- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05145920
Encouraging Positive Parenting Habits Through Digital Media (Habite)
April 24, 2023 updated by: D'Or Institute for Research and Education
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This pilot study employs a pre-post, open trial design with the primary aim to investigate the feasibility of delivering parenting educational materials in a highly accessible format, i.e., 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 ratings and answers to open-ended questions by participating parents.
The study targets parents of children demonstrating symptoms of ADHD.
These families frequently experience difficulties managing everyday routines at home, yet the access to psychosocial treatment is limited.
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, a moderate effect size is expected in the pre-post measures of parenting practices and the child target behavior for this study.
Study Type
Interventional
Enrollment (Actual)
27
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 Locations
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-
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Rio de Janeiro, Brazil, 22281-100
- D'Or Institute for Research
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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
4 years to 8 years (Child)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
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: Pilot testing of an education program promoting effective parenting habit
Parents will receive a series of 5 short videos via Whatsapp
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of videos viewed
Time Frame: 1 month
|
The number of videos viewed (minimum 0, maximum 5) to evaluate participant engagement.
|
1 month
|
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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.
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1 month
|
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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
|
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.
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1 month
|
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Proactive parenting
Time Frame: 1 month
|
Multidimensional Assessment of Parenting Scale (MAPS) Proactive Parenting sub-scale.
Parent ratings completed before and after the intervention using a 5-point scale.
Average across 6 items.
Higher scores indicate more frequent use of proactive parenting strategies.
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1 month
|
|
Use of positive reinforcement
Time Frame: 1 month
|
MAPS Positive Reinforcement sub-scale.
Parent ratings completed before and after the intervention using a 5-point scale.
Average across 4 items.
Higher scores indicate more frequent use of positive reinforcement strategies.
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1 month
|
|
Hostility toward child
Time Frame: 1 month
|
MAPS Hostility sub-scale.
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.
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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
|
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ODD symptoms
Time Frame: 1 month
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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
|
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Irritability
Time Frame: 1 month
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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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Paulo E Mattos, MD, PhD, D'Or Institute for Research and Eduaction
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)
November 1, 2021
Primary Completion (Actual)
October 24, 2022
Study Completion (Actual)
October 24, 2022
Study Registration Dates
First Submitted
September 27, 2021
First Submitted That Met QC Criteria
November 23, 2021
First Posted (Actual)
December 6, 2021
Study Record Updates
Last Update Posted (Actual)
April 25, 2023
Last Update Submitted That Met QC Criteria
April 24, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 50214221.6.0000.5249
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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