RecruitingNot Applicable

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

Portugal60 participantsStarted 2021-02-04

Plain-language 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).

Who can participate

Age range

3 Years – 6 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change (Arm 1) "Strengths & Difficulties Questionnaire" (SDQ [6]; Portuguese version [7])

Timeframe: 3 time-points: Time 0 (1-2 weeks before 1st session); Time 1 (1 week after last session); and Time 2 (8 weeks after last session).

Change (Arm 1) "Child Behavior Checklist 1½-5 "(CBCL [8]; Portuguese version [9])

Timeframe: 2 time-points: Time 0 (1-2 weeks before 1st session); and Time 2 (8 weeks after last session)

Change (Arm 2) "Strengths & Difficulties Questionnaire" (SDQ [6]; Portuguese version [7])

Timeframe: 4 time-points: Time 0 (1-2 weeks before 1st session); Time 0+ (8 weeks after Time 0); Time 1 (1 week after last session); and Time 2 (8 weeks after last session)

Change (Arm 2) "Child Behavior Checklist 1½-5 "(CBCL [8]; Portuguese version [9])

Timeframe: 2 time-points: Time 0 (1-2 weeks before 1st session); and Time 2 (8 weeks after last session)

Trial details

NCT IDNCT05490745

SponsorUniversity of Minho

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-31

Contact for this trial

Bárbara Figueiredo

939993937 bbfi@psi.uminho.pt

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