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

NCT05490745 | Recruiting DMC

• 2 other identifiers: CEICSH 106/2020CIPSI-VC-2020-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Externalizing Problems; Internalizing Problems

Keywords

Positive Parenting; Pre-school Children; Parents; Adversity; Psychological Problems; Parental Reflective Functioning; Psychological Disorders

Outcome Measures

Primary Outcomes (4)

• 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.

  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])

  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).

  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])

  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.

  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])

  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).

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

Secondary Outcomes (11)

• 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).

• 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 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).

• 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).

• (Arm 1) "Brief Problem Monitor" (BPM [16]; Portuguese version in publication)

  1 time-point: Time 1 (1 week after last session).

Other Outcomes (3)

• "Sociodemographic Questionnaire"

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

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

  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).

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

  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).

Study Arms (2)

Immediate Intervention Group (IIG)

EXPERIMENTAL

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.

Behavioral: Skills4Parenting+

Delayed Intervention Group (DIG)

OTHER

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.

Other: Waiting-list (nocebo)

Interventions

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.

Immediate Intervention Group (IIG)

Waiting-list (nocebo) OTHER

Participants wait to receive the psychological intervention (Skills4Parenting+) for eight weeks, after the assessment session.

Delayed Intervention Group (DIG)

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minho: lead
• 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

Study Sites (1)

University of Minho

Braga, Braga District, 4710-057, Portugal

RECRUITING

Related Publications (18)

• Ravens-Sieberer U, Kaman A, Erhart M, Devine J, Schlack R, Otto C. Impact of the COVID-19 pandemic on quality of life and mental health in children and adolescents in Germany. Eur Child Adolesc Psychiatry. 2022 Jun;31(6):879-889. doi: 10.1007/s00787-021-01726-5. Epub 2021 Jan 25.

  PMID: 33492480 BACKGROUND

• [2] Riegler, L. J., Raj, S. P., Moscato, E. L., Narad, M. E., Kincaid, A., & Wade, S. L. (2020). Pilot trial of a telepsychotherapy parenting skills intervention for veteran families: Implications for managing parenting stress during COVID-19. Journal of Psychotherapy Integration, 30(2), 290. doi: 10.1037/int0000220

  BACKGROUND

• Ensink K, Borelli JL, Roy J, Normandin L, Slade A, Fonagy P. Costs of Not Getting to Know You: Lower Levels of Parental Reflective Functioning Confer Risk for Maternal Insensitivity and Insecure Infant Attachment. Infancy. 2019 Mar;24(2):210-227. doi: 10.1111/infa.12263. Epub 2018 Oct 11.

  PMID: 32677198 BACKGROUND

• [4] Crivello, A.I., Levy, J.A., & Murphy, S.A. 2007a. Evaluation of Sample Size Formulae for Developing Adaptive Treatment Strategies Using a SMART Design. Tech. rept. No. 07-81. University Park, PA: The Pennsylvania State University, The Methodology Center.

  BACKGROUND

• [5] Crivello, A.I., Levy, J.A., & Murphy, S.A. 2007b. Statistical Methodology for a SMART Design in the Development of Adaptive Treatment Strategies. Tech. rept. No. 07-82. University Park, PA: The Pennsylvania State University, The Methodology Center.

  BACKGROUND

• Goodman R. Psychometric properties of the strengths and difficulties questionnaire. J Am Acad Child Adolesc Psychiatry. 2001 Nov;40(11):1337-45. doi: 10.1097/00004583-200111000-00015.

  PMID: 11699809 BACKGROUND

• [7] Fleitlich, B., Loureiro, M., Fonseca, A., & Gaspar, F. (2005). Questionário de capacidades e dificuldades (SDQ-Por)[Strengths and Difficulties Questionnaire, Portuguese version]. Retrived from http://www. sdqinfo. org.

  BACKGROUND

• [8] Achenbach, T. M., & Rescorla, L. A. (2000). Manual for the ASEBA preschool forms and profiles (Vol. 30). Burlington, VT: University of Vermont, Research center for children, youth, & families.

  BACKGROUND

• [9] Achenbach, T. M., Rescorla, L. A., Dias, P., Ramalho, V., Lima, V. S., Machado, B. C., & Gonçalves, M. (2014). Manual do sistema de avaliação empiricamente validado (ASEBA): Um sistema integrado de avaliação com múltiplos informadores. Manual do período pré-escolar e do período escolar. Braga: Psiquilibrios Edições

  BACKGROUND

• Spence SH, Rapee R, McDonald C, Ingram M. The structure of anxiety symptoms among preschoolers. Behav Res Ther. 2001 Nov;39(11):1293-316. doi: 10.1016/s0005-7967(00)00098-x.

  PMID: 11686265 BACKGROUND

• [11] Almeida, J. P., & Viana, V. (2013). Adaptação da escala de ansiedade pré-escolar, de s. Spence. Psicologia, Saúde & Doenças, 14(3), 470-483.

  BACKGROUND

• Webster-Stratton C, Reid MJ, Hammond M. Preventing conduct problems, promoting social competence: a parent and teacher training partnership in head start. J Clin Child Psychol. 2001 Sep;30(3):283-302. doi: 10.1207/S15374424JCCP3003_2.

  PMID: 11501247 BACKGROUND

• Sousa PM, Gaspar P, Fonseca H, Gaspar F. Association between treatment adherence and quality of life among overweight adolescents. Cad Saude Publica. 2017 Jan 23;33(1):e00171815. doi: 10.1590/0102-311X00171815.

  PMID: 28125128 BACKGROUND

• Luyten P, Mayes LC, Nijssens L, Fonagy P. The parental reflective functioning questionnaire: Development and preliminary validation. PLoS One. 2017 May 4;12(5):e0176218. doi: 10.1371/journal.pone.0176218. eCollection 2017.

  PMID: 28472162 BACKGROUND

• Moreira H, Fonseca A. Measuring Parental Reflective Functioning: Further Validation of the Parental Reflective Functioning Questionnaire in Portuguese Mothers of Infants and Young Children. Child Psychiatry Hum Dev. 2023 Aug;54(4):1042-1054. doi: 10.1007/s10578-021-01288-2. Epub 2022 Jan 22.

  PMID: 35064394 BACKGROUND

• [16] Achenbach, T. M., McConaughy, S. H., Ivanova, M. Y., & Rescorla, L. A. (2011). Manual for the ASEBA brief problem monitor (BPM). Burlington, VT: ASEBA, 33

  BACKGROUND

• [17] Stewart-Brown, S., & Janmohamed, K. (2008). Warwick-Edinburgh mental well-being scale. User guide. Version, 1(10.1037).

  BACKGROUND

• [18] Alho, L. J. N. D. S. (2021). Pandemia COVID-19: bem-estar e saúde mental de profissionais da saúde e da educação (Doctoral dissertation).

  BACKGROUND

MeSH Terms

Conditions

Mental Disorders

Interventions

Waiting Lists; Nocebo Effect

Intervention Hierarchy (Ancestors)

Appointments and Schedules; Organization and Administration; Health Services Administration; Placebo Effect; Effect Modifier, Epidemiologic; Epidemiologic Factors; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Bárbara Figueiredo

CONTACT

939993937; bbfi@psi.uminho.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor with Aggregation

Model Details: 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.

Study Record Dates

• First Submitted: July 28, 2022
• First Posted: August 8, 2022
• Study Start: February 4, 2021
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)