HealthyNCT06483841
Parents as Partners: Effectiveness of the Program in a Portuguese Sample
A study testing Parents as Partners in people with Healthy, run by Universidade do Porto at 1 site in Portugal.
Trial summary
This study aims to assess the effectiveness of the "Parents as Partners" program (also named "Supporting Father Involvement"; Cowan et al., 2009) in a sample of Portuguese couples going through the transition to parenthood, i.e., with one child up to the age of 3 years old. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Parents as Partners
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePortugal
- Study dates
- 20 Feb 2024to Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Heterosexual couples
- Both members of a couple accept to participate
- Couples should have only one child who should be up to 3 years of age
- Both members of the couple must have been parents for the first time together, i.e., they cannot have children from previous relationships
- Should live together.
Who cannot join
- Severe mental health problems,
- Situations of domestic violence,
- Problematic use of alcohol and/or drugs.
Trial locations and contacts
1 site in 1 country.
Portugal1 site, 1 recruiting
- Recruiting
Faculty of Psychology and Educational Sciences of the University of Porto
Porto, 4200-135
Carolina Garraio, Masters, 000-000-0000, carolinagarraio@fpce.up.pt
About this study
Official title: Parents as Partners: Effectiveness of the Program in a Portuguese Sample of Couples During the Transition to Parenthood
This study aims to assess the effectiveness of the "Parents as Partners" program (also named "Supporting Father Involvement"; Cowan et al., 2009) in a sample of Portuguese couples going through the transition to parenthood, i.e., with one child up to the age of 3 years old. The program aims to strengthen the coparenting relationship and consists of 2-hour 8 weekly group sessions attended by couples. Using a mixed-method approach, the researchers will conduct a randomized clinical trial aiming to assess the effectiveness of the intervention on primary and secondary outcomes. Lastly, participants' perceptions of the intervention usefulness will be assessed by conducting interviews with couples who participated in the intervention group (Parents as Partners).
Read the detailed description
This study was approved by the Ethics Committee of the Faculty of Psychology and Education Sciences of the University of Porto (Ref. 023/07-17).
The curriculum and assessment approach of \"Parents as Partners\" is built on a 5-domain risk and protective model: Parents as Individuals- Their health, mental health and general well-being; Parent-Child Relationships- Fathers' and mothers' age-appropriate parenting strategies; Couple Relationship- How parents manage their conflict and disagreement; coparenting that is more collaborative than undermining; Family of Origin Patterns- Parents' developmental histories with their parents; what is carried over from the past; how to interrupt intergenerational cycles of harsh treatment, abuse, and neglect; Stressors and Supports- Parents' strategies for coping with external stressors and enlisting support from family, friends, the workplace, and social services. The sessions will be led by two psychologists (male and female) who underwent 24-hour training by the Brazelton Touchpoints Center. The program has a 10-dimension fidelity assessment model, which will be complemented by session checklists. Furthermore, the facilitators will participate in weekly monitoring sessions with professionals specialized in the program.
Participants will be recruited from nurseries and private clinics.
After enrolling in the program, group facilitators conduct an initial interview to get to know the couple and clarify any questions they may have about the program. At this moment, couples will be asked to sign a consent form. After consenting to their participation, couples will be randomly assigned to one of two conditions: intervention group or waitlist-control group. The estimated sample size is 51 couples for the waitlist-control and intervention group each (power of .80; α = .05; G*Power 3.1.9.7). Participants will be assessed before and after the intervention on (co)parental, dyadic and work-family interface dimensions. Parents in the waitlist-control group will receive the intervention once their participation in the study is finished and if positive outcomes are found.
Hypotheses Group effects: The intervention group (IG) is expected to show an increase in coparenting relationship quality, parenting efficacy, and a decrease in parental stress compared to the wait-list control group (CG). Additionally, the investigators expect fathers in the IG to show an increase in parental involvement compared to those in the CG. As for secondary outcomes, the IG is expected to show an increase in the quality of the couple relationship, partner responsiveness and family-work enrichment, and a decrease in family-work conflict compared to the CG. Additionally, the researchers expect an improvement in child's social and emotional development.
