- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07458438
Parents in Action: An Online Intervention Aimed at Parents' Well-being
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.
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Patrícia Alvarenga, Ph.D.
- Phone Number: 55(71)999594437
- Email: palvarenga66@gmail.com
Study Locations
-
-
Estado de Bahia
-
Salvador, Estado de Bahia, Brazil, 41720-000
- Recruiting
- CMEI União Bica do Rio
-
Contact:
- Amanda Reis, Graduation
- Phone Number: 55(71)991142151
- Email: cmei-uniaobocadorio@salvador.ba.gov.br
-
Sub-Investigator:
- Nathaly Gonçalves, MBA
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- parents of children between 3 and 6 years of age
- parents must live with the child
- child must attend public school
Exclusion Criteria:
- parents under 19 years of age
- child with chronic disease or genetic syndromes
- lack of access to the internet or a digital device
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Self-administered
Participants in this arm will undergo the self-administered version of the online intervention
|
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.
|
|
Experimental: Mixed
Participants in this arm will undergo the mixed version of the online intervention that includes weekly online meetings with a psychologist
|
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.
|
|
No Intervention: wait list
Participants in this arm will undergo the self-administered version only after the posttest
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
From enrollment to one week after the end of the intervention.
|
|
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.
|
From enrollment to one week after the end of the intervention.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
DASS-21 - Depression, Anxiety and Stress Scale
Time Frame: From enrollment to one week after the end of the intervention
|
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.
|
From enrollment to one week after the end of the intervention
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PAFAS - Parenting and Family Adjustment Scales
Time Frame: From enrollment to one week after the end of the intervention
|
The PAFAS investigates parenting practices and parental and family adjustment, and is geared toward this purpose.
It was developed with 40 items, containing a 28-item parenting scale covering two domains, including "parenting practices" (17 items) and "parent-child relationship" (11 items), and a 12-item family adjustment scale with three domains, composed of "parental emotional adjustment" (5 items), "positive family relationships" (4 items), and "parental teamwork" (3 items).
|
From enrollment to one week after the end of the intervention
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CNPq30667020216
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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