Clinical trial NCT06604585: The Parental Journey. Digital Tool for Security in Parenthood, a Way to Promote Public Health. A Pilot Study.
Official title: The Parental Journey. Digital Tool for Security in Parenthood, a Way to Promote Public Health. A Pilot Study.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Primary Prevention
Parenting
Family Relations
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
Collaborators: name: Göteborg University
First posted: 2024-09-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).
Primary purpose: PREVENTION

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. Is the digital parental support intervention feasible and helpful within primary care?
2. How do parents perceive the program "Parenting - a journey together"?
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?

Participants in this study will be parents of children aged 2-5 years who have expressed interest in participating in the study and in the parental support program. Participants will be randomized into either the intervention group or the control group. Participants will be asked to complete validated questionnaires measuring the parent-child relationship, perceived parental ability, stress, and well-being before and after the parental support program, and again after 3 months. These results will then be compared with those of the control group.The knowledge gained from the pilot study can contribute to the development of digital parental support interventions within primary care. If the pilot study proves that the interactive digital parenting program is feasible for use in child health centers and is perceived as helpful by parents, a larger randomized controlled (RCT) study, (not included in this application) will be conducted to evaluate its effectiveness.

Detailed description: Research question / Hypothesis / Theoretical framework:

Can a digital interactive parental support program be a tool to use within child health care to increase the feeling of security and competence in parenthood?

Additional research questions for the pilot study:

1. What is the percentage of those asked who agree to participate?
2. Can the execution of planned outcome measures be measured practically?
3. Is the intervention practically feasible with the resources that can be expected in a larger study?
4. How many parents terminate their participation in the study after they have been included?
5. How common is the occurrence of unexpected problems?
6. What change is observed between baseline and follow-up measurement of outcome measures in the two different groups?

Study Design:

Quantitative Experimental.

Intervention:

A pilot study will be conducted as a randomized clinical trial to evaluate and investigate whether the digital parent support intervention is feasible within primary care.

Selection Population:

Parents within child health services with children aged 2-5 years. Through a brief presentation of the parent support program and the pilot study in connection with visits to the child health center, where the parents also answer a few short questions, the nurse identifies parents who are interested in participating in the intervention: Parenting - a journey together, digital parent support program.

Method:

Group Division: A two-group design will be used where half are randomized to the intervention group with access to the parent support program and half to the control group with usual parental support without access to the digital parent support program. 1. Usual parental support. (n=15). 2. Usual parental support and digital parent support program. (n=15).

Data Collection:

Parents with children aged 2-5 years within child health services will be recruited to participate in the study. Four child health centers located in different parts of the Västra Götaland region are planned to participate in the recruitment of parents and the different child health centers will also test the intervention. After the parents have accepted participation in the study, all will answer the validated questionnaires that will be used to assess the primary outcome measures. Then a randomization to either intervention group or control group without access to the digital program for comparison is made. Measurement of the primary outcome measures in both groups will also take place after the intervention and 3 months after the intervention. The primary outcome measures include questions about the parent-child relationship, perceived parental capacity, stress and well-being. Surveys planned to be used are: "The Parental Reflective Functioning Questionnaire", "The Parenting Sense of Competence Scale", "The Swedish Parenthood Stress Questionnaire", "The Warwick-Edinburgh Mental Well-being Scale.

Data Processing:

Statistical analysis will be performed to compare the results for the intervention group with the control group. Appropriate statistical tests will be used to evaluate the effect of the digital parental support program on the primary outcome measures from the validated surveys. Descriptive statistics will also be used to present data. In the upcoming main study, the intention is to investigate changes over time in parental experience and the effect of the intervention on this. The same analysis will be performed in the pilot study, although the purpose then is not to demonstrate the effect of the intervention but only to obtain estimates that can facilitate the estimation of the sample size in the upcoming main study. The change in parental experience will be transformed into an ordinal scale with the scale steps improved (+1), unchanged (0), and worsened (-1). If there are few unchanged, the scale steps are transformed into improved (+1) or not improved (0). In the analysis, the transformed change becomes a dependent variable while the participants' gender, participants' age, group affiliation, and follow-up time become fixed independent variables. An interaction variable is also created between group affiliation and follow-up time and this is treated as a fixed effect. The expectation is that a child can have one, two, three, or four parents/partners who undergo the treatment. Randomization takes place per child, and analysis is based on the participants' responses. Each participant is assigned the child's code number. A virtual identification (ID) number will therefore be added for the child as a random effect variable.The statistical analysis becomes a mixed model ordered multivariable logistic regression or mixed model multivariable logistic regression depending on how the investigators choose to treat the dependent variable. The investigators have several outcome measures on parental experience and a separate regression is performed for each outcome measure.

Expected Outcome / Clinical Significance:

By giving parents the opportunity to reflect on their parenting, their interaction with the child, and also practice different ways of handling situations through the individual-based digital program, they are expected to become more confident in their parenting and feel more trust in themselves. This in turn leads to a more favorable environment for the child. The digital parenting support program means increased accessibility to parenting support with a small effort for primary care, and the format makes it possible to scale up to the entire Västra Götaland region. It could also be used nationally as it is on an online platform called "support and treatment". The digital parenting support program is expected to be part of the transformation of primary care for the future.

Project's Gender Perspective:

Traditional parenting support offered in various groups at child health centers and family centers usually attracts mostly mothers and the social profile tends to be more educated parents. This digital program is accessible to both parents and they can work with it when it suits them, which also increases the opportunity to reflect together. Thus, fathers are also involved in a better way than before.

Eligibility criteria: Inclusion Criteria:

* 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.
* Parents who respond affirmatively to the inclusion questions, indicating that they perceive a need for additional parental support and are motivated to participate in the program.

Inclusion questions for assessing a parent's needs and motivation to participate in the digital parenting support program:

1. How important do you consider your ability/confidence as a parent to be for you right now?
2. What has motivated you to consider participating in this program?
3. How motivated are you to make changes in your behavior to improve your parenting ability?
4. Do you have previous experiences with similar digital programs or parental support interventions? If yes, what was your experience?
5. What type of support do you think you need to successfully complete this program?

Exclusion Criteria:

* 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.

Primary outcomes:
measure: The Swedish Parenthood Stress Questionnaire - SPSQ
timeFrame: Measurement data is collected at baseline, pre intervention, immediately after the intervention, and 3 months after the intervention.
measure: The parental reflective functioning questionnaire- PRFQ
timeFrame: Measurement data is collected at baseline, pre intervention, immediately after the intervention, and 3 months after the intervention.
measure: The Parenting Sense of Competence scale -PSOC
timeFrame: Measurement data is collected at baseline, pre intervention, immediately after the intervention, and 3 months after the intervention.
measure: Short Warwick Edinburgh Mental Wellbeing Scale -SWEMWBS
timeFrame: Measurement data is collected at baseline, pre intervention, immediately after the intervention, and 3 months after the intervention.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Department of Psychology, Department of medicine, University of Gothenburg .
name: Sandra M Weineland, Ass prof
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.