Parenting StressNCT07534111
Preliminary Efficacy of the AdoptMindful2Care@Web: A Web-Based Mindful Parenting Post-Adoption Intervention for Adoptive Parents
A study testing pAdoptMindful2Care@Web in people with Parenting Stress and Positive Mental Health, run by University of Coimbra at 1 site in Portugal.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Parenting Stress, Positive Mental Health
- What is being tested?
- pAdoptMindful2Care@Web
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 sitePortugal
- Study dates
- 20 Apr 2026to Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Portugal1 site, 1 recruiting
- Recruiting
Faculty of Psychology and Education Sciences, University of Coimbra
Coimbra, 3000-115
Ana Luz Chorão, +351 239 851 450, ana-lc@live.com.pt
About this study
Official title: 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).
- Conditions
- Parenting Stress, Positive Mental Health
- Being tested
- pAdoptMindful2Care@Web
- Keywords
- Parenting Stress, Positive Mental Health, Mindful Parenting Intervention, Adoptive Parents, Post-Adoption, Web-Based
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pAdoptMindful2Care@WebBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: pAdoptMindful2Care@Web |
| 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. Receives: Behavioral: pAdoptMindful2Care@Web |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, 2, 3 and 4 months
Secondary outcomes (7)
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.
Measured: Baseline, 2, 3 and 4 months
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 2, 3 and 4 months
Acceptability of the intervention
Measured through specific questions (developed by the researchers) to assess acceptability.
Measured: 2 months
Socioeconomic value of the intervention
Measured through specific questions (developed by the researchers) to assess the socioeconomic value of the intervention.
Measured: Baseline, 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start20 Apr 2026
- Primary completionApr 2027 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parenting StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Coimbra
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana Luz Chorão, University of Coimbra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07534111
- Sponsor's protocol ID
- pAM2C@WEB/2023.00703
- Other IDs
- 2023.00703.BD, CEECIND/02463/2017, FCG/Growing Minds 294688, 2023
- Status last verified
- Oct 2026
- First submitted
- 9 Apr 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: After the conclusion of the trial, the investigators plan to share the results of the study both with scientific community and health professionals.
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adopting eMental Health IV: A Randomized Controlled Pilot Trial to Evaluate a Web-Based Mindful Parenting Post-Adoption Intervention
- ClinicalTrials.gov ID
- NCT07534111
- Acronym / sponsor ID
- pAM2C@WEB/2023.00703
- Conditions
- Parenting Stress, Positive Mental Health
- Keywords
- Parenting Stress, Positive Mental Health, Mindful Parenting Intervention, Adoptive Parents, Post-Adoption, Web-Based
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of CoimbraUniversity, hospital or other
- Study start
- 20 Apr 2026 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 16 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AdoptMindful2Care@Web Intervention | Experimental | Behavioral: pAdoptMindful2Care@WebAdoptive mothers and fathers will receive a structured 9-modules program based on mindful parenting principles, delivered through an online platform |
| Waiting list group | Other | Behavioral: pAdoptMindful2Care@WebAdoptive 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pAdoptMindful2Care@WebAdoptMindful2Care@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. | Behavioural | AdoptMindful2Care@Web Intervention, Waiting list group |
Primary outcome
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.
Changes from baseline in Positive Mental Health
Time frame: Baseline, 2, 3 and 4 months
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.
7 secondary outcomes
Changes from baseline in Mindful Parenting
Time frame: Baseline, 2, 3 and 4 months
Changes from baseline in Self-Compassion
Time frame: Baseline, 2, 3 and 4 months
Changes from baseline in Anxiety and Depressive Symptoms
Time frame: Baseline, 2, 3 and 4 months
Changes from baseline in Emotional Regulation
Time frame: Baseline, 2, 3 and 4 months
Changes from baseline in Children's Socio-Emotional Functioning
Time frame: Baseline, 2, 3 and 4 months
Acceptability of the intervention
Time frame: 2 months
Socioeconomic value of the intervention
Time frame: Baseline, 2 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: Undecided. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pAdoptMindful2Care@Web in people with Parenting Stress and Positive Mental Health, run by University of Coimbra at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ana Luz Chorão (+351 239 851 450, ana-lc@live.com.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from baseline in Parenting Stress (time frame: Baseline, 2, 3 and 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.