跳至主要内容
临床试验/NCT07534111
NCT07534111尚未招募不适用

Adopting eMental Health IV: A Randomized Controlled Pilot Trial to Evaluate a Web-Based Mindful Parenting Post-Adoption Intervention

University of Coimbra1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2026年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
90
试验地点
1
主要终点
Changes from baseline in Parenting Stress

研究概览

简要总结

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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)

研究组 & 干预措施

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

干预措施: pAdoptMindful2Care@Web (Behavioral)

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.

干预措施: pAdoptMindful2Care@Web (Behavioral)

结局指标

主要结局

Changes from baseline in Parenting Stress

时间窗: 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

时间窗: 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.

次要结局

  • Changes from baseline in Mindful Parenting(Baseline, 2, 3 and 4 months)
  • Changes from baseline in Self-Compassion(Baseline, 2, 3 and 4 months)
  • Changes from baseline in Anxiety and Depressive Symptoms(Baseline, 2, 3 and 4 months)
  • Changes from baseline in Emotional Regulation(Baseline, 2, 3 and 4 months)
  • Changes from baseline in Children's Socio-Emotional Functioning(Baseline, 2, 3 and 4 months)
  • Acceptability of the intervention(2 months)
  • Socioeconomic value of the intervention(Baseline, 2 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ana Luz Chorão

Master

University of Coimbra

研究点 (1)

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