Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2025-12-26 @ 12:42 AM
Study NCT ID:
NCT07043660
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-29
First Post:
2025-06-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Preliminary Efficacy of AdoptMindful2Care: A Pilot RCT With Adoptive Parents
Sponsor:
University of Coimbra
Organization:
Study Overview
Official Title:
Promoting Adoptive Parents' Well-being: A Randomized Controlled Pilot Trial to Evaluate a Mindful Parenting Post-adoption Intervention
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Adoptive parents often face additional challenges related to the adoption process, which can increase their vulnerability to parenting stress and negatively affect their parenting practices and overall family well-being. These risks highlight the urgent need to implement post-adoption interventions that reduce parenting stress and promote both parental well-being and positive parenting practices.
In this study, we aim to evaluate the preliminary efficacy of AdoptMindful2Care, a new 8-week, face-to-face, group-based psychological intervention grounded in the principles of mindful parenting. This pilot randomized controlled trial, which uses a two-arm design, serves as a preliminary step before conducting the full-scale RCT planned for AdoptMindful2Care.
We will invite both mothers and fathers to participate if they have at least one adoptive child between the ages of 2 and 17 and if the legal adoption decree was finalized in court at least 12 months before enrollment. We will target parents who report moderate to high levels of parenting stress. With the support of all Portuguese governmental adoption agencies, we plan to recruit a minimum of 78 families.
After parents express interest in participating, we will screen them to assess their levels of parenting stress. For those who meet the initial criteria, we will conduct a structured clinical interview (SCID-5-CV) to rule out severe mental illness. If they meet all inclusion criteria and present no exclusion criteria, we will proceed with a final interview to guide them through the informed consent process.
We will randomly assign eligible participants to either the intervention group (AdoptMindful2Care) or a waitlist control group (who will receive the intervention after the study concludes). All participants will be informed that they will be randomized to one of the study groups and that they will only be included if they give informed consent to participate in the study. We will deliver the intervention in person, in a group format, through eight weekly sessions and one follow-up session, each lasting approximately 90 minutes.
All participants will complete assessments at three time points: baseline, post-intervention, and 2-month follow-up. These assessments will include self-report measures (e.g., parenting stress) and hetero-report measures (e.g., children's emotional and developmental difficulties).
In this study, we aim to evaluate the preliminary efficacy of AdoptMindful2Care, a new 8-week, face-to-face, group-based psychological intervention grounded in the principles of mindful parenting. This pilot randomized controlled trial, which uses a two-arm design, serves as a preliminary step before conducting the full-scale RCT planned for AdoptMindful2Care.
We will invite both mothers and fathers to participate if they have at least one adoptive child between the ages of 2 and 17 and if the legal adoption decree was finalized in court at least 12 months before enrollment. We will target parents who report moderate to high levels of parenting stress. With the support of all Portuguese governmental adoption agencies, we plan to recruit a minimum of 78 families.
After parents express interest in participating, we will screen them to assess their levels of parenting stress. For those who meet the initial criteria, we will conduct a structured clinical interview (SCID-5-CV) to rule out severe mental illness. If they meet all inclusion criteria and present no exclusion criteria, we will proceed with a final interview to guide them through the informed consent process.
We will randomly assign eligible participants to either the intervention group (AdoptMindful2Care) or a waitlist control group (who will receive the intervention after the study concludes). All participants will be informed that they will be randomized to one of the study groups and that they will only be included if they give informed consent to participate in the study. We will deliver the intervention in person, in a group format, through eight weekly sessions and one follow-up session, each lasting approximately 90 minutes.
All participants will complete assessments at three time points: baseline, post-intervention, and 2-month follow-up. These assessments will include self-report measures (e.g., parenting stress) and hetero-report measures (e.g., children's emotional and developmental difficulties).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: