A Psychological Intervention for Children's Mental Health Problems or Disorders Based on Parental Reflective Functioning to Enhance Positive Parenting During Adverse Situations
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Minho
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Change (Arm 2) "Strengths & Difficulties Questionnaire" (SDQ [6]; Portuguese version [7])
Study Overview
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
- 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].
- 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.
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 3 Years to 6 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Immediate Intervention Group (IIG)
Participants receive initially one session for psychological assessment. At the end of the session, the second session is scheduled for the following week, where feedback about the assessment will be provided. If in the second session participants agree to proceed with the psychological intervention, then the remaining 4-6 sessions of Skills4Parenting+ are conducted.
Intervention: Skills4Parenting+ (Behavioral)
Delayed Intervention Group (DIG)
Waiting-list Comparator (nocebo): Participants initially receive one session for psychological assessment. At the end of the session, participants are informed that they will be contacted to schedule the second session, where feedback about the assessment will be provided. Participants are contacted during the same week, to schedule the second session 8 weeks after the first session. If in the second session participants agree to proceed with the psychological intervention, then the remaining 4-6 sessions of Skills4Parenting+ are conducted.
Intervention: Waiting-list (nocebo) (Other)
Outcomes
Primary Outcomes
Change (Arm 2) "Strengths & Difficulties Questionnaire" (SDQ [6]; Portuguese version [7])
Time Frame: 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)
Questionnaire with 25 items that seek to assess emotional and behavioral problems, which can be answered by parents and teachers of children from 3 to 16 years old. In this study, only the version for parents is used. The items are scored on a 3-point scale (0 = "Not true", 1 = "It is a bit true" and "2 = It is very true"). It comprises five subscales: (1) emotional symptoms, (2) conduct problems, (3) hyperactivity, (4) peer problems and (5) prosocial behavior. The sum of the first four subscales (with the exception of the prosocial behavior scale) allows the calculation of the total of difficulties, which can vary between 0 and 40. In addition to the 25 items, 5 additional items are applied to assess the impact of the reported problems in the child's life. The cutoff point of the questionnaire is 16 or more points, on the total scale, indicating clinical level of the child's emotional and behavioral problems.
Change (Arm 1) "Strengths & Difficulties Questionnaire" (SDQ [6]; Portuguese version [7])
Time Frame: 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).
Questionnaire with 25 items that seek to assess emotional and behavioral problems, which can be answered by parents and teachers of children from 3 to 16 years old. In this study, only the version for parents is used. The items are scored on a 3-point scale (0 = "Not true", 1 = "It is a bit true" and "2 = It is very true"). It comprises five subscales: (1) emotional symptoms, (2) conduct problems, (3) hyperactivity, (4) peer problems and (5) prosocial behavior. The sum of the first four subscales (with the exception of the prosocial behavior scale) allows the calculation of the total of difficulties, which can vary between 0 and 40. In addition to the 25 items, 5 additional items are applied to assess the impact of the reported problems in the child's life. The cutoff point of the questionnaire is 16 or more points, on the total scale, indicating clinical level of the child's emotional and behavioral problems.
Change (Arm 2) "Child Behavior Checklist 1½-5 "(CBCL [8]; Portuguese version [9])
Time Frame: 2 time-points: Time 0 (1-2 weeks before 1st session); and Time 2 (8 weeks after last session)
Questionnaire composed of 113 items that assess internalizing (i.e., anxiety/depression, isolation, somatic complaints), externalizing (i.e., delinquent behavior, aggressive behavior), social, thinking and attention problems of the child. Each item is answered on a 3-point likert scale (0 = statement is not true to 2 = statement that is very true or often true).
Change (Arm 1) "Child Behavior Checklist 1½-5 "(CBCL [8]; Portuguese version [9])
Time Frame: 2 time-points: Time 0 (1-2 weeks before 1st session); and Time 2 (8 weeks after last session)
Questionnaire composed of 113 items that assess internalizing (i.e., anxiety/depression, isolation, somatic complaints), externalizing (i.e., delinquent behavior, aggressive behavior), social, thinking and attention problems of the child. Each item is answered on a 3-point likert scale (0 = statement is not true to 2 = statement that is very true or often true).
Secondary Outcomes
- Change (Arm 1) "Parental Practices Interview" (PPI [12]; Portuguese version [13])(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).)
- "Skills4Parenting+ Satisfaction Questionnaire"(1 time-point: Time 1 (1 week after last session; both arms))
- Change (Arm 1) "Parental Reflective Functioning Questionnaire" (PRFQ [14]; Portuguese version [15])(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 2) "Parental Practices Interview" (PPI [12]; Portuguese version [13])(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 1) "COVID-19 Pandemic Impact Questionnaire"(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).)
- (Arm 1) "Brief Problem Monitor" (BPM [16]; Portuguese version in publication)(1 time-point: Time 1 (1 week after last session).)
- Change (Arm 1) "Spence Preschool Anxiety Scale" (SPAS [10]; Portuguese version [11])(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 2) "Parental Reflective Functioning Questionnaire" (PRFQ [14]; Portuguese version [15])(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) "COVID-19 Pandemic Impact Questionnaire"(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) "Spence Preschool Anxiety Scale" (SPAS [10]; Portuguese version [11])(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) "Brief Problem Monitor" (BPM [16]; Portuguese version in publication)(2 time-points: Time 0+ (8 weeks after Time 0); and Time 1 (1 week after last session))
Investigators
Bárbara Figueiredo
Associate Professor with Aggregation
University of Minho