ADHDHABITENCT06305429
Encouraging Positive Parenting Habits
A study testing HabitE (effective parenting habit) program (in Brazilian Portuguese) in people with ADHD, run by D'Or Institute for Research and Education at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 10 years
- Conditions the study is for
- ADHD
- What is being tested?
- HabitE (effective parenting habit) program (in Brazilian Portuguese)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jun 2024to Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Parents of children aged from 4 to 10 years old
- Parents experiencing behavior difficulties with daily transition routines (parent-report).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Instituto D'or de Pesquisa e Ensino (IDOR)
Brazil
About this study
Official title: 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.
Read the 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.
- Conditions
- ADHD
- Being tested
- HabitE (effective parenting habit) program (in Brazilian Portuguese)
- Keywords
- ADHD, Parent Training, Treatment Access
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HabitE (effective parenting habit) program (in Brazilian Portuguese)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Feasibility testing of an education program promoting effective parenting habit | Experimental | Parents will receive a series of 6 short videos via Whatsapp Receives: Behavioral: HabitE (effective parenting habit) program (in Brazilian Portuguese) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of videos viewed
The number of videos viewed (minimum 0, maximum 5) to evaluate participant engagement
Measured: 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.
Measured: 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.
Measured: 1 month
Secondary outcomes (6)
Parent-rated child's difficulties with daily transitions
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.
Measured: 1 month
Parent-rated child's impairment related to transition difficulties
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.
Measured: 1 month
Inconsistent parenting
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.
Measured: 1 month
Use of physical control
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.
Measured: 1 month
Hostility toward child
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.
Measured: 1 month
Parent Stress
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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start1 Jun 2024
- Primary completionJun 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open, single-group trial
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- D'Or Institute for Research and Education
- Sponsor type
- University, hospital or other
- Collaborators
- Okinawa Institute of Science and Technology Graduate University
- Responsible party
- Principal investigator, Paulo Eduardo Luiz de Mattos, D'Or Institute for Research and Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06305429
- Sponsor's protocol ID
- HABITE
- Acronym
- HABITE
- Status last verified
- Oct 2024
- First submitted
- 5 Mar 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Encouraging Positive Parenting Habits Through Digital Media: Feasibility Study
- ClinicalTrials.gov ID
- NCT06305429
- Acronym / sponsor ID
- HABITE / HABITE
- Conditions
- ADHD
- Keywords
- ADHD, Parent Training, Treatment Access
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- D'Or Institute for Research and EducationUniversity, hospital or other
- Collaborators
- Okinawa Institute of Science and Technology Graduate University
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 12 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open, single-group trial
| Arm | Type | Receives |
|---|---|---|
| Feasibility testing of an education program promoting effective parenting habit | Experimental | Behavioral: HabitE (effective parenting habit) program (in Brazilian Portuguese)Parents will receive a series of 6 short videos via Whatsapp |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Parents of children aged from 4 to 10 years old
- Parents experiencing behavior difficulties with daily transition routines (parent-report).
Key exclusion criteria (2 listed)
- Parents that do not have the children living with them at least 5 days per week every week;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Feasibility testing of an education program promoting effective parenting habit |
Primary outcome
Number of videos viewed
Time frame: 1 month
The number of videos viewed (minimum 0, maximum 5) to evaluate participant engagement
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.
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.
6 secondary outcomes
Parent-rated child's difficulties with daily transitions
Time frame: 1 month
Parent-rated child's impairment related to transition difficulties
Time frame: 1 month
Inconsistent parenting
Time frame: 1 month
Use of physical control
Time frame: 1 month
Hostility toward child
Time frame: 1 month
Parent Stress
Time frame: 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HabitE (effective parenting habit) program (in Brazilian Portuguese) in people with ADHD, run by D'Or Institute for Research and Education at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Camila Bernardes (+5521966834545, camila.bfaria@idor.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of videos viewed (time frame: 1 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.