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NCT Number: NCT07043660

Preliminary Efficacy of AdoptMindful2Care: A Mindful Parenting Post-adoption Intervention for Adoptive Parents

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).

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Key information

Conditions

Parenting Stress

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto da Segurança Social - Centro Distrital de Aveiro, Aveiro, Portugal

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AdoptMindful2Care

Behavioral

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.

Primary outcomes

  1. Changes from baseline in parenting stress

    Time frame: 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 outcomes

  1. Changes from baseline in mindful parenting

    Time frame: 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.

  2. Changes from baseline in anxiety and depressive symptoms

    Time frame: 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.

  3. Changes from baseline in coparenting

    Time frame: 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.

  4. Changes from baseline in children's emotional and behavioral difficulties

    Time frame: 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.

  5. Changes from baseline in self-compassion

    Time frame: 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.

  6. Changes from baseline in emotional regulation

    Time frame: 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.

  7. Changes from baseline in mindfulness

    Time frame: 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.

  8. Acceptability of the intervention

    Time frame: 2 months

    Measured through specific questions (developed by the researchers) to assess acceptability.

Sponsors and collaborators

Lead sponsor

University of Coimbra

Other

Collaborators

  • Fundação para a Ciência e a Tecnologia

Registry information

Official study title

Promoting Adoptive Parents' Well-being: A Randomized Controlled Pilot Trial to Evaluate a Mindful Parenting Post-adoption Intervention

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jun 29, 2025
Registry last updated
Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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