Dual-theoretical framework integrating the stress process model and family systems theory-based psychological intervention for caregivers of children and adolescents with mood disorders: study protocol for a randomized controlled trial

BackgroundGlobally, the prevalence of mood disorders among children and adolescents is rising, with the associated burden affecting patients, families, and society. Primary caregivers—mostly parents—experience sustained psychological stress and their mental health directly influences patients’ treatment adherence and clinical outcomes. Despite this, research on interventions has predominantly focused on the caregivers of children with autism spectrum disorder or attention-deficit/hyperactivity disorder. The caregivers of youth with mood disorders, particularly bipolar disorder, have been largely neglected. Moreover, theory-driven intervention programs for this population remain scarce.MethodsGrounded in the stress process model and family systems theory, we developed a comprehensive psychological health intervention for caregivers of children and adolescents with mood disorders and designed a randomized controlled trial to evaluate its effectiveness. A total of 216 caregivers will be recruited and randomly assigned at a 1:1 ratio to either the intervention group receiving the theory-based program or the control group receiving routine psychological nursing and health education. Outcomes include anxiety, depression, parenting stress, coping style, family functioning, and self-efficacy. These will be assessed at baseline, immediately post-intervention, and at 1-month follow-up. Semi-structured interviews will be conducted within 2 weeks post-intervention to capture caregivers’ lived experiences.DiscussionAdhering to the SPIRIT guidelines, this protocol targets primary caregivers of children and adolescents with mood disorders, a critically important yet under-recognized population. Based on evidence synthesis, five caregiver needs identified in the scoping review have been consolidated into four theory-based intervention targets within the SPM–FST framework: cognitive adjustment and belief restructuring, emotion regulation and stress coping, parent–child communication and family functioning enhancement, and group mutual support and social support. The intervention will be delivered via face-to-face group sessions, and its effectiveness will be evaluated using a mixed-methods approach combining quantitative scales and qualitative interviews. If shown to be effective and feasible, this program may provide empirical evidence for developing multi-level family caregiver support systems.Clinical trial registrationhttps://www.chictr.org.cn/, identifier ChiCTR2600123504.