Encouraging Positive Parenting Habits (HABITE)

October 10, 2024 updated by: Paulo Eduardo Luiz de Mattos, D'Or Institute for Research and Education

Encouraging Positive Parenting Habits Through Digital Media: Feasibility Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This feasibility study employs a pre-post, open trial design with the primary aim to investigate the feasibility of the automated delivery of parenting educational materials via a widely used texting platform. The training videos demonstrate the applications of antecedent- and reinforcement-based behavior management techniques in a specific situation and encourage parents to build positive parenting habits. The program usability and satisfaction will be assessed through daily interactions of the participants with the program and post-program questionnaires. The study targets parents of children demonstrating behavioral difficulties managing everyday routines at home, while having difficulty accessing traditional forms of psychosocial treatment. In particular, children of ADHD often experience these difficulties, potential participants are informed that the program is for children demonstrating behaviors consistent with ADHD, and ADHD symptoms will be evaluated pre- and post-program participation, although the presence of the disorder will not be required for the program participation. The investigators expect parents to engage well in the program delivered via digital media. Based on the existing literature on the effectiveness of behavior parent training delivered in traditional in-person format, the investigators expect a moderate effect size in the pre-post measures of parenting practices and the child target behavior for this study.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Brazil
      • Brazil, Brazil
        • Recruiting
        • Instituto D'Or de Pesquisa e Ensino (IDOR)

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

    • While participating parents are informed that the program was developed for children demonstrating symptoms of ADHD, the low symptom number will not be used as an exclusion criteria.

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: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Feasibility testing of an education program promoting effective parenting habit
Parents will receive a series of 6 short videos via Whatsapp
Behavioral: HabitE (effective parenting habit) program (in Brazilian Portuguese)
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of completed daily ratings
Time Frame: 1 month
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
Time Frame: 1 month
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
Number of videos viewed
Time Frame: 1 month
The number of videos viewed (minimum 0, maximum 5) to evaluate participant engagement
1 month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Parent-rated child's difficulties with daily transitions
Time Frame: 1 month
The parent-rated child's difficulties with 9 common daily transitions. Ratings completed before and after the intervention using a 3-point scale. Averaged across the ratings completed for the 9 transitions. Higher scores indicate greater difficulties.
1 month
Parent-rated child's impairment related to transition difficulties
Time Frame: 1 month
The parent-rated level of impairment caused by transition difficulties (1 item). Ratings completed before and after the intervention using a 7 point scale. Higher scores indicate greater impairment.
1 month
Inconsistent parenting
Time Frame: 1 month
Multidimensional Assessment of Parenting Scale (MAPS) Lax Control subscale. Parent ratings completed before and after the intervention using a 5-point scale. Average across 6 items. Lower scores indicate less frequent incidents of inconsistent parenting.
1 month
Use of physical control
Time Frame: 1 month
MAPS Physical Control. Parent ratings completed before and after the intervention using a 5-point scale. Average across 4 items. Lower scores indicate less frequent use of physical disciplines.
1 month
Hostility toward child
Time Frame: 1 month
MAPS Hostility subscale. Parent ratings completed before and after the intervention using a 5-point scale. Average across 7 items. Lower scores indicate less frequent use of hostile reactions during parent-child interactions.
1 month
Parent Stress
Time Frame: 1 month
Parent stress scale. Parent ratings completed before and after the intervention using a 5-point scale. Average across 18 items. Lower scores indicate lower levels of stress.
1 month

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
ADHD symptoms
Time Frame: 1 month
Strengths and Weakness of Attention-Deficit/Hyperactivity Disorder Symptoms and Normal Behavior Scale (SWAN) inattention and hyperactivity/impulsivity symptoms total. Parent ratings completed before and after the intervention using a 7-point scale. Averaged across 18 items. Higher scores indicate ADHD symptoms more frequently observed.
1 month
ODD symptoms
Time Frame: 1 month
SWAN oppositional/defiant symptoms total. Parent ratings completed before and after the intervention using a 7-point scale. Averaged across 8 items. Higher scores indicate ODD symptoms more frequently observed.
1 month
Irritability
Time Frame: 1 month
Affective Reactivity Index (ARI). Parent ratings completed before and after the intervention using a 3-point scale. Averaged across 6 items. Higher scores indicate irritability more frequently observed.
1 month
Proactive parenting
Time Frame: 1 month
MAPS Proactive Parenting subscale. Parent ratings completed before and after the intervention using a 5-point scale. Average across 6 items. Lower scores indicate less frequent incidents of inconsistent parenting.
1 month
Use of positive reinforcement
Time Frame: 1 month
MAPS Positive Reinforcement subscale. Parent ratings completed before and after the intervention using a 5-point scale. Average across 4 items. Lower scores indicate less frequent use of physical disciplines.
1 month

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
D'Or Institute for Research and Education

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Okinawa Institute of Science and Technology Graduate University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 5, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 5, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 12, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 15, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 10, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HABITE

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

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings