Preliminary Efficacy of the AdoptMindful2Care@Web: A Web-Based Mindful Parenting Post-Adoption Intervention for Adoptive Parents

Official title

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

Overview

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).

Interventions

• Behavioral pAdoptMindful2Care@Web
  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

Primary outcome measures

• Changes from baseline in Parenting Stress [Time frame: Baseline, 2, 3 and 4 months]
• Changes from baseline in Positive Mental Health [Time frame: Baseline, 2, 3 and 4 months]

Secondary outcome measures (7)

• 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]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Prevention

Study locations

Portugal · 1 center

• Faculty of Psychology and Education Sciences, University of Coimbra — Coimbra

Identifiers

NCT: NCT07534111 · pAM2C@WEB/2023.00703 · 2023.00703.BD · CEECIND/02463/2017 · FCG/Growing Minds 294688

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