NCT07170553

Brief Summary

The purpose of this study is to test a new digital game. Specifically, this study will aim to evaluate a digital game prototype designed to facilitate playful interactions between parents and children. The prototype will incorporate activities grounded in relationship enhancement principles. Additionally, this study will check how well using digital tools helps build strong connections, makes people get along better, and boosts parents' confidence and parenting skills.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
11mo left

Started Jun 2026

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 5, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 12, 2025

Completed
9 months until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2027

Last Updated

March 3, 2026

Status Verified

February 1, 2026

Enrollment Period

11 months

First QC Date

September 5, 2025

Last Update Submit

February 27, 2026

Conditions

Keywords

Digital InterventionAttachment Based

Outcome Measures

Primary Outcomes (1)

  • Parental Self-Efficacy as Measured by TOPSE

    Tool to Measure Parenting Self-Efficacy (TOPSE) Total scores range from 0-480 for the complete measure. Higher scores indicate greater levels of perceived parental self-efficacy.

    Baseline, Up to 1.5 hours (immediately after intervention).

Secondary Outcomes (1)

  • Perceived Closeness in the Parent-Child Relationship as measured by the Social Connectedness Scale

    Baseline, Up to 1.5 hours (immediately after intervention).

Study Arms (2)

Caregiver Child Digital Intervention Group

EXPERIMENTAL

Participants in this group will engage with the intervention for up to 1 hour.

Behavioral: Digital Game

Control Group

ACTIVE COMPARATOR

Participants in this group will receive information about play based attachment activities and participate for up to 1 hour.

Behavioral: Control

Interventions

Digital GameBEHAVIORAL

Parent-child dyads will come to the research site once and participate for up to one hour. Dyads will engage with a digital game prototype. The game involves brief relationship enhancing activities focused on different domains of attachment with the purpose of facilitating appropriate and healthy playful interaction between parents and children.

Caregiver Child Digital Intervention Group
ControlBEHAVIORAL

Parent-child dyads will come to the research site once and participate for up to one hour. Dyads will receive pamphlets with information regarding play based attachment activities and be given the chance to engage in said activities.

Control Group

Eligibility Criteria

Age6 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Caregiver-child dyads.

You may not qualify if:

  • Participant is not part of a caregiver- child dyad.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Miami

Coral Gables, Florida, 33146, United States

RECRUITING

University of Miami

Miami, Florida, 33146, United States

NOT YET RECRUITING

Study Officials

  • Anna Queiroz, PhD

    University of Miami

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Queiroz, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 5, 2025

First Posted

September 12, 2025

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

April 30, 2027

Last Updated

March 3, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations