NCT07043660

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, the research team aims 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. The investigators 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. The investigators will target parents who report moderate to high levels of parenting stress. With the support of all Portuguese governmental adoption agencies, the researchers plan to recruit a minimum of 78 families. After parents express interest in participating, the investigators will screen them to assess their levels of parenting stress. For those who meet the initial criteria, the investigators will conduct a structured clinical interview (SCID-5-CV) to rule out severe mental illness. If participants meet all inclusion criteria and present no exclusion criteria, the investigators will proceed with a final interview to guide them through the informed consent process. The investigators 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. The investigators 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).

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
9mo left

Started Jun 2025

Geographic Reach
1 country

4 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress54%
Jun 2025Feb 2027

First Submitted

Initial submission to the registry

June 20, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 29, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

June 30, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

February 9, 2026

Status Verified

February 1, 2026

Enrollment Period

1 year

First QC Date

June 20, 2025

Last Update Submit

February 4, 2026

Conditions

Keywords

parenting stressmindful parenting interventionadoptive parentspostadoption

Outcome Measures

Primary Outcomes (1)

  • Changes from baseline in parenting stress

    Measured with Parenting Stress Index - Short Form. The 36 PSI-SF items are divided into three subscales: parenting difficulties, dysfunctional parent-child interactions, and child difficulties. Items are rated on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree), with higher total scores indicating higher levels of parenting stress.

    Baseline, 2 and 4 months

Secondary Outcomes (8)

  • Changes from baseline in mindful parenting

    Baseline, 2 and 4 months

  • Changes from baseline in anxiety and depressive symptoms

    Baseline, 2 and 4 months

  • Changes from baseline in coparenting

    Baseline, 2 and 4 months

  • Changes from baseline in children's emotional and behavioral difficulties

    Baseline, 2 and 4 months

  • Changes from baseline in self-compassion

    Baseline, 2 and 4 months

  • +3 more secondary outcomes

Study Arms (2)

AdoptMindful2Care Intervention

EXPERIMENTAL

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

Behavioral: AdoptMindful2Care

Waiting list group

OTHER

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.

Behavioral: AdoptMindful2Care

Interventions

AdoptMindful2Care is a mindful parenting post-adoption intervention with eight weekly group sessions (approximately 90 minutes each), delivered in person by trained psychologists, plus one follow-up session held two months after completion. The intervention integrates psychoeducation, mindfulness-based exercises, mindful parenting and self-compassion practices, as well as strategies informed by Cognitive Behavioral Therapy (CBT). The program is designed to help adoptive parents reduce parenting stress and promote positive parenting practices.

AdoptMindful2Care InterventionWaiting list group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Instituto da Segurança Social - Centro Distrital de Aveiro

Aveiro, 3804-504, Portugal

Location

Faculty of Psychology and Education Sciences, University of Coimbra

Coimbra, 3000-115, Portugal

Location

Instituto da Segurança Social, I.P.

Lisbon, 1050-063, Portugal

Location

Instituto da Segurança Social - Centro Distrital do Porto

Porto, 4199-001, Portugal

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 20, 2025

First Posted

June 29, 2025

Study Start

June 30, 2025

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

February 1, 2027

Last Updated

February 9, 2026

Record last verified: 2026-02

Locations