Psychiatric AspectsNCT07458438
Parents in Action: An Online Intervention Aimed at Parents' Well-being
A study testing Parapais em Ação in people with Psychiatric Aspects and Psychosocial Aspects, run by Federal University of Bahia at 1 site in Brazil.
Trial summary
The goal of this clinical trial is to learn if an online intervention improves well-being in low-income parents with children aged between 3 and 6 years. The main question[s] it aims to answer [is/are]: Does life satisfaction improves after the online intervention? Do stress, anxiety and depression symptoms diminish… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Psychiatric Aspects, Psychosocial Aspects
- What is being tested?
- Parapais em Ação
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jun 2024to 31 Dec 2027
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- parents of children between 3 and 6 years of age
- parents must live with the child
- child must attend public school
Who cannot join
- parents under 19 years of age
- child with chronic disease or genetic syndromes
- lack of access to the internet or a digital device
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
CMEI União Bica do Rio
Salvador, Estado de Bahia, 41720-000
Amanda Reis, Graduation, 55(71)991142151, cmei-uniaobocadorio@salvador.ba.gov.br
Nathaly Gonçalves, MBA
About this study
Official title: Evaluation of an Online Intervention to Promote Parental Well-being and Child Development
The goal of this clinical trial is to learn if an online intervention improves well-being in low-income parents with children aged between 3 and 6 years. The main question[s] it aims to answer [is/are]:
- Does life satisfaction improves after the online intervention?
- Do stress, anxiety and depression symptoms diminish after the online intervention? Researchers will compare parents who took the online intervention with parents who did not to see if the intervention makes parents feel more satisfied with life and less stressed, anxious and depressed.
Read more
Participants will be interviewed about their own well-being, mental health and parenting practices and about their children's behavior and screen use before taking the online intervention.
During the intervention, parents will watch videos, answer quizzes and do simple activities at home.
After the online intervention, parents will be interviewed again about their own well-being, mental health and parenting practices and about their children's behavior and screen use before taking the online intervention.
Read the detailed description
Researchers will compare parents who took the online intervention with parents who did not to see if the intervention makes parents feel more satisfied with life and less stressed, anxious and depressed. The comparison will be based on tests that measure the life satisfaction, positive and negative emotions, stress, anxiety and depression according to parents report. Parents will respond to these tests during an online interview before starting the online intervention. During the interview they will also report on their parenting practices and their children's development and screen use. The interview lasts between 45 and 60 minutes.
During the 10 weeks of intervention, parents will watch videos, answer quizzes and do simple activities at home. They will spend between 30 and 45 minutes doing the online and home activities each week. Fifty percent of the parents who will undergo the intervention will also have a weekly video call with a psychologist to clarify doubts and solve difficulties found in the online activities.
After the online intervention, parents will be interviewed again about their own well-being, mental health and parenting practices and about their children's behavior and screen use. The same interview procedures held before the intervention will be repeated after the intervention, when parents who underwent the online program will also respond a questionnaire about their satisfaction with the intervention. For parents who did not undergo the intervention, the last interview will happen eleven weeks after the first interview. After the last interview, parents who did not undergo the intervention before, will be able to take the intervention if they want to do so.
- Conditions
- Psychiatric Aspects, Psychosocial Aspects
- Being tested
- Parapais em Ação
- Keywords
- parenthood, well-being, mental health, early childhood development
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parapais em AçãoBehavioural
Parapais em Ação is a 10-week online program aimed at enhancing parents' well-being and mental health through psycho-educational videos, quizzes, practices of new skills. It was especially developed for Brazilian parents with children between 3 and 6 years of age.
| Study group | Role | What they receive |
|---|---|---|
| Self-administered | Experimental | Participants in this arm will undergo the self-administered version of the online intervention Receives: Behavioral: Parapais em Ação |
| Mixed | Experimental | Participants in this arm will undergo the mixed version of the online intervention that includes weekly online meetings with a psychologist Receives: Behavioral: Parapais em Ação |
| wait list | No intervention | Participants in this arm will undergo the self-administered version only after the posttest |
What is being measured
The primary outcome is the main question the study is designed to answer.
