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| ID | Type | Description | Link |
|---|---|---|---|
| 2023.00703.BD | Other Grant/Funding Number | FundaĂ§Ă£o para a CiĂªncia e a Tecnologia | |
| CEECIND/02463/2017 | Other Grant/Funding Number | FundaĂ§Ă£o para a CiĂªncia e a Tecnologia | |
| FCG/Growing Minds 294688 | Other Grant/Funding Number | FundaĂ§Ă£o Calouste Gulbenkian |
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The development of post-adoption interventions aimed at promoting parental well-being and positive parenting is an urgent need. Mindful Parenting-based interventions appear to be particularly promising in this field, as they address parents' needs in coping with the emotional challenges of parenting and seem to foster greater compassionate, non-judgmental acceptance toward themselves and their children, as well as enhance the self-regulation of immediate emotional states in favor of long-term goals that support the parent-child relationship. However, the delivery of such interventions in face-to-face formats for adoptive parents (APs), particularly within the scope of universal prevention, faces considerable barriers (e.g., wide geographical dispersion of APs, limited mental health specialization among adoption service teams). eHealth tools represent an innovative pathway for intervention that may help overcome these barriers, given their multiple advantages, including: (1) improved access to healthcare regardless of time and location, (2) greater user autonomy in managing their own care, and (3) enhanced quality and innovation in service delivery, supported by the diversity, efficiency, and technological advancement of these systems. The primary goal of this study is to evaluate the effectiveness of AdoptMindful2Care@Web, a new 9-module, web-based post-adoption psychological intervention grounded in the principles of mindful parenting.
This pilot randomized controlled trial, with a two-arm design, precedes the full RCT planned as AdoptMindful2Care@Web. It is open to mothers and fathers who have at least one adoptive child under 18 years of age, whose adoption was legally decreed by the court less than 24 months prior to enrollment, who are not involved in any other ongoing adoption process, who are able to read and write in Portuguese, and who have regular access to the internet and electronic devices. A minimum of 90 families will be recruited with the support of all Portuguese governmental adoption agencies. After expressing interest in participating through an expression-of-interest form available on the project website, a member of the research team will contact them by telephone to conduct an initial screening (brief interview), with the following aims: (1) to clarify any questions regarding the study and (2) to assess their eligibility for participation (i.e., to confirm whether they meet the inclusion criteria and do not fall under any exclusion criteria). At the end of the telephone screening, they will be informed of the decision of eligibility. If deemed eligible and willing to participate, a specific date and time will be scheduled for completion of the online study assessment protocol corresponding to the first assessment point (T0). To support adherence to this appointment, a reminder will be sent on the scheduled day (via text message or email, as applicable).
Eligible participants will be randomly assigned to either the intervention group (AdoptMindful2Care@Web) or a waitlist control group (participants will receive the intervention after the study concludes). The intervention includes eight core modules plus a follow-up module, all carried out via an online platform, each lasting approximately 40 minutes. Participants in both groups will complete assessments at four time points: baseline, post-intervention, 1- and 2-month follow-up. These assessments will include both self-report (e.g., parenting stress) and hetero-report measures (e.g., children's emotional and developmental difficulties).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AdoptMindful2Care@Web Intervention | Experimental | Adoptive mothers and fathers will receive a structured 9-modules program based on mindful parenting principles, delivered through an online platform |
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| Waiting list group | Other | Adoptive mothers and fathers will not receive the intervention during the study period but will be offered and receive AdoptMindful2Care@Web after the final follow-up assessment is completed. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pAdoptMindful2Care@Web | Behavioral | AdoptMindful2Care@Web is a universal, preventive, web-based mindful parenting intervention for adoptive parents, adapted from its face-to-face version (AdoptMindful2Care). Delivered through an online platform, it includes eight self-guided core modules (approximately 40 minutes each) and one follow-up module. The core modules are sequential and unlocked upon completion of the previous one, with no fixed schedule. The follow-up module becomes available one month after completion of the final core module. Each module combines multimedia resources, including psychologist-recorded videos, animated videos, audio-guided exercises, and interactive/animated texts, to enhance engagement and accessibility. The intervention integrates psychoeducation, mindfulness-based exercises, mindful parenting and self-compassion practices, and strategies informed by Cognitive Behavioral Therapy (CBT), aiming to prevent or reduce parenting stress and promote positive parenting practices. |
| Measure | Description | Time Frame |
|---|---|---|
| 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, 3 and 4 months |
| Changes from baseline in Positive Mental Health | Measured with the Mental Health Continuum - Short Form. The 14 MHC-SF items are divided into three dimensions: emotional well-being, social well-being, and psychological well-being. Items are rated on a 6-point Likert scale ranging from 0 (never) to 5 (every day), with higher total scores indicating higher levels of positive mental health. | Baseline, 2, 3 and 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline in Mindful Parenting | 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. | Baseline, 2, 3 and 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ana Luz ChorĂ£o | Contact | +351 239 851 450 | ana-lc@live.com.pt |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Psychology and Education Sciences, University of Coimbra | Coimbra | 3000-115 | Portugal |
After the conclusion of the trial, the investigators plan to share the results of the study both with scientific community and health professionals.
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| Changes from baseline in Self-Compassion | 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. | Baseline, 2, 3 and 4 months |
| Changes from baseline in Anxiety and Depressive Symptoms | 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. | Baseline, 2, 3 and 4 months |
| Changes from baseline in Emotional Regulation | 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. | Baseline, 2, 3 and 4 months |
| Changes from baseline in Children's Socio-Emotional Functioning | 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. | Baseline, 2, 3 and 4 months |
| Acceptability of the intervention | Measured through specific questions (developed by the researchers) to assess acceptability. | 2 months |
| Socioeconomic value of the intervention | Measured through specific questions (developed by the researchers) to assess the socioeconomic value of the intervention. | Baseline, 2 months |