- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07534111
Preliminary Efficacy of the AdoptMindful2Care@Web: A Web-Based Mindful Parenting Post-Adoption Intervention for Adoptive Parents
Adopting eMental Health IV: A Randomized Controlled Pilot Trial to Evaluate a Web-Based Mindful Parenting Post-Adoption Intervention
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).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ana Luz Chorão
- Phone Number: +351 239 851 450
- Email: ana-lc@live.com.pt
Study Locations
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-
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Coimbra, Portugal, 3000-115
- Faculty of Psychology and Education Sciences, University of Coimbra
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Contact:
- Ana Luz Chorão
- Phone Number: +351 239 851 450
- Email: ana-lc@live.com.pt
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Have at least one adoptive child aged under 18 years
- Have an adoption decreed by the court less than 24 months ago
- Have no other adoption process in progress
- Have reading and writing abilities in the Portuguese language
- Have regular access to the internet and electronic devices
Exclusion Criteria:
- Presence of a severe mental disorder (e.g., schizophrenia, substance abuse, bipolar disorder).
- Have previously participated in the face-to-face, group-based version of the programme (pAdoptMindful2Care)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: AdoptMindful2Care@Web Intervention
Adoptive mothers and fathers will receive a structured 9-modules program based on mindful parenting principles, delivered through an online platform
|
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.
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|
Other: Waiting list group
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes from baseline in Parenting Stress
Time Frame: Baseline, 2, 3 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.
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Baseline, 2, 3 and 4 months
|
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Changes from baseline in Positive Mental Health
Time Frame: Baseline, 2, 3 and 4 months
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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.
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Baseline, 2, 3 and 4 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Acceptability of the intervention
Time Frame: 2 months
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Measured through specific questions (developed by the researchers) to assess acceptability.
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2 months
|
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Changes from baseline in Mindful Parenting
Time Frame: Baseline, 2, 3 and 4 months
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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.
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Baseline, 2, 3 and 4 months
|
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Changes from baseline in Self-Compassion
Time Frame: Baseline, 2, 3 and 4 months
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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.
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Baseline, 2, 3 and 4 months
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Changes from baseline in Anxiety and Depressive Symptoms
Time Frame: Baseline, 2, 3 and 4 months
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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
|
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Changes from baseline in Emotional Regulation
Time Frame: Baseline, 2, 3 and 4 months
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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.
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Baseline, 2, 3 and 4 months
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Changes from baseline in Children's Socio-Emotional Functioning
Time Frame: Baseline, 2, 3 and 4 months
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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.
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Baseline, 2, 3 and 4 months
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Socioeconomic value of the intervention
Time Frame: Baseline, 2 months
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Measured through specific questions (developed by the researchers) to assess the socioeconomic value of the intervention.
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Baseline, 2 months
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- pAM2C@WEB/2023.00703
- CEECIND/02463/2017 (Other Grant/Funding Number: Fundação para a Ciência e a Tecnologia)
- 2023.00703.BD (Other Grant/Funding Number: Fundação para a Ciência e a Tecnologia)
- FCG/Growing Minds 294688 (Other Grant/Funding Number: Fundação Calouste Gulbenkian)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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