Via a cluster randomized control trial, this research helps to fill this gap by comparing the different intervention effects of Enhancing Contact Model (ECM), Psychoeducational Family Intervention (PFI) and Treat-As-Usual (TAU) among FCPWS on ameliorating caring burden in immediate, middle- and long-term follow-ups.
Methods: We conducted a parallel, three-arm, single-blinded, cluster randomized controlled trial in Xinjin district, Chengdu city in Southwest China. Townships were served as the unit of randomization with an allocation sequence of 1:1:1 ratio. Sample size was based on 90% power, a significance criterion of 0.05, 0.5 as the correlation among repeated measures, and 15% attrition rate. 253 FCPWS from 8 townships were randomly assigned to receive either ECM (cluster=3, n=90), PFI (cluster=2, n=81), or TAU (cluster=3, n=82). The intra-cluster correlation coefficient was 0.03. Most of the participants are married (83.40%), aged over 60 years old (54.94%), with a fulltime job (64.43%) and a secondary education (71.54%), and having less than 500 RMB income per month (49.01%).
Participants who were allocated to receive the ECM or PFI intervention were offered a 12-session peer group intervention weekly. The ECM intervention comprised both psychoeducational training on psychiatric literacy and burden-reducing via enhanced contact, while the PFI reflected a contemporary understanding of schizophrenia from bio-psycho-social perspectives, but focused on education and information. 12-item Zarit Burden Interview Short Form was used to measure caring burden. Independent and trained assessors were blind to the research design and completed the baseline and the follow-up assessments. Based on intention-to-treatment population, a mixed-effect model adjusting gender, marriage, relationship, employment, education, income, baseline interest and family size, was used to compare intervention difference at post-intervention, 3-month, and 9-month follow-up. The present model included random effects of intercept and slope, fixed effect, and the Group × Time interaction.
Results: Compared with participants in the TAU group, participants in the ECM group had statistically significantly lower ZBI-SF scores at both post-intervention and 3-month follow-up (p = 0.0059; p = 0.0257, respectively). PFI group did not show statistically significantly lower ZBI-SF scores than TAU in any timepoint. In the subgroup analysis, participants with higher monthly income (≥500 RMB), the ZBI-SF scores were statistically significantly lower in the ECM than those in PFI and TAU group (p < 0.0001; p = 0.0025, respectively). In non-spousal caregivers, the ZBI-SF scores were statistically significantly lower in the ECM than those in PFI and TAU group (p = 0.0007; p < 0.0001, respectively).
Conclusions and Implications: Findings highlight the effectiveness of ECM on reducing caring burden in non-Western societies. Authorities would benefit from the robust evidence when make policy and guideline to alleviate caring burden among FCPWS. Clinical professionals may consider highlighting enhancing contact model as a key concept in their practice, while future research needs to distill the “active ingredients” and refine the mechanism of ECM.