PANAS - Positive and Negative Affects Scale
Evaluates subjective well-being emotional dimensions. The PANAS is a self-report instrument composed of 10 items that assess positive affect and 10 items that assess negative affect. The items consist of adjectives and are answered on a five-point Likert scale corresponding to how much a person feels the emotions described by the adjectives: (1) not at all; (2) a little; (3) moderately; (4) quite a lot; and (5) extremely. The sum of the scores of all items relating to each construct provides the total score for positive and negative affect. Some examples of items are: a) distressed; b) excited; c) inspired; and d) irritated.
Measured: From enrollment to one week after the end of the intervention.
LSS - Life Satisfaction Scale
Assesses the cognitive dimension of subjective well-being. The instrument consists of five items that evaluate an individual's level of satisfaction with their living conditions. Each item is answered on a seven-point Likert scale ranging from (1) strongly disagree to (7) strongly agree. The sum of the scores for all items provides the total life satisfaction score. Some examples of items are: a) my life is close to my ideal; and b) if I could live my life again, I wouldn't change almost anything.
Measured: From enrollment to one week after the end of the intervention.
Secondary outcomes (1)
DASS-21 - Depression, Anxiety and Stress Scale
It assesses symptoms of depression, anxiety, and stress. The instrument consists of 21 items, divided into three factors (Depression: 3, 5, 10, 13, 16, 17, 21; Anxiety: 2, 4, 7, 9, 15, 19, 20; and Stress: 1, 6, 8, 11, 12, 14, 18). The items are answered using a four-point Likert scale, ranging from 0 (not at all applicable) to 3 (applied very much or most of the time), and the sum of the scores allows classification in each of the factors as normal, mild, moderate, severe, and extremely severe.
Measured: From enrollment to one week after the end of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study start1 Jun 2024
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychiatric AspectsStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three groups will be compared: self-administered online intervention, mixed online intervention and wait list
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Bahia
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Principal investigator, Patrícia Alvarenga, Federal University of Bahia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07458438
- Sponsor's protocol ID
- CNPq30667020216
- Status last verified
- Mar 2026
- First submitted
- 4 Mar 2026
- Last updated
- 11 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The ethical statement did not include permission to share participants' data.
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Online Intervention to Promote Parental Well-being and Child Development
- ClinicalTrials.gov ID
- NCT07458438
- Acronym / sponsor ID
- CNPq30667020216
- Conditions
- Psychiatric Aspects, Psychosocial Aspects
- Keywords
- parenthood, well-being, mental health, early childhood development
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Federal University of BahiaUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 9 Mar 2026 (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.
The goal of this clinical trial is to learn if an online intervention improves well-being in low-income parents with children aged between 3 and 6 years. The main question[s] it aims to answer [is/are]:
- Does life satisfaction improves after the online intervention?
- Do stress, anxiety and depression symptoms diminish after the online intervention? Researchers will compare parents who took the online intervention with parents who did not to see if the intervention makes parents feel more satisfied with life and less stressed, anxious and depressed.
Participants will be interviewed about their own well-being, mental health and parenting practices and about their children's behavior and screen use before taking the online intervention.
During the intervention, parents will watch videos, answer quizzes and do simple activities at home.
After the online intervention, parents will be interviewed again about their own well-being, mental health and parenting practices and about their children's behavior and screen use before taking the online intervention.
Detailed description
Researchers will compare parents who took the online intervention with parents who did not to see if the intervention makes parents feel more satisfied with life and less stressed, anxious and depressed. The comparison will be based on tests that measure the life satisfaction, positive and negative emotions, stress, anxiety and depression according to parents report. Parents will respond to these tests during an online interview before starting the online intervention. During the interview they will also report on their parenting practices and their children's development and screen use. The interview lasts between 45 and 60 minutes.
