NCT06305429

Brief Summary

This study evaluates the feasibility and preliminary impacts of a new parenting program consisting of a series of educational videos, automatically delivered via a popular texting platform. The program content for the feasibility study is focused on teaching parents strategies to better manage one of the commonly reported challenges that children face, a transition to a non-preferred activity. Parents with young children experiencing behavior difficulties with daily transition routines are invited to participate in the study.

Trial Health

57
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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2024

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 5, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 12, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

October 15, 2024

Status Verified

October 1, 2024

Enrollment Period

1 year

First QC Date

March 5, 2024

Last Update Submit

October 10, 2024

Conditions

Keywords

ADHDParent TrainingTreatment Access

Outcome Measures

Primary Outcomes (3)

  • Number of videos viewed

    The number of videos viewed (minimum 0, maximum 5) to evaluate participant engagement

    1 month

  • Percentage of completed daily ratings

    The percentage of completed daily ratings (minimum 0, maximum 17). Parents are asked to provide daily ratings on the degree of success in implementing parenting strategies taught.

    1 month

  • Participant satisfaction

    The parent-rated satisfaction regarding information presented in the videos. A rating completed after each video viewing using a 4-point scale. Averaged across the ratings completed for the videos viewed. (Minimum 0, maximum 4). Higher scores indicate greater satisfaction.

    1 month

Secondary Outcomes (6)

  • Parent-rated child's difficulties with daily transitions

    1 month

  • Parent-rated child's impairment related to transition difficulties

    1 month

  • Inconsistent parenting

    1 month

  • Use of physical control

    1 month

  • Hostility toward child

    1 month

  • +1 more secondary outcomes

Other Outcomes (5)

  • ADHD symptoms

    1 month

  • ODD symptoms

    1 month

  • Irritability

    1 month

  • +2 more other outcomes

Study Arms (1)

Feasibility testing of an education program promoting effective parenting habit

EXPERIMENTAL

Parents will receive a series of 6 short videos via Whatsapp

Behavioral: HabitE (effective parenting habit) program (in Brazilian Portuguese)

Interventions

Parents who enroll in the program will receive a series of 6 videos (\~ 7 minutes each), 1 video at a time, generally every 3 days. They will also receive daily written texts, which include implementation tips and an assessment of a target (transition) behavior.

Feasibility testing of an education program promoting effective parenting habit

Eligibility Criteria

Age4 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Parents of children aged from 4 to 10 years old
  • Parents experiencing behavior difficulties with daily transition routines (parent-report).

You may not qualify if:

  • Parents that do not have the children living with them at least 5 days per week every week;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto D'or de Pesquisa e Ensino (IDOR)

Brazil, Brazil

RECRUITING

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Open, single-group trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

March 5, 2024

First Posted

March 12, 2024

Study Start

June 1, 2024

Primary Completion

June 1, 2025

Study Completion

July 1, 2025

Last Updated

October 15, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations