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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSecond Xiangya Hospital of Central South University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • 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 intervention

    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.

Treatment groups

64 Participants
are divided into 2 treatment groups
Group A: ACT-based parenting program+usual careExperimental treatment 1 intervention
Group B: Usual careActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Change from baseline assessment to immediate post-intervention

Secondary outcomes

1

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.

Time frame
Change from baseline assessment to immediate post-intervention
2

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.

Time frame
Change from baseline assessment to immediate post-intervention
3

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.

Time frame
Change from baseline assessment to immediate post-intervention
4

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.

Time frame
Change from baseline assessment to immediate post-intervention

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Second Xiangya Hospital of Central South University

Lead sponsor

Xiangya Hospital of Central South University

Collaborator

The Third Xiangya Hospital of Central South University

Collaborator

This trial is not recruiting at the moment. You can still explore other options: