A newly announced pilot randomized controlled trial evaluates an ACT-based parenting program aimed at caregivers of children with hearing loss post-cochlear implant. The study, sponsored by the Second Xiangya Hospital alongside other medical institutions in China, seeks to address caregiver stress, anxiety, and depression. Not yet recruiting, this trial has the potential to inform better support systems and regulatory frameworks in pediatric hearing healthcare.
What Changed?
This new pilot study aims to address a critical care gap for caregivers of children with hearing loss who have received cochlear implants. Such caregivers often experience heightened levels of stress and psychological challenges, which can complicate their ability to support their children effectively. By introducing an Acceptance and Commitment Therapy (ACT)-based parenting intervention, coupled with usual care methods, this study aims to explore its effectiveness in improving caregiver mental health and parenting outcomes. Understanding these impacts could lead to broader adoption of targeted programs in pediatric audiology and regulatory shifts to meet caregiver needs comprehensively.
How Is the Study Designed?
The trial is structured as a pilot randomized controlled study. Participants, consisting of caregivers of post-cochlear implant children, will be randomized into two groups:
- Intervention Group: Receives the ACT-based parenting program in addition to usual care practices available to caregivers.
- Control Group: Receives usual care only, serving as the baseline for comparisons.
Key sponsor institutions include the Second Xiangya Hospital of Central South University and its associated medical affiliates, which bring established expertise in auditory medical care and mental health interventions. The trial aims to address conditions such as stress, anxiety, and depression, which are prevalent among this population.
Caregiver mental health outcomes, intervention adherence, and child developmental impacts will be quantitatively monitored using validated assessment tools. Ethical oversight and adherence to clinical trial regulatory requirements are central to the study’s framework.
What Are the Expected Outcomes?
The ACT-based parenting intervention is hypothesized to positively influence caregiver mental well-being by reducing stress and improving coping strategies. Indirectly, these changes are expected to enhance the quality of help and emotional support caregivers provide to their children with hearing loss.
If successful, this program could establish a more standardized, evidence-based approach to family care within the regulatory oversight of pediatric audiology services. The findings may lead to recommendations for policy shifts, particularly for caregivers in underserved populations managing post-cochlear implant adjustments. This research will contribute valuable data to inform future trials and program development globally.
FAQ
- What is the focus of the trial?
The trial investigates the effectiveness of an ACT-based parenting program in reducing caregiver stress, anxiety, and depression while supporting children with hearing loss post-cochlear implant. - Who is eligible to participate?
Caregivers of children with hearing loss who have undergone cochlear implantation are eligible. Recruitment criteria and details are yet to be confirmed. - When does recruitment start?
The trial is currently marked as “Not yet recruiting.” No specific recruitment timeline has been announced yet. - What institutions are overseeing the study?
The study is sponsored by the Second Xiangya Hospital of Central South University, along with Xiangya Hospital and The Third Xiangya Hospital.
Conclusion
The forthcoming ACT-based parenting program trial represents a critical effort to bridge gaps in caregiver mental health support for families managing pediatric cochlear implantation. This intervention aligns with broader regulatory efforts to valuate psychosocial care as a major component of auditory health management. Stakeholders are encouraged to stay updated as recruitment and preliminary findings emerge.
Disclaimer
This article is provided for informational purposes only and does not constitute legal, clinical, or regulatory advice. Professionals should consult relevant regulatory guidance and trial sponsors for further details.
Further Information
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07278947?term=medical+device