Actor and partner effects: The improvement in parental indicators (e.g., parenting efficacy, parental stress) is expected to impact one's parental involvement and the partner's perception of partner responsiveness and coparenting relationship quality.
Statistical procedures: Intent to treat analysis will be applied. All data will be included regardless of participation rate. Repeated measures MANCOVA will be used to address within and between effects of the intervention, alongside T-Tests for comparing IG and CG, and controlling for mental health. The Actor-Partner Interdependence Model will be applied to assess actor and partner effects using Hierarchical Linear Modeling.
To assess the perceived usefulness of the intervention, 6-10 couples from the IG will be interviewed together using a semi-structured script after the posttest survey is completed. These interviews will be conducted by a researcher who has not been involved in the implementation of the program.
Participants data will be stored in an encrypted file, saved on a computer, and only accessible to the main researchers of this study. Confidentiality will be guaranteed by attributing an individual code to each participant/couple. Interviews will be recorded and transcribed and transcriptions will be marked with the same code to ensure the association of the collected data.
- Conditions
- Healthy
- Being tested
- Parents as Partners
- Keywords
- Randomized clinical trial, Transition to parenthood, Father involvement, Group intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parents as PartnersBehavioural
The Parents as Partners program consists of 8 weekly group sessions attended by couples and was developed to strengthen the coparental relationship and promote paternal involvement. After consenting to their participation, couples will be randomly assigned to one of two conditions: intervention group or waitlist-control group. Participants will be assessed before and after the intervention on (co)parental, dyadic and work-family dimensions. Baseline (before intervention), post-test (2 months after baseline) and a follow-up assessment 6 months after the program will be performed. The intervention group will participate in the program, focusing on 5 family domains: Parents as Individuals; Parent-Child Relationships; Couple Relationship; Family of Origin Patterns; Stressors and Supports. Parents in the waitlist-control group will receive the intervention once their participation in the study is finished and if positive outcomes are found.
| Study group | Role | What they receive |
|---|---|---|
| Testing the Parents as Partners program | Experimental | Couples (n=51) randomly assigned to this arm will go through 8 weekly group sessions of the Parents as Partners program, facilitated by two trained psychologists. Baseline, post-test and follow-up assessments will entail filling questionnaires collecting data on (co)parental, dyadic and work-family dimensions. At post-test, 6-10 couples will participate in an interview to collect information of their perceived usefulness of the intervention. Receives: Behavioral: Parents as Partners |
| Wait-list control group | No intervention | Couples (n=51) randomly assigned to this arm will not have access to the intervention during the 8 weeks period in which the intervention group is participating in the program. and until their participation in the study is finished, i.e., they have completed all assessments. Baseline, post-test and follow-up assessments will entail filling questionnaires collecting data on (co)parental, dyadic and work-family dimensions. After follow-up, this group will be offered to participate in the intervention if they wish to and if positive outcomes are found. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child-Parent Relationship
Child-Parent Relationship Scale - Short Form: Scale ranges from 1 (definitely does not apply) to 5 (definitively applies); Measures two dimensions: Conflict and Closeness
Measured: Change from baseline (pre-test) to follow-up (6 months after the end of the program implementation).
Coparenting Relationship
Coparenting Relationship Scale: Scale ranges from 0 (not true about us) to 6 (very much true about us); Measures seven dimensions: Coparenting agreement, closeness, exposure to conflict, coparenting support, undermining, endorsement of partner parenting and division of labor.
Measured: Change from baseline (pre-test) to follow-up (6 months after the end of the program implementation).
Secondary outcomes (7)
Parental Stress
Parental Stress Scale: Scale ranges from 1 (totally disagree) to 5 (totally agree); Measures four dimensions: Parental rewards, parental stressors, lack of control and parental satisfaction.
