Effects of an Online Psychoeducational and Psychotherapeutic Programme for Caregivers of Children With Hearing Loss Post-Cochlear Implantation: A Pilot Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 64
- 主要终点
- Parental Stress
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
Eligible parents consenting to participate will be randomly assigned to either the Intervention (ACT-based parenting program) or Control (usual-care) Group in a 1:1 ratio, using the permuted block size of 4 through sequentially numbered, opaque and sealed envelopes with number cards (1=intervention, 2=control). A separate set of random numbers, concealed from the research team and RAs, will be generated by a statistician. Clerical staff uninvolved in the project will administer the randomisation. The research assistant (RA-1), blinded to subject selection, will open the envelopes only after informed consent and baseline assessments are completed. The research assistant (RA-2) is also blinded to group assignments and will conduct assessments/evaluations.
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
- •Mandarin-speaking Chinese residents aged ≥18 years.
- •Their child is scheduled to undergo cochlear implant surgery within the next month or has undergone cochlear implant surgery within the past month.
- •Living with their child with hearing loss who uses (or will use) a cochlear implant.
- •Primary caregiver responsible for the child's daily care.
- •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.
排除标准
- •Parents with cognitive deficiency, severe mental illness and/or disability conditions that interfere with their ability to comprehend the programme's content.
- •Current substance or alcohol dependence.
- •Pregnancy or postpartum period (<6 months).
- •Participation in any ACT-based intervention within the past six months.
研究组 & 干预措施
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.
干预措施: ACT-based parenting program+usual care (Behavioral)
Usual care
Parents will receive usual care delivered by otology nurses regarding post-cochlear implantation care instructions.
干预措施: Usual care (Other)
结局指标
主要结局
Parental Stress
时间窗: Change from baseline assessment to immediate post-intervention
The Parental Stress Scale (PSS, 18-item, 5-point scale) will assess parenting stress. A higher score represents a higher level of parental stress. The Chinese version of the PSS has demonstrated acceptable psychometric properties and is therefore suitable for use by researchers to assess the parental stress levels of Chinese parents.
次要结局
- Parental depressive symptoms(Change from baseline assessment to immediate post-intervention)
- Parental anxiety symptoms(Change from baseline assessment to immediate post-intervention)
- Parental Psychological Flexibility(Change from baseline assessment to immediate post-intervention)
- Parenting competency(Change from baseline assessment to immediate post-intervention)
- Satisfaction of the intervention(This outcome will be assessed 1-2 weeks after the end of the intervention.)
研究者
Jiao Xie
Associate Chief Nurse
Second Xiangya Hospital of Central South University
