NCT05145920

Brief Summary

This study evaluates the feasibility and preliminary impacts of a new parenting program consisting of a series of educational videos, delivered via a popular texting platform. For this pilot project, the program content 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 demonstrating behavior consistent with ADHD and experiencing difficulties with daily transition routines are invited to participate in the study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2021

Geographic Reach
1 country

1 active site

Status
completed

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

September 27, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 6, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 24, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 24, 2022

Completed
Last Updated

April 25, 2023

Status Verified

April 1, 2023

Enrollment Period

12 months

First QC Date

September 27, 2021

Last Update Submit

April 24, 2023

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 (5)

  • Parent-rated child's difficulties with daily transitions

    1 month

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

    1 month

  • Proactive parenting

    1 month

  • Use of positive reinforcement

    1 month

  • Hostility toward child

    1 month

Other Outcomes (3)

  • ADHD symptoms

    1 month

  • ODD symptoms

    1 month

  • Irritability

    1 month

Study Arms (1)

Pilot testing of an education program promoting effective parenting habit

EXPERIMENTAL

Parents will receive a series of 5 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 5 videos (\~ 7 minutes each), 1 video at a time, generally every 3 days. Parents will also receive daily written texts, which include implementation tips and an assessment of a target (transition) behavior.

Pilot testing of an education program promoting effective parenting habit

Eligibility Criteria

Age4 Years - 8 Years
Sexall(Gender-based eligibility)
Gender Eligibility Details4 years to 8 years (Child)
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Parents of children, aged 4-8, who demonstrate behavior symptoms consistent with ADHD symptoms, i.e., at least 4 inattention and/or 4 hyperactivity/impulsivity symptoms (parent-report). The number of symptoms is lower than the diagnostic threshold to include those with emerging problems. No diagnosis will be made or confirmed in the study. Children need to live with the participating parents at least 5 days per week every week.

You may not qualify if:

  • Parents of children who have received other forms of pharmacological and/or non-pharmacological treatment in the past 3 months. These parents will be asked to wait to receive other forms of treatment until they complete the study participation.
  • Parents of children demonstrating symptoms consistent with Autism Spectrum Disorder, and those other difficulties (severe learning, mood and anxiety problems and environmental issues \[e.g., recent divorce\]) that would better explain the child's challenges transition routines.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

D'Or Institute for Research

Rio de Janeiro, 22281-100, Brazil

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Paulo E Mattos, MD, PhD

    D'Or Institute for Research and Eduaction

    PRINCIPAL INVESTIGATOR

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
SPONSOR

Study Record Dates

First Submitted

September 27, 2021

First Posted

December 6, 2021

Study Start

November 1, 2021

Primary Completion

October 24, 2022

Study Completion

October 24, 2022

Last Updated

April 25, 2023

Record last verified: 2023-04

Locations