Preliminary Efficacy of AdoptMindful2Care: A Pilot RCT With Adoptive Parents

Not Applicable

Not yet recruiting

• Conditions: Parenting Stress

• Registration Number: NCT07043660
• Lead Sponsor: University of Coimbra

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study Start: 2025-06-01
• Study First Submitted: 2025-06-20
• Study First Submitted QC: 2025-06-20
• Last Update Submitted: 2025-06-20
• Study First Posted: 2025-06-29
• Last Update Posted: 2025-06-29
• Primary Completion: 2026-07
• Study Completion: 2027-02-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 78

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes from baseline in parenting stress	Baseline, 2 and 4 months	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.

Secondary Outcome Measures

Name	Time	Method
Changes from baseline in mindful parenting	Baseline, 2 and 4 months	Measured with Interpersonal Mindfulness in Parenting Scale (IMP). The IMP is a 31-item self-report questionnaire; each item is rated on a 5-point Likert scale ranging from 1 (never true) to 5 (always true), with a higher total score indicating higher levels of mindful parenting.
Changes from baseline in anxiety and depressive symptoms	Baseline, 2 and 4 months	Measured with Hospital Anxiety and Depression Scale (HADS). HADS is a 14-item self-report questionnaire comprising 2 subscales: anxiety and depression. Each subscale consists of 7 items rated on a 4-point Likert scale. Subscale scores are calculated separately, with higher scores indicating higher levels of anxiety or depressive symptoms, respectively.
Changes from baseline in coparenting	Baseline, 2 and 4 months	Measured with Questionnaire on Parental Perceptions of Coparenting (QPPC). QPPC is a 14-item self-report questionnaire; each item is rated on a 5-point Likert scale ranging from 1 (never) to 5 (always), with a higher total score indicating greater perceived quality of coparenting.
Changes from baseline in children's emotional and behavioral difficulties	Baseline, 2 and 4 months	Measured with Strengths and Difficulties Questionnaire (SDQ). SDQ is a 25-items self-report questionnaire available in two versions (for ages 2-4 and 4-17), which share the same structure, scoring method, and interpretation. The SDQ comprises five subscales: Emotional Symptoms, Conduct Problems, Hyperactivity/Inattention, Peer Relationship Problems, and Prosocial Behavior. Items are rated on a 3-point Likert scale, from 0 (Not true) to 2 (Very true). The total difficulties score is calculated by summing the scores from all subscales except Prosocial Behavior, with higher scores indicating greater emotional and behavioral difficulties.
Changes from baseline in self-compassion	Baseline, 2 and 4 months	Measured with the Self-Compassion Scale - Short Form (SCS-SF). SCS-SF is a 12-item self-report questionnaire organized into six subscales: self-kindness, self-judgment, mindfulness, isolation, and overidentification. Items are rated on a 5-point Likert scale ranging from 1 (Almost never) to 5 (Almost always), with higher total scores indicating greater levels of self-compassion.
Changes from baseline in emotional regulation	Baseline, 2 and 4 months	Measured with the Difficulties in Emotion Regulation Scale - Short Form (DERS-SF). DERS-SF is an 18-item self-report questionnaire; each item is rated on a 5-point Likert scale ranging from 1 (Almost never) to 5 (Almost always), and a higher total score is indicative of more difficulties in emotion regulation.
Changes from baseline in mindfulness	Baseline, 2 and 4 months	Measured with the Mindful Attention and Awareness Scale (MAAS). MAAS is a 15-item self-report questionnaire; each item is rated on a 6-point Likert scale ranging from 1 (almost always) to 6 (almost never), with a higher total score indicating greater levels of mindfulness.
Acceptability of the intervention	2 months	Measured through specific questions (developed by the researchers) to assess acceptability.

Trial Locations

Locations (3)

Faculty of Psychology and Education Sciences, University of Coimbra; 🇵🇹 Coimbra, Portugal

Instituto da Segurança Social, I.P.; 🇵🇹 Lisboa, Portugal

Instituto da Segurança Social - Centro Distrital do Porto; 🇵🇹 Porto, Portugal