The Parental Journey. Digital Tool for Security in Parenthood, a Way to Promote Public Health. A Pilot Study.

NCT06604585 | Not Yet Recruiting

• 1 other identifier: 277873
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this randomized clinical pilot study is to evaluate the feasibility and experience of the internet-based parental support program "Parenting - a journey together". This program is intended to be delivered via the national Support and Treatment Platform and used within primary care to enhance traditional parental support within child health care when needed. The main questions it aims to answer are:

1. 1.Is the digital parental support intervention feasible and helpful within primary care?
2. 2.How do parents perceive the program "Parenting - a journey together"?
3. 3.Does the program increase the sense of parental ability and security in parenting by reflecting on attitudes and approaches in interaction with the child?

Conditions

Primary Prevention; Parenting; Family Relations

Outcome Measures

Primary Outcomes (4)

• The Swedish Parenthood Stress Questionnaire - SPSQ

  The Swedish Parenthood Stress Questionnaire (SPSQ) is designed to measure the perceived stress/strain that parents can directly relate to their parenthood. The questionnaire is influenced by, and primarily originates from parts of R. Abidin's Parenting Stress Index (PSI; Abidin, 1990). In early publications (Östberg, Hagekull, \& Wettergren, 1997), SPSQ was referred to as a Swedish PSI (S-PSI) to facilitate comparisons with the American scale. In accordance with an agreement with the American publisher that holds the copyright to the PSI scale, the name has been changed to The Swedish Parenthood Stress Questionnaire (SPSQ). SPSQ is based on 35 selected questions from PSI, with clear and high/acceptable factor loadings (Abidin, 1990). The questions have been selected from the subscales Depression, Restrictions of Role, Sense of Competence, Social Isolation, Relationship with Spouse and Parent Health.

  Measurement data is collected at baseline, pre intervention, immediately after the intervention, and 3 months after the intervention.

• The parental reflective functioning questionnaire- PRFQ

  The Parental Reflective Functioning Questionnaire (PRFQ) has been developed to provide a brief, multidimensional assessment of parental reflective functioning that is easy to administer to parents with a wide range of socioeconomic and educational backgrounds. Because of the current interest in the role of PRF in the intergenerational transmission of attachment in early childhood, the PRFQ was primarily designed for parents of children 0-5 years of age. The questionnaire consists of 18 items.

  Measurement data is collected at baseline, pre intervention, immediately after the intervention, and 3 months after the intervention.

• The Parenting Sense of Competence scale -PSOC

  The Parenting Sense of Competence scale (PSOC) is a self-report measure that aims to assesses one's perceived efficacy and satisfaction with parenting. One of the most used scales to measure this construct is Johnston and Mash's version of the Parenting Sense of Competence (PSOC) questionnaire. This scale consists of 16 items and evaluates the caregiver's perceived parenting competence through its two dimensions: efficacy, i.e., the degree to which the parent feels competent in their parenting role and satisfaction, i.e., the extent to which the caregiver feels satisfied with their role as a parent.

  Measurement data is collected at baseline, pre intervention, immediately after the intervention, and 3 months after the intervention.

• Short Warwick Edinburgh Mental Wellbeing Scale -SWEMWBS

  The Short Warwick Edinburgh Mental Wellbeing scale (SWEMWBS) is a short version of the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS). The WEMWBS was developed to enable the monitoring of mental wellbeing in the general population and the evaluation of projects, programmes and policies which aim to improve mental wellbeing. The SWEMWBS uses seven of the WEMWBS's 14 statements about thoughts and feelings, which relate more to functioning than feelings and so offer a slightly different perspective on mental wellbeing.

  Measurement data is collected at baseline, pre intervention, immediately after the intervention, and 3 months after the intervention.

Study Arms (2)

The intervention- an interactive digital parental support program in primary care.

EXPERIMENTAL

The intervention group will receive conventional parental support according to the national child health care programme. Additionally, they will have access to the digital parental support program, 'Parenthood - A Journey Together'."

Behavioral: Parenthood - a journey together. Digital tool to increase security in parenthood, a way to promote public health..

The control group without access to the digital parental support program.

NO INTERVENTION

The control group will receive conventional parental support according to the national child health care programme, without access to the digital parental support program, 'Parenthood - A Journey Together'."

Interventions

Parenthood - a journey together. Digital tool to increase security in parenthood, a way to promote public health.. BEHAVIORAL

The project involved the development of an internet-based parental support program to be delivered via the national Support and Treatment (Sob) platform and used in primary care to enhance traditional parental support within child healthcare, as needed. The innovation has been developed in collaboration with the Innovation Fund in Västra Götaland. The aim is to increase the experience of parental competence and a sense of security in parenting by reflecting on attitudes and approaches in interaction with the child through an interactive, digital parental support program. The four themes in the parental support program, "Parenthood a journey together", are named: Being a good enough parent, understanding one's child, interacting with one's child, and meeting daily challenges as a parent regarding food, sleep, play, screen time, and physical activity. The four modules will include explanatory and psychoeducational texts, written exercises, videos, and homework.

