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临床试验/NCT07043660
NCT07043660进行中(未招募)不适用

Promoting Adoptive Parents' Well-being: A Randomized Controlled Pilot Trial to Evaluate a Mindful Parenting Post-adoption Intervention

University of Coimbra4 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2025年6月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
78
试验地点
4
主要终点
Changes from baseline in parenting stress

研究概览

简要总结

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).

研究设计

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

入排标准

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

入选标准

  • •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.

排除标准

  • •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.

研究组 & 干预措施

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

干预措施: AdoptMindful2Care (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 after the final follow-up assessment is completed.

干预措施: AdoptMindful2Care (Behavioral)

结局指标

主要结局

Changes from baseline in parenting stress

时间窗: 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.

次要结局

  • Changes from baseline in mindful parenting(Baseline, 2 and 4 months)
  • Changes from baseline in anxiety and depressive symptoms(Baseline, 2 and 4 months)
  • Changes from baseline in coparenting(Baseline, 2 and 4 months)
  • Changes from baseline in children's emotional and behavioral difficulties(Baseline, 2 and 4 months)
  • Changes from baseline in self-compassion(Baseline, 2 and 4 months)
  • Changes from baseline in emotional regulation(Baseline, 2 and 4 months)
  • Changes from baseline in mindfulness(Baseline, 2 and 4 months)
  • Acceptability of the intervention(2 months)

研究者

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

Bárbara Caetano

Principal Investigator

University of Coimbra

研究点 (4)

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