During the 10 weeks of intervention, parents will watch videos, answer quizzes and do simple activities at home. They will spend between 30 and 45 minutes doing the online and home activities each week. Fifty percent of the parents who will undergo the intervention will also have a weekly video call with a psychologist to clarify doubts and solve difficulties found in the online activities.
After the online intervention, parents will be interviewed again about their own well-being, mental health and parenting practices and about their children's behavior and screen use. The same interview procedures held before the intervention will be repeated after the intervention, when parents who underwent the online program will also respond a questionnaire about their satisfaction with the intervention. For parents who did not undergo the intervention, the last interview will happen eleven weeks after the first interview. After the last interview, parents who did not undergo the intervention before, will be able to take the intervention if they want to do so.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 3
- Model description
- Three groups will be compared: self-administered online intervention, mixed online intervention and wait list
| Arm | Type | Receives |
|---|---|---|
| Self-administered | Experimental | Behavioral: Parapais em AçãoParticipants in this arm will undergo the self-administered version of the online intervention |
| Mixed | Experimental | Behavioral: Parapais em AçãoParticipants in this arm will undergo the mixed version of the online intervention that includes weekly online meetings with a psychologist |
| wait list | No intervention | –Participants in this arm will undergo the self-administered version only after the posttest |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- parents of children between 3 and 6 years of age
- parents must live with the child
- child must attend public school
Key exclusion criteria (3 listed)
- parents under 19 years of age
- child with chronic disease or genetic syndromes
- lack of access to the internet or a digital device
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 |
|---|---|---|
| Parapais em AçãoParapais em Ação is a 10-week online program aimed at enhancing parents' well-being and mental health through psycho-educational videos, quizzes, practices of new skills. It was especially developed for Brazilian parents with children between 3 and 6 years of age. | Behavioural | Mixed, Self-administered |
Primary outcome
PANAS - Positive and Negative Affects Scale
Time frame: From enrollment to one week after the end of the intervention.
Evaluates subjective well-being emotional dimensions. The PANAS is a self-report instrument composed of 10 items that assess positive affect and 10 items that assess negative affect. The items consist of adjectives and are answered on a five-point Likert scale corresponding to how much a person feels the emotions described by the adjectives: (1) not at all; (2) a little; (3) moderately; (4) quite a lot; and (5) extremely. The sum of the scores of all items relating to each construct provides the total score for positive and negative affect. Some examples of items are: a) distressed; b) excited; c) inspired; and d) irritated.
LSS - Life Satisfaction Scale
Time frame: From enrollment to one week after the end of the intervention.
Assesses the cognitive dimension of subjective well-being. The instrument consists of five items that evaluate an individual's level of satisfaction with their living conditions. Each item is answered on a seven-point Likert scale ranging from (1) strongly disagree to (7) strongly agree. The sum of the scores for all items provides the total life satisfaction score. Some examples of items are: a) my life is close to my ideal; and b) if I could live my life again, I wouldn't change almost anything.
1 secondary outcome
DASS-21 - Depression, Anxiety and Stress Scale
Time frame: From enrollment to one week after the end of the intervention
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 11 Mar 2026.
- This is the website of the research lab that is doing the research. The website has a short video (in Portuguese) about the intervention.Link provided by the sponsor.
- This Instagram profile has videos (in Portuguese) about the researchLink provided by the sponsor.
- Individual participant dataSharing planned: No. The ethical statement did not include permission to share participants' data.
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 Parapais em Ação in people with Psychiatric Aspects and Psychosocial Aspects, run by Federal University of Bahia 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 3 inclusion and 3 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 11 Mar 2026. 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 Patrícia Alvarenga, Ph.D. (55(71)999594437, palvarenga66@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PANAS - Positive and Negative Affects Scale (time frame: From enrollment to one week after the end of the intervention.). The study lists 2 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 11 Mar 2026.