ADHDHabiteNCT05145920
Encouraging Positive Parenting Habits Through Digital Media
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, 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… Read more about this study
- Who is it for?
- Ages 4 to 8 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
- 27 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Nov 2021to 24 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- 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 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.
| Study group | Role | What they receive |
|---|---|---|
| Pilot testing of an education program promoting effective parenting habit | Experimental | Parents will receive a series of 5 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 (5)
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
Proactive parenting
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.
Measured: 1 month
Use of positive reinforcement
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.
Measured: 1 month
Hostility toward child
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.
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 posted6 Dec 2021
- Study start1 Nov 2021
- Primary completion24 Oct 2022
- Study completion24 Oct 2022
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
- 27 participants (actual)
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, Federal University of Rio Grande do Sul
- Responsible party
- Sponsor
- Investigators
- Paulo E Mattos, MD, PhD, Principal investigator, D'Or Institute for Research and Eduaction
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05145920
- Sponsor's protocol ID
- 50214221.6.0000.5249
- Acronym
- Habite
- Status last verified
- Apr 2023
- First submitted
- 27 Sep 2021
- Last updated
- 25 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Encouraging Positive Parenting Habits Through Digital Media
- ClinicalTrials.gov ID
- NCT05145920
- Acronym / sponsor ID
- Habite / 50214221.6.0000.5249
- Conditions
- ADHD
- Keywords
- ADHD, Parent Training, Treatment Access
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- D'Or Institute for Research and EducationUniversity, hospital or other
- Collaborators
- Okinawa Institute of Science and Technology Graduate University, Federal University of Rio Grande do Sul
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 24 Oct 2022 (actual)
- Study completion
- 24 Oct 2022 (actual)
- First posted
- 6 Dec 2021 (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, 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.
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 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 |
|---|---|---|
| Pilot 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 5 short videos via Whatsapp |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
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 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. | Behavioural | Pilot 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.
5 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
Proactive parenting
Time frame: 1 month
Use of positive reinforcement
Time frame: 1 month
Hostility toward child
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
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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. This study is not recruiting at the moment.
Paulo E Mattos, MD, PhD principal investigator
D'Or Institute for Research and Eduaction
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 1 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: finished, as of the sponsor's last update on 25 Apr 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 25 Apr 2023.