NCT05490745 Psychological Intervention for Child Mental Health Based on Parental Reflective Functioning to Enhance Positive Parenting
| NCT ID | NCT05490745 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Minho |
| Condition | Externalizing Problems |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2021-02-04 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2021-02-04 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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).
Eligibility Criteria
Inclusion Criteria: * Age between 3 and 6 years old, inclusive * Signaling in the screening (≥16 in the SDQ total scale) * CBCL (i.e., ≥60 on the Internalizing and/or Externalizing Scale) OR Parents report a high pandemic impact * Parental informed consent and commitment to the planned psychological intervention. * Parent is the child's legal guardian Exclusion Criteria: * Already receiving psychological intervention * Presence of psychological problems not related to an adverse situation or not likely to be monitored within the scope of the proposed intervention (for example, autism spectrum or intellectual development disorders or, domestic violence, neglect or abuse prior to the adverse situation); * Do not speak or understand Portuguese
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05490745 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, up to 6 Years, studying Externalizing Problems. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05490745 currently recruiting?
Yes, NCT05490745 is actively recruiting participants. Contact the research team at bbfi@psi.uminho.pt for enrollment information.
Where is the NCT05490745 trial being conducted?
This trial is being conducted at Braga, Portugal.
Who is sponsoring the NCT05490745 clinical trial?
NCT05490745 is sponsored by University of Minho. The trial plans to enroll 60 participants.