- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06305429
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
Recruiting
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Estimated)
200
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
- Name: Camila Bernardes
- Phone Number: +5521966834545
- Email: camila.bfaria@idor.org
Study Locations
-
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
Experimental: Feasibility testing of an education program promoting effective parenting habit
Parents will receive a series of 6 short videos via Whatsapp
|
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
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
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
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.
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)
June 1, 2024
Primary Completion (Estimated)
June 1, 2025
Study Completion (Estimated)
July 1, 2025
Study Registration Dates
First Submitted
March 5, 2024
First Submitted That Met QC Criteria
March 5, 2024
First Posted (Actual)
March 12, 2024
Study Record Updates
Last Update Posted (Actual)
October 15, 2024
Last Update Submitted That Met QC Criteria
October 10, 2024
Last Verified
October 1, 2024
More Information
Terms related to this study
Keywords
Other Study ID 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.
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