Clinical trial NCT05490745: Psychological Intervention for Child Mental Health Based on Parental Reflective Functioning to Enhance Positive Parenting
Official title: A Psychological Intervention for Children's Mental Health Problems or Disorders Based on Parental Reflective Functioning to Enhance Positive Parenting During Adverse Situations
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Externalizing Problems
Internalizing Problems
Keywords: Positive Parenting
Pre-school Children
Parents
Adversity
Psychological Problems
Parental Reflective Functioning
Psychological Disorders
Lead sponsor: University of Minho
Sponsor class: OTHER
Collaborators: name: Foundation for Science and Technology, Portugal
name: Psychology Research Center (CIPsi)
name: Psychology Association of the University of Minho (aPsi-UMinho)
name: ProChild CoLAB - The Collaborative Laboratory against child poverty and social exclusion
First posted: 2022-08-08
Enrollment: 60
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The interventional model is a simple two-arm RCT study (intervention vs. waiting-list), with 3 to 4 assessment waves (Time 0, Time 0+, Time 1, Time 2).

If the child is included in the study, they will be subject to a randomization process, being allocated, considering a sequence of random numbers generated by computer in a 1:1 ratio. In the randomization, half of the children are allocated to the IIG and the other half to the DIG.
Primary purpose: TREATMENT

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).

Detailed description: 1. Introduction Due to the negative effects of adversity on child mental health and development \[1\], this study proposes a validation of a psychological intervention, Skills4Parenting+, which aims to respond to the mental health needs of preschool children (3 to 6 years of age), in a preventive and remedial manner. This intervention is based on strong empirical evidence, such as Positive parenting from zero to three, the "Online Parenting Pro-Tips (OPPT)" \[2\], and parental reflective functioning \[3\].
2. Aims The aim of this project is to implement and study the effectiveness of a psychological intervention, Skills4Parenting+, for children with psychological problems or disorder and their families, associated with situations of adversity.
3. Methodology 3.1. Participants The target population of this project are children, aged between 3 and 6 years, including those attending pre-school of the public school system of the Municipality of Guimarães, and from aPsi - Psychology Association of the University of Minho, and their parents, who hold parental responsibilities. If validated, the procedures of Skills4Parenting+ can be replicated in other community contexts.

Recruitment of participants is done through the websites: + Citizenship (https://maiscidadania.cim-ave.pt/), CIPsi (https://www.psi.uminho.pt/pt/CIPsi), ProChild CoLAB (http: / /prochildcolab.pt), APsi-UMinho (https://apsi.uminho.pt) and Guimarães City Hall (https://www.cm-guimaraes.pt), as well as through the social networks of these institutions. In addition, posters, in various locations in the Municipality of Guimarães, roll-ups in formal events, postcards, delivered to children and families, and information about the project will be disseminated in local newspapers and radio in the Municipality of Guimarães.

Participants of (1) the screening procedure who access the + Citizenship platform (https://maiscidadania.cim-ave.pt/) or (2) of aPsi are all those who are self-referred to the private psychological services of aPsi, who hold parental responsibilities of at least one child under the conditions mentioned above, consent to participate in the study after being informed of the goals and procedures, who answer the screening questionnaires and who meet eligibility criteria.

3.2. Assessment Procedures The child's and their family's psychological assessment aim to: (1) validate the conditions necessary to implement a psychological intervention and (2) guide the child's psychological intervention.

If the report from the child's legal guardian indicates, during the screening, signs of psychological problems or disorder in the child, the child's legal guardian is invited to complete the psychological assessment through questionnaires.

The psychological assessment is carried out mostly online and lasts approximately 40 minutes. The questionnaires are answered (1) on the ProChild platform integrated with the + Citizenship platform and the Child Behavior Checklist (CBCL) is sent and returned by mail or (2) delivered in person or via mail, in paper, through aPsi's services.

After the child's legal guardian filled out the respective questionnaires, the screening and assessment data are analyzed and synthesized in an evaluation report.

In order to start the selection of children and families, the child's legal guardian is contacted by telephone to make an initial appointment. Posteriorly, if the child meets eligibility criteria, the materials necessary to carry out the evaluation at the first session and Informed Consent are delivered. In this consent, the child's legal guardian is asked to authorize a) their participation and the child's participation in the psychological intervention phase, b) filing in questionnaires for the orientation and monitoring of the psychological intervention, c) the realization of online sessions, if necessary, d) the videorecording of sessions and e) the data provided in the questionnaires. The child's legal guardian, who consent to subparagraphs a) and b), but not subparagraphs c), d), e), or f) may benefit from psychological intervention, if this is their will.

3.3. Intervention Procedures The first intervention session consists of a psychological assessment, which aims to, among others, validate the conditions necessary for the implementation of a psychological intervention. The session is scheduled and carried out with at least one of the child's legal guardians, after being informed about the goals and procedures of the psychological intervention and signing the Informed Consent. This assessment session lasts 45 to 60 minutes. After consent of the child's legal guardian is given, the session is videorecorded.

The structure of this session consists of a clinical interview, directed to the parents, considering the elements resulting from the evaluation report.

