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
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