The intervention- an interactive digital parental support program in primary care.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult parents (or another adult who is a primary caregiver) to children within pediatric healthcare services with children aged 2-5 years old.
• The parents are not participating in other parental support programs or interventions from Child Health Care psychologists, as this would complicate the evaluation of the effects of each intervention.
• Parents who speak Swedish, due to the fact that "Parenting - a journey together" has not yet been translated into other languages.
• How important do you consider your ability/confidence as a parent to be for you right now?
• What has motivated you to consider participating in this program?
• How motivated are you to make changes in your behavior to improve your parenting ability?
• Do you have previous experiences with similar digital programs or parental support interventions? If yes, what was your experience?
• What type of support do you think you need to successfully complete this program?

You may not qualify if:

• Parents of children outside the 2-5 years age range. The program is specifically designed for parents within child health care with children in this age group. Once children reach the age of 6, they transition to school health care.
• The parents who are already participating in other parental support programs or receiving interventions from Child Health Care psychologists are not eligible, as this would complicate the evaluation of the effects of each intervention.
• Parents who do not speak Swedish, as the program 'Parenting - a Journey Together' has not yet been translated into other languages.
• Parents who have indicated no perceived need for additional parental support.

Sponsors & Collaborators

• Vastra Gotaland Region: lead
• Göteborg University: collaborator

Related Publications (4)

• 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

• Ostberg M, Hagekull B, Wettergren S. A measure of parental stress in mothers with small children: dimensionality, stability and validity. Scand J Psychol. 1997 Sep;38(3):199-208. doi: 10.1111/1467-9450.00028.

  PMID: 9309950 BACKGROUND

• Gilmore L, Cuskelly M. Factor structure of the Parenting Sense of Competence scale using a normative sample. Child Care Health Dev. 2009 Jan;35(1):48-55. doi: 10.1111/j.1365-2214.2008.00867.x. Epub 2008 Oct 22.

  PMID: 18991983 BACKGROUND

• Tennant R, Hiller L, Fishwick R, Platt S, Joseph S, Weich S, Parkinson J, Secker J, Stewart-Brown S. The Warwick-Edinburgh Mental Well-being Scale (WEMWBS): development and UK validation. Health Qual Life Outcomes. 2007 Nov 27;5:63. doi: 10.1186/1477-7525-5-63.

  PMID: 18042300 BACKGROUND

Study Officials

• Sandra M Weineland, Ass prof

  Department of Psychology, Department of medicine, University of Gothenburg .

  STUDY DIRECTOR

Central Study Contacts

Helena M Lorén, PHD student

CONTACT

+46730227042; helena.loren@vgregion.se

Sandra M Weineland, Ass Prof

CONTACT

+46708735788; sandra.weineland@psy.gu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: The pilot study will be conducted as a randomized clinical trial. We will use a two-group design where half of the participants are randomized to the intervention group with access to the digital parent support program and half to the control group with conventional parental support without access to the digital parental support program, 1. Conventional parental support and digital parent support program. (n=15). 2. Conventional parental support (n=15).

Study Record Dates

• First Submitted: September 11, 2024
• First Posted: September 19, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 1. Individual participant data (IPD): Available within 6 months after primary results publication or study completion. 2. Study Protocol: Available upon request after trial results are published. 3. Statistical Analysis Plan: Shared upon request post-primary manuscript publication. 4. Informed Consent Form (ICF): De-identified ICF available upon request post-trial. 5. Clinical Study Report: Available upon request post-results publication. 6. Analytic Code:Shared upon request post-primary results publication for transparency. Conditions for Access: Formal request and data sharing agreement required. Agreement covers data use, privacy compliance, and ethical standards. Researchers must submit a research plan and ethics approval. PI reviews all requests for compliance.
• Access Criteria: 1. Research Proposal: Submit a proposal detailing objectives, methodology, impact, and specific IPD usage. 2. Ethics Approval: Provide evidence of ethics committee approval confirming ethical soundness. 3. Data Use Agreement (DUA): Sign a DUA outlining data access terms, including security, confidentiality, and usage limitations. 4. Data Security Measures: Demonstrate secure IPD handling, including encryption and access controls. 5. Researcher Qualifications: Provide academic and professional background to ensure research expertise. 6. Transparency and Accountability: Share results with the data provider before publication and acknowledge the data source. 7. Purpose Limitation: Use data solely for the specified research purpose. 8. Publication and Data Sharing: Commit to publishing findings in peer-reviewed journals and sharing results with the scientific community. 9. Compliance with Regulations: Comply with all applicable data protection laws, including GDPR.