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临床试验/NCT07458438
NCT07458438招募中不适用

Evaluation of an Online Intervention to Promote Parental Well-being and Child Development

Federal University of Bahia1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2024年6月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
150
试验地点
1
主要终点
PANAS - Positive and Negative Affects Scale

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Care Provider)

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • parents of children between 3 and 6 years of age
  • parents must live with the child
  • child must attend public school

排除标准

  • parents under 19 years of age
  • child with chronic disease or genetic syndromes
  • lack of access to the internet or a digital device

研究组 & 干预措施

Mixed

Experimental

Participants in this arm will undergo the mixed version of the online intervention that includes weekly online meetings with a psychologist

干预措施: Parapais em Ação (Behavioral)

wait list

No Intervention

Participants in this arm will undergo the self-administered version only after the posttest

Self-administered

Experimental

Participants in this arm will undergo the self-administered version of the online intervention

干预措施: Parapais em Ação (Behavioral)

结局指标

主要结局

PANAS - Positive and Negative Affects Scale

时间窗: 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

时间窗: 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.

次要结局

  • DASS-21 - Depression, Anxiety and Stress Scale(From enrollment to one week after the end of the intervention)

研究者

发起方
Federal University of Bahia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Patrícia Alvarenga

Principal Investigator

Federal University of Bahia

研究点 (1)

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