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| Name | Class |
|---|---|
| Conselho Nacional de Desenvolvimento CientÃfico e Tecnológico | OTHER_GOV |
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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]:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Self-administered | Experimental | Participants in this arm will undergo the self-administered version of the online intervention |
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| Mixed | Experimental | Participants in this arm will undergo the mixed version of the online intervention that includes weekly online meetings with a psychologist |
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| wait list | No Intervention | Participants in this arm will undergo the self-administered version only after the posttest |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Parapais em Ação | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | From enrollment to one week after the end of the intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| PAFAS - Parenting and Family Adjustment Scales | 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). |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| PatrÃcia Alvarenga, Ph.D. | Contact | 55(71)999594437 | palvarenga66@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CMEI União Bica do Rio | Recruiting | Salvador | Estado de Bahia | 41720-000 | Brazil |
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| Label | URL |
|---|---|
| This is the website of the research lab that is doing the research. The website has a short video (in Portuguese) about the intervention. | View source |
| This Instagram profile has videos (in Portuguese) about the research | View source |
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The ethical statement did not include permission to share participants' data.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Apr 24, 2024 | Mar 4, 2026 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D010549 | Personal Satisfaction |
| D001519 | Behavior |
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Three groups will be compared: self-administered online intervention, mixed online intervention and wait list
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| From enrollment to one week after the end of the intervention |
| From enrollment to one week after the end of the intervention |