NCT07458438

Brief 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 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
17mo left

Started Jun 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress61%
Jun 2024Dec 2027

Study Start

First participant enrolled

June 1, 2024

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

March 4, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 9, 2026

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

March 11, 2026

Status Verified

March 1, 2026

Enrollment Period

3.2 years

First QC Date

March 4, 2026

Last Update Submit

March 9, 2026

Conditions

Keywords

parenthoodwell-beingmental healthearly childhood development

Outcome Measures

Primary Outcomes (2)

  • 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.

Secondary Outcomes (1)

  • DASS-21 - Depression, Anxiety and Stress Scale

    From enrollment to one week after the end of the intervention

Other Outcomes (1)

  • PAFAS - Parenting and Family Adjustment Scales

    From enrollment to one week after the end of the intervention

Study Arms (3)

Self-administered

EXPERIMENTAL

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

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

Behavioral: Parapais em Ação

wait list

NO INTERVENTION

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

Interventions

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.

MixedSelf-administered

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CMEI União Bica do Rio

Salvador, Estado de Bahia, 41720-000, Brazil

RECRUITING

Related Links

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Central Study Contacts

Patrícia Alvarenga, Ph.D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Three groups will be compared: self-administered online intervention, mixed online intervention and wait list
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 4, 2026

First Posted

March 9, 2026

Study Start

June 1, 2024

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

March 11, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

The ethical statement did not include permission to share participants' data.

Locations