Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06604585
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-11
Brief Title:
The Parental Journey Digital Tool for Security in Parenthood a Way to Promote Public Health A Pilot Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Parental Journey Digital Tool for Security in Parenthood a Way to Promote Public Health A Pilot Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 groupThe 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
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 groupThe 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 n15 2 Usual parental support and digital parent support program n15
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 parentspartners who undergo the treatment Randomization takes place per child and analysis is based on the participants responses Each participant is assigned the childs code number A virtual identification ID number will therefore be added for the child as a random effect variableThe 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
Projects 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
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 n15 2 Usual parental support and digital parent support program n15
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 parentspartners who undergo the treatment Randomization takes place per child and analysis is based on the participants responses Each participant is assigned the childs code number A virtual identification ID number will therefore be added for the child as a random effect variableThe 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
Projects 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None