Parenting StressNCT07043660
Preliminary Efficacy of AdoptMindful2Care: A Mindful Parenting Post-adoption Intervention for Adoptive Parents
A study testing AdoptMindful2Care in people with Parenting Stress, run by University of Coimbra at 4 sites in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parenting Stress
- What is being tested?
- AdoptMindful2Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 4 sitesPortugal
- Study dates
- 30 Jun 2025to Feb 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
Portugal4 sites
Instituto da Segurança Social - Centro Distrital de Aveiro
Aveiro, 3804-504
Faculty of Psychology and Education Sciences, University of Coimbra
Coimbra, 3000-115
Instituto da Segurança Social, I.P.
Lisbon, 1050-063
Instituto da Segurança Social - Centro Distrital do Porto
Porto, 4199-001
About this study
Official title: Promoting Adoptive Parents' Well-being: A Randomized Controlled Pilot Trial to Evaluate a Mindful Parenting Post-adoption Intervention
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.
Read more
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).
- Conditions
- Parenting Stress
- Being tested
- AdoptMindful2Care
- Keywords
- parenting stress, mindful parenting intervention, adoptive parents, postadoption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdoptMindful2CareBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| AdoptMindful2Care Intervention | Experimental | Adoptive mothers and fathers will receive a structured 8-week group program based on mindful parenting principles, delivered in person during the study period Receives: Behavioral: AdoptMindful2Care |
| Waiting list group | Other | Adoptive mothers and fathers will not receive the intervention during the study period but will be offered and receive AdoptMindful2Care after the final follow-up assessment is completed. Receives: Behavioral: AdoptMindful2Care |
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 and 4 months
Secondary outcomes (8)
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 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 and 4 months
Changes from baseline in coparenting
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.
Measured: Baseline, 2 and 4 months
Changes from baseline in children's emotional and behavioral difficulties
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 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 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 and 4 months
Changes from baseline in mindfulness
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.
Measured: Baseline, 2 and 4 months
Acceptability of the intervention
Measured through specific questions (developed by the researchers) to assess acceptability.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2025
- Study start30 Jun 2025
- Primary completionJul 2026 (estimated)
- Study completionFeb 2027 (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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Coimbra
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação para a Ciência e a Tecnologia
- Responsible party
- Principal investigator, Bárbara Caetano, University of Coimbra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07043660
- Sponsor's protocol ID
- pAdoptMindful2Care/154436/2022
- Other IDs
- UI/BD/154436/2022, CEECIND/02463/2017
- Status last verified
- Feb 2026
- First submitted
- 20 Jun 2025
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- 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 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Adoptive Parents' Well-being: A Randomized Controlled Pilot Trial to Evaluate a Mindful Parenting Post-adoption Intervention
- ClinicalTrials.gov ID
- NCT07043660
- Acronym / sponsor ID
- pAdoptMindful2Care/154436/2022
- Conditions
- Parenting Stress
- Keywords
- parenting stress, mindful parenting intervention, adoptive parents, postadoption
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- University of CoimbraUniversity, hospital or other
- Collaborators
- Fundação para a Ciência e a Tecnologia
- Study start
- 30 Jun 2025 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 29 Jun 2025 (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.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AdoptMindful2Care Intervention | Experimental | Behavioral: AdoptMindful2CareAdoptive mothers and fathers will receive a structured 8-week group program based on mindful parenting principles, delivered in person during the study period |
| Waiting list group | Other | Behavioral: AdoptMindful2CareAdoptive mothers and fathers will not receive the intervention during the study period but will be offered and receive AdoptMindful2Care after the final follow-up assessment is completed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| AdoptMindful2CareAdoptMindful2Care 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. | Behavioural | AdoptMindful2Care Intervention, Waiting list group |
Primary outcome
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.
8 secondary outcomes
Changes from baseline in mindful parenting
Time frame: Baseline, 2 and 4 months
Changes from baseline in anxiety and depressive symptoms
Time frame: Baseline, 2 and 4 months
Changes from baseline in coparenting
Time frame: Baseline, 2 and 4 months
Changes from baseline in children's emotional and behavioral difficulties
Time frame: Baseline, 2 and 4 months
Changes from baseline in self-compassion
Time frame: Baseline, 2 and 4 months
Changes from baseline in emotional regulation
Time frame: Baseline, 2 and 4 months
Changes from baseline in mindfulness
Time frame: Baseline, 2 and 4 months
Acceptability of the intervention
Time frame: 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 9 Feb 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AdoptMindful2Care in people with Parenting Stress, run by University of Coimbra at 4 sites 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 3 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from baseline in parenting stress (time frame: Baseline, 2 and 4 months). 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 9 Feb 2026.