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

NCT ID: NCT07278947

Last Updated: 2025-12-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-15
• Study Completion Date: 2026-05-31

Brief Summary

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.

Detailed Description

Caregivers of children with hearing loss post-cochlear implantation (CI), experience sustained caregiving demands that place them at elevated risk for stress, anxiety, depressive symptoms, and reduced family functioning. The postoperative journey commonly involves intensive device mapping, auditory-verbal therapy, daily home-based training, and frequent medical or rehabilitation appointments. These demands, coupled with uncertainty about the child's auditory, speech, and psychosocial outcomes, can erode caregiver well-being and strain family routines. Evidence across populations indicates that psychoeducational and psychotherapeutic interventions can improve caregiver mental health and parenting efficacy by providing knowledge, skills, and strategies that enhance coping and resilience.

Acceptance and Commitment Therapy (ACT) and related third-wave approaches have shown benefits for parents of children with chronic conditions by increasing psychological flexibility-an empirically supported process linked to improved mental health and adaptive caregiving. However, prior trials in similar caregiver populations have sometimes yielded modest effect sizes, in part due to high resource requirements (e.g., reliance on extensively trained therapists) and insufficient focus on the most impaired transdiagnostic processes (e.g., cognitive fusion, experiential avoidance, values-behavior disconnect). In addition, access barriers (time, travel, childcare) limit uptake of in-person programs, especially for families navigating intensive post CI rehabilitation schedules.

This pilot randomized controlled trial (RCT) will evaluate the feasibility, acceptability, and preliminary effectiveness of an online psychoeducational and psychotherapeutic programme tailored for caregivers of children with hearing loss following cochlear implantation. The programme integrates two complementary components: (1) targeted psychoeducation on post CI care (device use and troubleshooting, auditory rehabilitation at home, 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.

The programme will be delivered via secure videoconferencing in a structured, time limited format to reduce burden and improve accessibility. Sessions will include didactic micro modules, guided experiential exercises (e.g., mindfulness, values mapping, defusion techniques), and applied practice tied to real world caregiving tasks (e.g., integrating values into daily listening practice, using brief acceptance/defusion skills during child resistance to wear time, and problem solving around school or therapy transitions). Between-session activities will reinforce learning through short videos, worksheets, and practice logs. Content will be developmentally and culturally adapted for families of children using CIs, with attention to diverse communication modalities and family preferences.

Participants will be randomly assigned to the online programme or a waitlist control. Outcome assessments will occur at baseline (pre intervention) and immediately post intervention. Primary feasibility and acceptability metrics will include recruitment, retention, session attendance, completion of between session activities, and participant-rated satisfaction and perceived usefulness. Preliminary effectiveness outcomes will focus on caregiver mental health and functioning (e.g., stress, anxiety/depressive symptoms, psychological flexibility, and parenting self efficacy). Exploratory outcomes will include family functioning, adherence to home auditory verbal practice, and caregiver reported child participation in everyday listening and communication activities.

We hypothesize that the online programme will be feasible and acceptable to caregivers and will yield greater improvements than usual-care-only control in caregiver mental health, psychological flexibility, and parenting self-efficacy from baseline to post intervention. By using a brief, process based approach and remote delivery, the intervention aims to lessen reliance on scarce specialist time, reduce participation barriers, and target the mechanisms most closely linked to caregiver distress. Findings from this pilot will inform refinement of content, dosing, and implementation strategies, and will provide effect size estimates to power a future full scale RCT.

Conditions

Hearing Loss; Stress; Depression, Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

ACT-based parenting program+usual care

Intervention Type: 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

Parents will receive usual care delivered by otology nurses regarding post-cochlear implantation care instructions.

Group Type: ACTIVE_COMPARATOR

Usual care

Intervention Type: 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.

Interventions

ACT-based parenting program+usual care

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.

Intervention Type: BEHAVIORAL

Usual care

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Mandarin-speaking Chinese residents aged ≥18 years.

2. Their child is scheduled to undergo cochlear implant surgery within the next month or has undergone cochlear implant surgery within the past month.

3. Living with their child with hearing loss who uses (or will use) a cochlear implant.

4. Primary caregiver responsible for the child's daily care.

5. Has reliable internet access via a computer and/or smartphone for video-conferencing (e.g., TenCent Meeting, Zoom) and is willing to maintain access for the duration of the intervention.

Exclusion Criteria

1. Parents with cognitive deficiency, severe mental illness and/or disability conditions that interfere with their ability to comprehend the programme's content.

2. Current substance or alcohol dependence.

3. Pregnancy or postpartum period (<6 months).

4. Participation in any ACT-based intervention within the past six months.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xiangya Hospital of Central South University

OTHER

Sponsor Role: collaborator

The Third Xiangya Hospital of Central South University

OTHER

Sponsor Role: collaborator

Second Xiangya Hospital of Central South University

OTHER

Sponsor Role: lead

Responsible Party

Jiao Xie

Associate Chief Nurse

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Sini LI, PhD

Role: CONTACT

lisini_audrey@csu.edu.cn

86-17375843150

Other Identifiers

LYEC2025-0209

Identifier Type: -

Identifier Source: org_study_id