Measured: Change from baseline (pre-test) to follow-up (6 months after the end of the program implementation).
Parenting Efficacy
Parenting Sense of Competence Scale: Scale ranges from 1 (strongly disagree) to 6 (strongly agree); Measures two dimensions: satisfaction and parenting effectiveness
Measured: Change from baseline (pre-test) to follow-up (6 months after the end of the program implementation).
Family-Work Conflict
Work-Family Conflict Scale: Scale ranges from 1 (strongly disagree) to 5 (strongly agree)
Measured: Change from baseline (pre-test) to follow-up (6 months after the end of the program implementation).
Family-Work Enrichment
Work-Family Enrichment Scale: Scale ranges from 1 (strongly disagree) to 5 (strongly agree)
Measured: Change from baseline (pre-test) to follow-up (6 months after the end of the program implementation).
Quality of the Couple Relationship
Quality of Marriage Index: Scale ranges from 1 (very strongly disagree) to 7 (very strongly agree)
Measured: Change from baseline (pre-test) to follow-up (6 months after the end of the program implementation).
Partner Responsiveness
Responsiveness Scale: Scale ranges from 1 (strongly disagree) to 7 (strongly agree)
Measured: Change from baseline (pre-test) to follow-up (6 months after the end of the program implementation).
Child's Social and Emotional Development
Brief Infant-Toddler Social and Emotional Assessment: Scale ranges from 1 (nothing like him/her) to 5 (exactly like him/her)
Measured: Change from baseline (pre-test) to follow-up (6 months after the end of the program implementation).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start20 Feb 2024
- Primary completionMay 2025 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The Parents as Partners program consists of 8 weekly group sessions attended by couples and was developed to strengthen the coparental relationship and promote paternal involvement. After consenting to their participation, couples will be randomly assigned to one of two conditions: intervention group or waitlist-control group. Participants will be assessed before and after the intervention on (co)parental, dyadic and work-family dimensions. Baseline (before intervention), post-test (2 months after baseline) and a follow-up assessment 6 months after the program will be performed. The intervention group will participate in the program, focusing on 5 family domains: Parents as Individuals; Parent-Child Relationships; Couple Relationship; Family of Origin Patterns; Stressors and Supports. Parents in the waitlist-control group will receive the intervention once their parti
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade do Porto
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation for Science and Technology, Portugal
- Responsible party
- Sponsor
- Investigators
- Carolina Garraio, MsC, Principal investigator, PhD Candidate
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06483841
- Sponsor's protocol ID
- 2023/07-17
- Status last verified
- May 2024
- First submitted
- 17 Jun 2024
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
undefined
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parents as Partners: Effectiveness of the Program in a Portuguese Sample of Couples During the Transition to Parenthood
- ClinicalTrials.gov ID
- NCT06483841
- Acronym / sponsor ID
- 2023/07-17
- Conditions
- Healthy
- Keywords
- Randomized clinical trial, Transition to parenthood, Father involvement, Group intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- Collaborators
- Foundation for Science and Technology, Portugal
- Study start
- 20 Feb 2024 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 3 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to assess the effectiveness of the "Parents as Partners" program (also named "Supporting Father Involvement"; Cowan et al., 2009) in a sample of Portuguese couples going through the transition to parenthood, i.e., with one child up to the age of 3 years old. The program aims to strengthen the coparenting relationship and consists of 2-hour 8 weekly group sessions attended by couples. Using a mixed-method approach, the researchers will conduct a randomized clinical trial aiming to assess the effectiveness of the intervention on primary and secondary outcomes. Lastly, participants' perceptions of the intervention usefulness will be assessed by conducting interviews with couples who participated in the intervention group (Parents as Partners).
Detailed description
This study was approved by the Ethics Committee of the Faculty of Psychology and Education Sciences of the University of Porto (Ref. 023/07-17).
The curriculum and assessment approach of \"Parents as Partners\" is built on a 5-domain risk and protective model: Parents as Individuals- Their health, mental health and general well-being; Parent-Child Relationships- Fathers' and mothers' age-appropriate parenting strategies; Couple Relationship- How parents manage their conflict and disagreement; coparenting that is more collaborative than undermining; Family of Origin Patterns- Parents' developmental histories with their parents; what is carried over from the past; how to interrupt intergenerational cycles of harsh treatment, abuse, and neglect; Stressors and Supports- Parents' strategies for coping with external stressors and enlisting support from family, friends, the workplace, and social services. The sessions will be led by two psychologists (male and female) who underwent 24-hour training by the Brazelton Touchpoints Center. The program has a 10-dimension fidelity assessment model, which will be complemented by session checklists. Furthermore, the facilitators will participate in weekly monitoring sessions with professionals specialized in the program.
Participants will be recruited from nurseries and private clinics.
After enrolling in the program, group facilitators conduct an initial interview to get to know the couple and clarify any questions they may have about the program. At this moment, couples will be asked to sign a consent form. After consenting to their participation, couples will be randomly assigned to one of two conditions: intervention group or waitlist-control group. The estimated sample size is 51 couples for the waitlist-control and intervention group each (power of .80; α = .05; G*Power 3.1.9.7). Participants will be assessed before and after the intervention on (co)parental, dyadic and work-family interface dimensions. Parents in the waitlist-control group will receive the intervention once their participation in the study is finished and if positive outcomes are found.
Hypotheses Group effects: The intervention group (IG) is expected to show an increase in coparenting relationship quality, parenting efficacy, and a decrease in parental stress compared to the wait-list control group (CG). Additionally, the investigators expect fathers in the IG to show an increase in parental involvement compared to those in the CG. As for secondary outcomes, the IG is expected to show an increase in the quality of the couple relationship, partner responsiveness and family-work enrichment, and a decrease in family-work conflict compared to the CG. Additionally, the researchers expect an improvement in child's social and emotional development.
Actor and partner effects: The improvement in parental indicators (e.g., parenting efficacy, parental stress) is expected to impact one's parental involvement and the partner's perception of partner responsiveness and coparenting relationship quality.
Statistical procedures: Intent to treat analysis will be applied. All data will be included regardless of participation rate. Repeated measures MANCOVA will be used to address within and between effects of the intervention, alongside T-Tests for comparing IG and CG, and controlling for mental health. The Actor-Partner Interdependence Model will be applied to assess actor and partner effects using Hierarchical Linear Modeling.
To assess the perceived usefulness of the intervention, 6-10 couples from the IG will be interviewed together using a semi-structured script after the posttest survey is completed. These interviews will be conducted by a researcher who has not been involved in the implementation of the program.
Participants data will be stored in an encrypted file, saved on a computer, and only accessible to the main researchers of this study. Confidentiality will be guaranteed by attributing an individual code to each participant/couple. Interviews will be recorded and transcribed and transcriptions will be marked with the same code to ensure the association of the collected data.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The Parents as Partners program consists of 8 weekly group sessions attended by couples and was developed to strengthen the coparental relationship and promote paternal involvement. After consenting to their participation, couples will be randomly assigned to one of two conditions: intervention group or waitlist-control group. Participants will be assessed before and after the intervention on (co)parental, dyadic and work-family dimensions. Baseline (before intervention), post-test (2 months after baseline) and a follow-up assessment 6 months after the program will be performed. The intervention group will participate in the program, focusing on 5 family domains: Parents as Individuals; Parent-Child Relationships; Couple Relationship; Family of Origin Patterns; Stressors and Supports. Parents in the waitlist-control group will receive the intervention once their parti
| Arm | Type | Receives |
|---|---|---|
| Testing the Parents as Partners program | Experimental | Behavioral: Parents as PartnersCouples (n=51) randomly assigned to this arm will go through 8 weekly group sessions of the Parents as Partners program, facilitated by two trained psychologists. Baseline, post-test and follow-up assessments will entail filling questionnaires collecting data on (co)parental, dyadic and work-family dimensions. At post-test, 6-10 couples will participate in an interview to collect information of their perceived usefulness of the intervention. |
| Wait-list control group | No intervention | –Couples (n=51) randomly assigned to this arm will not have access to the intervention during the 8 weeks period in which the intervention group is participating in the program. and until their participation in the study is finished, i.e., they have completed all assessments. Baseline, post-test and follow-up assessments will entail filling questionnaires collecting data on (co)parental, dyadic and work-family dimensions. After follow-up, this group will be offered to participate in the intervention if they wish to and if positive outcomes are found. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Heterosexual couples
- Both members of a couple accept to participate
- Couples should have only one child who should be up to 3 years of age
- Both members of the couple must have been parents for the first time together, i.e., they cannot have children from previous relationships
- Should live together.
Key exclusion criteria (3 listed)
- Severe mental health problems,
- Situations of domestic violence,
- Problematic use of alcohol and/or drugs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parents as PartnersThe Parents as Partners program consists of 8 weekly group sessions attended by couples and was developed to strengthen the coparental relationship and promote paternal involvement. After consenting to their participation, couples will be randomly assigned to one of two conditions: intervention group or waitlist-control group. Participants will be assessed before and after the intervention on (co)parental, dyadic and work-family dimensions. Baseline (before intervention), post-test (2 months after baseline) and a follow-up assessment 6 months after the program will be performed. The intervention group will participate in the program, focusing on 5 family domains: Parents as Individuals; Parent-Child Relationships; Couple Relationship; Family of Origin Patterns; Stressors and Supports. Parents in the waitlist-control group will receive the intervention once their participation in the study is finished and if positive outcomes are found. | Behavioural | Testing the Parents as Partners program |
Primary outcome
Child-Parent Relationship
Time frame: Change from baseline (pre-test) to follow-up (6 months after the end of the program implementation).
Child-Parent Relationship Scale - Short Form: Scale ranges from 1 (definitely does not apply) to 5 (definitively applies); Measures two dimensions: Conflict and Closeness
Coparenting Relationship
Time frame: Change from baseline (pre-test) to follow-up (6 months after the end of the program implementation).
Coparenting Relationship Scale: Scale ranges from 0 (not true about us) to 6 (very much true about us); Measures seven dimensions: Coparenting agreement, closeness, exposure to conflict, coparenting support, undermining, endorsement of partner parenting and division of labor.
7 secondary outcomes
Parental Stress
Time frame: Change from baseline (pre-test) to follow-up (6 months after the end of the program implementation).
Parenting Efficacy
Time frame: Change from baseline (pre-test) to follow-up (6 months after the end of the program implementation).
Family-Work Conflict
Time frame: Change from baseline (pre-test) to follow-up (6 months after the end of the program implementation).
Family-Work Enrichment
Time frame: Change from baseline (pre-test) to follow-up (6 months after the end of the program implementation).
Quality of the Couple Relationship
Time frame: Change from baseline (pre-test) to follow-up (6 months after the end of the program implementation).
Partner Responsiveness
Time frame: Change from baseline (pre-test) to follow-up (6 months after the end of the program implementation).
Child's Social and Emotional Development
Time frame: Change from baseline (pre-test) to follow-up (6 months after the end of the program implementation).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Backgroundundefined
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carolina Garraio, MsC principal investigator
PhD Candidate
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parents as Partners in people with Healthy, run by Universidade do Porto at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carolina Garraio, MsC (000-000-0000, carolinagarraio@fpce.up.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child-Parent Relationship (time frame: Change from baseline (pre-test) to follow-up (6 months after the end of the program implementation).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06483841, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024; AzTrials last refreshed its copy on 7 Nov 2026.