Preliminary Efficacy of AdoptMindful2Care: A Pilot RCT With Adoptive Parents

University of Coimbra

Status: Not yet enrolling

Conditions: Parenting Stress

Treatments: Behavioral: AdoptMindful2Care

Study type: Interventional

Funder types: Other

Identifiers

NCT07043660

pAdoptMindful2Care/154436/2022

UI/BD/154436/2022 (Other Grant/Funding Number)

CEECIND/02463/2017 (Other Grant/Funding Number)

Details and patient eligibility

About

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).

Enrollment: 78 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Being a mother and/or father of at least one adoptive child aged between 2 and 17 years old, inclusive.
• The adoption must have been legally finalized in court for more than 12 months.
• Presence of moderate to high levels of parenting stress.

Exclusion criteria

• Presence of a severe mental disorder (e.g., schizophrenia, substance abuse, bipolar disorder).
• Are receiving another psychological intervention focused on parenting issues.
• Are receiving technical support under a child and youth protection measure that involves the institutionalization of the child/youth.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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78 participants in 2 patient groups

AdoptMindful2Care Intervention

Experimental group

Description:

Adoptive mothers and fathers will receive a structured 8-week group program based on mindful parenting principles, delivered in person during the study period

Treatment:

Behavioral: AdoptMindful2Care

Waiting list group

Other group

Description:

Adoptive mothers and fathers will not receive the intervention during the study period but will be offered and receive AdoptMindful2Care after the final follow-up assessment is completed.

Treatment:

Behavioral: AdoptMindful2Care