Clinical Trial

Psychological Intervention for Child Mental Health Based on Parental Reflective Functioning to Enhance Positive Parenting

Study acronym: SK4Parenting+
Recruiting
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Record status
This record was last updated April 8, 2025 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.
Summary
In this study we aim to verify the effectiveness of a psychological intervention for preschool children, 3 to 6 years of age, with psychological problems or disorders, arising from adversity, Skills4Parenting+. Skills4Parenting+, with 6 to 8 weekly sessions, aims to treat the child's psychological problems or disorders, based on parental reflective functioning, to activate and develop parents' positive parenting skills, in response to situations of adversity. To assess the effectiveness, we plan to conduct an a simple two-arm RCT study, where children are randomly allocated to an immediate intervention group (IIG) or a delayed intervention group (DIG). The IIG will be assessed at 3 time-points: Time 0 (pre-test: before the 1st session); Time 1 (post-test: after the last session) and Time 2 (follow-up: 8 weeks after the last session). The DIG will be assessed at 4 time-points: Time 0 (pre-test 1: before the 1st session); Time 0+ (pre-test 2: 8 weeks after the 1st session); Time 1 (post-test: after the last session) and Time 2 (follow up: 8 weeks after the last session). A time period of 8 weeks will be maintained between each time point. In this study, we expect the (1) psychological intervention to significantly diminish the child's psychological problems or disorders (from pretest to posttest); (2) parental reflective functioning will mediate the effect of the psychological intervention on child's psychological problems or disorders; (3) the children from IIG will demonstrate a significant improvement in their mental health, in comparison to the children from the DIG; and (4) for the effects of the psychological intervention (i.e., improvement in the child's mental health) to be maintained in the medium-term (from posttest to follow-up).
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2022-08-04; most recent amendment 2025-04-04.
Trial Details
NCT Number NCT05490745
Lead Sponsor University of Minho
Collaborators: Foundation for Science and Technology, Portugal, Psychology Research Center (CIPsi), Psychology Association of the University of Minho (aPsi-UMinho), ProChild CoLAB - The Collaborative Laboratory against child poverty and social exclusion
Conditions Externalizing Problems, Internalizing Problems
Enrollment 60 participants
Start Date 2021-02-04
Primary Completion 2025-12-31 (estimated)
Study Completion 2025-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-04-08