About this trial
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
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Skills4Parenting+
- Waiting-list (nocebo)
Treatment groups
Sponsors and collaborators
University of Minho
Lead sponsor
Foundation for Science and Technology, Portugal
Collaborator
Psychology Research Center (CIPsi)
Collaborator
Psychology Association of the University of Minho (aPsi-UMinho)
Collaborator
ProChild CoLAB - The Collaborative Laboratory against child poverty and social exclusion
Collaborator