Hearing LossNCT07278947
ACT-based Parenting Program for Caregivers of Children With Hearing Loss Post-cochlear: A Pilot Randomised Controlled Trial
A study of Hearing Loss and Stress, run by Second Xiangya Hospital of Central South University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing Loss, Stress, Depression, Anxiety
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- 28 Mar 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effects of an Online Psychoeducational and Psychotherapeutic Programme for Caregivers of Children With Hearing Loss Post-Cochlear Implantation: A Pilot Randomised Controlled Trial
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.
Read the 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
- Being tested
- ACT-based parenting program+usual care, Usual care
- Medical subject headings
- Hearing Loss, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACT-based parenting program+usual careBehavioural
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 careOther
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 group | Role | What they receive |
|---|---|---|
| ACT-based parenting program+usual care | Experimental | 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. Receives: Behavioral: ACT-based parenting program+usual care |
| Usual care | Active comparator | Parents will receive usual care delivered by otology nurses regarding post-cochlear implantation care instructions. Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parental Stress
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.
Measured: Change from baseline assessment to immediate post-intervention
Secondary outcomes (5)
Parental depressive symptoms
The Patient Health Questionnaire (PHQ-9, 9-item, 4-point Likert scale) will be used to assess the frequency of the parents experiencing depressive symptoms in the past two weeks. The Chinese version of the PHQ-9 has demonstrated good internal consistency reliability (Cronbach's alpha = 0.86) and test-retest correlation coefficient.
Measured: Change from baseline assessment to immediate post-intervention
Parental anxiety symptoms
The Generalized Anxiety Disorder-7 (GAD-7, 7-item, 4-point Likert scale) will be used to measure the severity of anxiety symptoms. The Chinese version of the GAD-7 demonstrated good reliability and validity with a Cronbach's coefficient of 0.91.
Measured: Change from baseline assessment to immediate post-intervention
Parental Psychological Flexibility
The PsyFlex (5-point Likert scale, 6 items) will be used to assess the six therapeutic processes in ACT, namely contacting the present moment, defusion, acceptance, self-as-context, values and committed action.
Measured: Change from baseline assessment to immediate post-intervention
Parenting competency
The Parenting Sense of Competence Scale (PSOC, 17-item, 6-point Likert scale) will be used to measure the level of parenting competency. The Chinese version of the PSOC demonstrate good reliability and validity with a Cronbach's coefficient of 0.87.
Measured: Change from baseline assessment to immediate post-intervention
Satisfaction of the intervention
The 18-item self-developed intervention satisfaction questionnaire and a group qualitative interview will be conducted 1-2 weeks after the end of the intervention. The satisfaction form, adopted from the 15-item self-reported Chinese Standardized Client Satisfaction Scale (C-SCS), utilized a 5-point Likert-scale to measure satisfaction with intervention design, duration, components, intervener performance, accessibility, needs fulfillment, and overall satisfaction.
Measured: This outcome will be assessed 1-2 weeks after the end of the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start28 Mar 2026 (estimated)
- Primary completion30 Jul 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- More trials run by Second Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two arm, pretest posttest, assessor blinded Randomised Controlled Trial (RCT)
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Xiangya Hospital of Central South University, The Third Xiangya Hospital of Central South University
- Responsible party
- Principal investigator, Jiao Xie, Second Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07278947
- Sponsor's protocol ID
- LYEC2025-0209
- Status last verified
- Mar 2026
- First submitted
- 1 Dec 2025
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Considering ethical reasons and participant privacy, we will not make individual participant data publicly available.
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Online Psychoeducational and Psychotherapeutic Programme for Caregivers of Children With Hearing Loss Post-Cochlear Implantation: A Pilot Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07278947
- Acronym / sponsor ID
- LYEC2025-0209
- Conditions
- Hearing Loss, Stress, Depression, Anxiety
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Second Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Collaborators
- Xiangya Hospital of Central South University, The Third Xiangya Hospital of Central South University
- Study start
- 28 Mar 2026 (estimated)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 12 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two arm, pretest posttest, assessor blinded Randomised Controlled Trial (RCT)
| Arm | Type | Receives |
|---|---|---|
| ACT-based parenting program+usual care | Experimental | Behavioral: ACT-based parenting program+usual careParents 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. |
| Usual care | Active comparator | Other: Usual careParents will receive usual care delivered by otology nurses regarding post-cochlear implantation care instructions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACT-based parenting program+usual careThe 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. | Behavioural | ACT-based parenting program+usual care |
| Usual careParents 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. | Other | Usual care |
Primary outcome
Parental Stress
Time frame: 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.
5 secondary outcomes
Parental depressive symptoms
Time frame: Change from baseline assessment to immediate post-intervention
Parental anxiety symptoms
Time frame: Change from baseline assessment to immediate post-intervention
Parental Psychological Flexibility
Time frame: Change from baseline assessment to immediate post-intervention
Parenting competency
Time frame: Change from baseline assessment to immediate post-intervention
Satisfaction of the intervention
Time frame: This outcome will be assessed 1-2 weeks after the end of the intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Individual participant dataSharing planned: No. Considering ethical reasons and participant privacy, we will not make individual participant data publicly available.
Related trials for Hearing Loss
RecruitingPhase 1/2
Anti-VEGF Gene Therapy Trial for Vestibular Schwannoma
Vestibular Schwannoma
Enrolling by invitationObservational study
Long Term Follow-up Study of AAVAnc80-hOTOF Gene Therapy
Otoferlin Gene-mediated Hearing Loss
Enrolling by invitationObservational study
Long Term Follow-up Study of AAVAnc80-antiVEGF Gene Therapy
Vestibular Schwannoma
Enrolling by invitationObservational study
Post-Market Registry Study for Vibrant Hearing Solutions
Conductive Hearing Loss, Mixed Hearing Loss
Active, not recruiting
Performance of a Remote Microphone Compared to Hearing Aids Alone
Hearing Loss, Bilateral Sensorineural
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study of Hearing Loss and Stress, run by Second Xiangya Hospital of Central South University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sini LI, PhD (86-17375843150, lisini_audrey@csu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parental Stress (time frame: Change from baseline assessment to immediate post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.