If the child meets any of the exclusion criteria, they are not followed up under this Program and are referred to an appropriate service. For children who are not participating in the study, an online session will be scheduled to return the results and justify the exclusion and/or referral. For children who are included in the intervention, a randomized controlled trial (RCT) will be carried out. According to it, the next session can be scheduled for the following week (IIG) or up to eight weeks after the first session (DIG). Participants who wait eight weeks are informed of the telephone line and e-mail, which they can use if necessary.

Psychological intervention is carried out by psychologists duly accredited by the Order of Portuguese Psychologists (OPP). It is carried out online or in person according to the updates of the General Directorate of Health (DGS) recommendations, regarding the evolution of the pandemic.

3.4. Randomization and Monitoring This project considers a simple two-arm RCT with the aim of randomly allocating participants into two intervention groups (IIG, DIG) in order to assess the effectiveness of a psychological intervention in comparison to a waiting list. This waiting list also facilitates the management of resources for the intervention provided in this project.

Monitoring is also carried out (through responses to evaluation questionnaires) with the aims of (1) monitoring the situation of the child and the family awaiting psychological intervention, (2) monitoring the response of the child and the family to the intervention and (3) evaluate the effectiveness of the intervention programs provided.

In case the child is part of the psychological intervention, Skills4Parenting+, it will be subjected to a randomization process, being allocated to one of the two groups, considering a sequence of random numbers generated by the computer. In this randomization, half of the children will be allocated to the psychological intervention (IIG), while the other half to a waiting list (DIG; after eight weeks).

After the last session (6th or 8th session) of the psychological intervention, an assessment is performed in order to verify if the child shows significant improvements or if he/she remains with psychopathological symptoms. After the conclusion of the assessment, cases that present at least two of the following elements, are referred to a targeted therapy, specific to the child's problems: (1) SDQ higher than the cutoff point (≥16), (2) indication of one or more trauma items in SPAS, and (3) continued impact of the effects of the adverse situation.

After the end of the psychological intervention, a follow-up session will be held 8 weeks later.

3.5. Data analysis procedures At least 60 children and their families will be recruited within the scope of the proposed psychological intervention. With n ≥ 30 in each group (2 groups), the effectiveness study of psychological intervention has a power of + 95% to detect medium-to-high effects (sample size calculator for SMART designs; 4,5).

If missing data is verified during descriptive analysis, the data will be imputated (if percentage of missing data is low) or removed (if percentage of missing data is high).

The data will be analyzed using the statistical software SPSS version 27. The normality of the data will be verified through the Kolmogorov-Smirnov test.

Descriptive analyzes and tests of differences between groups will be carried out (T-test or non-parametric equivalent).

To assess the effectiveness of the intervention, an ANOVA and MANOVA of repeated measures will be conducted with the different outcome variables, with an intra-subject factor (evaluation moments: Time 0, Time 0+, Time 1, Time 2) and with factor between groups (IIG, DIH).

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

Primary outcomes:
measure: 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).
measure: 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)
measure: 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)
measure: 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)
Secondary outcomes:
measure: Change (Arm 1) "COVID-19 Pandemic Impact Questionnaire"
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).
measure: Change (Arm 1) "Spence Preschool Anxiety Scale" (SPAS [10]; Portuguese version [11])
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).
measure: Change (Arm 1) "Parental Practices Interview" (PPI [12]; Portuguese version [13])
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).
measure: Change (Arm 1) "Parental Reflective Functioning Questionnaire" (PRFQ [14]; Portuguese version [15])
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).
measure: (Arm 1) "Brief Problem Monitor" (BPM [16]; Portuguese version in publication)
timeFrame: 1 time-point: Time 1 (1 week after last session).
measure: "Skills4Parenting+ Satisfaction Questionnaire"
timeFrame: 1 time-point: Time 1 (1 week after last session; both arms)
measure: Change (Arm 2) "COVID-19 Pandemic Impact Questionnaire"
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).
measure: Change (Arm 2) "Spence Preschool Anxiety Scale" (SPAS [10]; Portuguese version [11])
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).
measure: Change (Arm 2) "Parental Practices Interview" (PPI [12]; Portuguese version [13])
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).
measure: Change (Arm 2) "Parental Reflective Functioning Questionnaire" (PRFQ [14]; Portuguese version [15])
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).
measure: Change (Arm 2) "Brief Problem Monitor" (BPM [16]; Portuguese version in publication)
timeFrame: 2 time-points: Time 0+ (8 weeks after Time 0); and Time 1 (1 week after last session)
Other outcomes:
measure: "Sociodemographic Questionnaire"
timeFrame: 1 time-point: Time 0 (1-2 weeks before 1st session; both arms).
measure: Change (Arm 1) "Warwick-Edinburgh Mental Well-Being Scale" (WEMWBS [17]; Portuguese version [18])
timeFrame: 3 time-points: Time 0 (1-2 weeks before 1st session); Time 1 (1 week after last session); Time 2 (8 weeks after last session).
measure: Change (Arm 2) "Warwick-Edinburgh Mental Well-Being Scale" (WEMWBS [17]; Portuguese version [18])
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); Time 2 (8 weeks after last session).
Locations:
city: Braga
country: Portugal
facility: University of Minho
Study officials:
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