ACT-based Parenting Program for Caregivers of Children With Hearing Loss Post-cochlear: A Pilot Randomised Controlled Trial

Sponsor
Second Xiangya Hospital of Central South University
Study ID
NCT07278947
Status
Not Yet Recruiting

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Conditions

  • Depression, Anxiety
  • Hearing Loss
  • Stress

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ACT-based parenting program+usual care — BEHAVIORAL
    The ACT-based parenting program integrates two complementary components: (1) targeted psychoeducation on post-CI care (device use and troubleshooting, home-based auditory rehabilitation, realistic progress monitoring, school and social participation, communication strategies, and navigation of rehabilitation services); and (2) brief, skills-focused psychotherapeutic content grounded in ACT principles to enhance psychological flexibility (e.g., present-moment awareness, defusion from difficult thoughts, acceptance of difficult emotions and sensations, values clarification, and committed action in daily caregiving). By combining condition-specific knowledge with process-based skills, the intervention is designed to address both informational needs and core psychopathological processes that perpetuate caregiver distress.
  • Usual care — OTHER
    Parents in the control arm will receive usual care delivered by otology nurses covering post-cochlear implantation care instructions (e.g., device safety, basic troubleshooting, follow-up schedules) and will have access to standard rehabilitation services as per clinic routines. After final assessments, waitlist participants may be offered access to intervention materials where appropriate.

Study Details

The purpose of the proposed pilot randomized controlled design study is to evaluate the feasibility, acceptability, and potential effectiveness of using a videoconferencing-based individual Acceptance and Commitment Therapy (ACT) approach to enhance the mental well-being and parenting competence of parents of children with hearing loss post-cochlear implantation over a three-month period after the intervention has taken place.

Key Dates

First listed
Dec 12, 2025
Start date
Mar 28, 2026
Status verified
Mar 2026
Primary completion
Jul 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
64 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: ACT-based parenting program+usual care
    Parents will receive 6 ACT-based parenting program sessions, one weekly session, 45-60 mins per session. These sessions will be one-on-one, conducted via video conferencing.
  • Active Comparator: Usual care
    Parents will receive usual care delivered by otology nurses regarding post-cochlear implantation care instructions.

Primary Outcome Measure

Parental Stress [ Time Frame: Change from baseline assessment to immediate post-intervention ]

Central Contacts

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