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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

Skills4Parenting+
Behavioral
Skills4Parenting+ has 6-8 weekly individual online sessions (50 min) + 8-week follow-up. First, an assessment session of parents' positive parenting skills (PPS), based on mother/father-child interaction observation. The following sessions aim to (1) promote parental reflective functioning, enhancing parents' understanding of the child´s problems, and (2) activate PPS to solve the child's problems. Written registers of problematic situations - in which the problems of the child occur, are analyzed (i.e., child's and parents' behaviors, thoughts, and feelings) (intersession activity) - are reflected upon, to understand and solve through PPS. PPS implementations are analyzed to understand the changes in the child and parent. Future situations and activation of appropriate PPS are anticipated, to solve potential upcoming problems of the child's, related to adversity. When the therapeutic goals have not been fully achieved, two additional sessions (total of 8 instead of 6), are added.
Waiting-list (nocebo)
Other intervention
Participants wait to receive the psychological intervention (Skills4Parenting+) for eight weeks, after the assessment session.

Treatment groups

60 Participants

are divided into 2 treatment groups

Group A: Immediate Intervention Group (IIG)Experimental treatment 1 intervention

Group B: Delayed Intervention Group (DIG)Other 1 intervention

Trial outcomes

Primary outcomes

1

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

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.

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).

2

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

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).

Time frame

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

3

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

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.

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)

4

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

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).

Time frame

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

Secondary outcomes

1

Change (Arm 1) "COVID-19 Pandemic Impact Questionnaire"

Questionnaire composed of 25 items that seek to assess the impact of covid-19 pandemic on the family, which can be answered by parents. Six items are scored on dichotomous scale, two items are scored on a 3-point scale, three items are scored on a 4-point scale, thirteen items are scored on a 5-point scale and one item is scored on a 6-point scale. It comprises five subscales: (1) health and covid-19 exposure, (2) family dynamics, (3) school, (4) social contact and (5) daily behaviors. The sum of the five subscales (with the exception of the prosocial behavior scale) allows the calculation of the total impact, which can vary between 0 and 86, with the impact being greater when the score is higher.

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).

2

Change (Arm 1) "Spence Preschool Anxiety Scale" (SPAS [10]; Portuguese version [11])

Questionnaire applied to parents, consisting of 28 items that assess problems related to 5 types of anxiety disorders present in preschool age: Generalized anxiety, social anxiety, separation anxiety, fear of physical damage and obsessive-compulsive disorder. Six additional items assess the presence of post-traumatic stress disorder symptoms. Each item is answered using a 5-point likert scale (0 = never to 4 = always). The partial results and the overall result are calculated by the sum of the responses to the items.

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).

3

Change (Arm 1) "Parental Practices Interview" (PPI [12]; Portuguese version [13])

Rigid and inconsistent Discipline Scale composed of 16 items, evaluated on a 7-point likert scale (1 = never to 7 = always). Higher scores are associated with more rigid and inconsistent parenting practices.

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).

4

Change (Arm 1) "Parental Reflective Functioning Questionnaire" (PRFQ [14]; Portuguese version [15])

PRFQ is a 18-item self-report multidimensional questionnaire, scored on a 7-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree). It was designed for parents of children aged 0 to 5 years to assess three key dimensions of PRF: an interest and curiosity in a child's mental states, the ability to recognize that a child's mental states may not be fully accessible, and difficulties with mentalization. The PRFQ comprises three subscales for assessing the abovementioned dimensions. The first subscale, Pre-Mentalizing Modes of Mental States (PM), Certainty about Mental States (CMS), Interest and Curiosity in Mental States (IC).

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).

Other outcomes

1

"Sociodemographic Questionnaire"

The Sociodemographic Questionnaire was used to collect sociodemographic information of the child and parents - such as gender, age, nationality, household members, socioeconomic level and schooling.

Time frame

1 time-point: Time 0 (1-2 weeks before 1st session; both arms).

2

Change (Arm 1) "Warwick-Edinburgh Mental Well-Being Scale" (WEMWBS [17]; Portuguese version [18])

Self-report scale composed of 14 items, scored on a 5-point likert scale (1= never to 5= always), to assess mental health and well-being. The minimum score is 14 points and the maximum score is 70 points, where the higher levels are associated with better mental well-being.

Time frame

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).

3

Change (Arm 2) "Warwick-Edinburgh Mental Well-Being Scale" (WEMWBS [17]; Portuguese version [18])

Self-report scale composed of 14 items, scored on a 5-point likert scale (1= never to 5= always), to assess mental health and well-being. The minimum score is 14 points and the maximum score is 70 points, where the higher levels are associated with better mental well-being.

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); Time 2 (8 weeks after last session).

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

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts