- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06483841
Parents as Partners: Effectiveness of the Program in a Portuguese Sample
Parents as Partners: Effectiveness of the Program in a Portuguese Sample of Couples During the Transition to Parenthood
Study Overview
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Carolina Garraio, MsC
- Phone Number: 000-000-0000
- Email: carolinagarraio@fpce.up.pt
Study Locations
-
-
-
Porto, Portugal, 4200-135
- Recruiting
- Faculty of Psychology and Educational Sciences of the University of Porto
-
Contact:
- Carolina Garraio, Masters
- Phone Number: 000-000-0000
- Email: carolinagarraio@fpce.up.pt
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Severe mental health problems,
- Situations of domestic violence,
- Problematic use of alcohol and/or drugs.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Testing the Parents as Partners program
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.
|
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.
|
|
No Intervention: Wait-list control group
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Change from baseline (pre-test) to follow-up (6 months after the end of the program implementation).
|
|
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.
|
Change from baseline (pre-test) to follow-up (6 months after the end of the program implementation).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Parental Stress
Time Frame: Change from baseline (pre-test) to follow-up (6 months after the end of the program implementation).
|
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.
|
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).
|
Parenting Sense of Competence Scale: Scale ranges from 1 (strongly disagree) to 6 (strongly agree); Measures two dimensions: satisfaction and parenting effectiveness
|
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).
|
Work-Family Conflict Scale: Scale ranges from 1 (strongly disagree) to 5 (strongly agree)
|
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).
|
Work-Family Enrichment Scale: Scale ranges from 1 (strongly disagree) to 5 (strongly agree)
|
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).
|
Quality of Marriage Index: Scale ranges from 1 (very strongly disagree) to 7 (very strongly agree)
|
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).
|
Responsiveness Scale: Scale ranges from 1 (strongly disagree) to 7 (strongly agree)
|
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).
|
Brief Infant-Toddler Social and Emotional Assessment: Scale ranges from 1 (nothing like him/her) to 5 (exactly like him/her)
|
Change from baseline (pre-test) to follow-up (6 months after the end of the program implementation).
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perceived usefulness of the program
Time Frame: Post-test (immediately after the program)
|
Semi-structured interview with couples who participated in the IG
|
Post-test (immediately after the program)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Carolina Garraio, MsC, PhD candidate
Publications and helpful links
General Publications
- undefined
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2023/07-17
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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