Engaging Families app was developed and designed to support families who are already enrolled in and participating in the family-based prevention program Bridges. Families will be assigned to either receive the Engaging Families home practice app or another app to support parents' home practice of skills that they learn during the Bridges program. Acceptability and feasibility as well as preliminary effects will be assessed via survey measures. Select participants will be invited to participate in a post-intervention interview to also assess acceptability and feasibility of the app intervention.

Study Type

Interventional

Enrollment (Estimated)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Caregiver Inclusion Criteria:

  • 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

Caregiver Exclusion Criteria:

- Decline to download the home practice app on their personal smartphone.

Child Inclusion Criteria:

  • Parent/guardian consent
  • Informed assent
  • Parent is enrolled in the study
  • English reading ability at the 4th grade level or higher

Child Exclusion Criteria:

  • No parent/guardian consent
  • Parent/guardian is not enrolled in the study concurrently

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Engaging Families App
Participants in this arm will receive the Engaging Families home practice app
Behavioral: Engaging Families home practice app
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.
Active Comparator: Active control app
Other: Scheduling app
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability of the intervention
Time Frame: Post-intervention, approximately 2-3 months post baseline

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
Time Frame: Post-intervention, approximately 2-3 months post baseline

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
Time Frame: 3 times during the intervention, up to 8 weeks

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arizona State University

Collaborators

National Institute on Drug Abuse (NIDA)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 17, 2025

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

February 18, 2025

First Submitted That Met QC Criteria

April 1, 2025

First Posted (Actual)

April 3, 2025

Study Record Updates

Last Update Posted (Estimated)

June 25, 2025

Last Update Submitted That Met QC Criteria

June 19, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • STUDY00014233
  • K01DA055118 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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