Background
Methods
Trial design
Participants
1. single parenthood 2. little support from spouse 3. little network support 4. relational problems 5. partner with mental health problems 6. children with poor health/handicaps/difficult temperament 7. changes in family structure/housing 8. two or more life events in the past two years 9. housing problems 10. poverty or debts 11. parents having been abused as a child 12. severe psychiatric symptoms 13. low compliance with psychiatric treatment 14. impulse control problems 15. alcohol or drug problems 16. low intelligence |
Interventions
Outcome measure
Resource usage and costing
Intervention costs
Costs related to utilization of services
Health service costs
Childcare costs
Inter-sectoral costs
Randomization
Data preparation for analysis
Analyses
The ICER is a ratio comparing the additional costs and effects in the experimental intervention with the control intervention. ICERs were calculated using the formula:
\( ICER=\frac{\left({C}_i\ \hbox{--}\ {C}_c\right)}{\left({E}_i\ \hbox{--}\ {E}_c\right)} \)
In this study, C represents the average total costs per family during the whole follow-up period of eighteen months, and E represents the mean difference between the HOME score at T2 and the HOME score at T0 in the PBCM condition (subscript i) and control condition (subscript c). Stochastic uncertainty in the data was dealt with using non-parametric bootstraps. By using the bootstrapping technique in Excel, the original sample was re-sampled, which resulted in 5000 simulated ICERs per scenario. These were plotted in cost-effectiveness planes (Fig. 2a,b,c). These planes provide a visual representation on the probability of PBCM being cost-effective in comparison with the control condition (the 0,0 coordinate) by showing the distribution of simulated ICERs across four quadrants: 1) the Northeast (NE) quadrant, which means that the intervention is more effective and more costly than CAU, 2) the Southeast (SE) quadrant, indicating that the intervention is more effective and less costly, 3) the Southwest (SW) quadrant, indicating that the intervention is less effective and less costly and 4) the Northwest (NW) quadrant, indicating that the intervention is less effective and more costly. An ICER in the SE and NW quadrant is negative, which represents the situation in which the intervention is either clearly dominant over (SE) or inferior to (NW) CAU. An ICER in the SW or NE quadrant is positive, which means, from a cost-effectiveness perspective, that the intervention is more favorable than the control condition only when the ICER is lower than the maximum willingness to pay (WTP max) per unit effect. The WTP max is the maximum expense a society is willing to pay for better outcomes (parenting quality, in this study). Since no acknowledged threshold, i.e. WTP max, is available for the HOME outcome measure, a CEAC was created for each perspective (Fig. 2d,e,f). The CEAC shows the likelihood of PBCM being favorable over the control intervention for several different hypothetical maximum WTPs. |
Sensitivity analysis
Results
Participant flow
Baseline data
Variable | Experimental Group (n = 49) | Control Group (n =50) | Difference (df) |
P
| ||||||
---|---|---|---|---|---|---|---|---|---|---|
Primary patient and family structure | χ2 = 4.45 (1) | 0.035ab* | ||||||||
Mother/single, N (%) | 28 | (57 %) | 18 | (36 %) | ||||||
Mother/two-parent family, N (%) | 15 | (31 %) | 26 | (52 %) | ||||||
Father/two-parent family, N (%) | 2 | (4 %) | 2 | (4 %) | ||||||
Mother and father, N (%) | 4 | (8 %) | 4 | (8 %) | ||||||
Diagnosis | Mothers | Fathers | Mothers | Fathers | χ2 = 0.98 (2) | 0.976b c | ||||
Depressive and anxiety disorders, N (%) | 36 | (77 %) | 4 | (67 %) | 36 | (75 %) | 4 | (67 %) | ||
Other Axis I disorders, N (%) | 8 | (17 %) | 2 | (33 %) | 9 | (19 %) | 2 | (33 %) | ||
Personality disorders, N (%) | 3 | (7 %) | - | - | 3 | (6 %) | - | - | ||
Comorbidity, severity and chronicity | ||||||||||
Comorbidity, N (%) | 20 | (43 %) | 3 | (50 %) | 25 | (52 %) | 2 | (33 %) | χ2 = 0.87 (1) | 0.352b |
Severity of illness CGI, mean (sd) | 4.53 | (1.10) | 4.38 | (0.50) | 4.51 | (0.92) | 4.00 | (1.0) | t = 0.79 (93) | 0.917b |
Chronic course of illness > 2 years, N (%) | 18 | (38 %) | 2 | (33 %) | 24 | (48 %) | 2 | (33 %) | χ2 = 0.68 (1) | 0.257b |
Ethnicity | χ2 = 7.30 (1) | 0.007* | ||||||||
Ethnic minority, N (%) | 39 | (80 %) | 27 | (54 %) | ||||||
Morocco, N (%) | 11 | (22 %) | 8 | (16 %) | ||||||
Turkey, N (%) | 9 | (18 %) | 6 | (12 %) | ||||||
Surinam, N (%) | 8 | (16 %) | 6 | (12 %) | ||||||
Netherlands Antilles, N (%) | 5 | (10 %) | 2 | (4 %) | ||||||
Other country, N (%) | 6 | (12 %) | 5 | (10 %) | ||||||
Children | ||||||||||
Number, mean (sd) | 2.10 | (0.98) | 2.16 | (1.02) | t = -0.29 (97) | 0.774 | ||||
Children 0-3 years (N) | 27 | (82 %) | 35 | (90 %) | χ2 = 2.01 (3) | 0.570 | ||||
Children 4-12 years (N) | 61 | (24 %) | 63 | (34 %) | χ2 = 2.24 (3) | 0.524 | ||||
Children 13-20 years (N) | 13 | (18 %) | 9 | (14 %) | χ2 = 0.77 (2) | 0.682 | ||||
Male gender index child, N (%) | 25 | (51 %) | 30 | (60 %) | χ2 = 0.81 (1) | 0.619 | ||||
Age index child, mean (sd) | 6.53 | (2.19) | 5.64 | (1.76) | t = 2.25 (97) | 0.027* | ||||
HOME total score at baseline, mean (sd) | 48.59 | (10.79) | 51.38 | (9.05) | t = -1.40 (97) | 0.166 | ||||
Costs at baseline | ||||||||||
Healthcare costs (Euros, 2012) | 5.156 | 6.275 | ||||||||
Childcare costs (Euros, 2012) | 2.687 | 3.751 | ||||||||
Inter-sectoral costs (Euros, 2012) | 1.411 | 1.009 | ||||||||
Other | ||||||||||
Number of risk factors, mean (sd) | 5.20 | (1.38) | 5.02 | (1.48) | t = 0.64 (97) | 0.524 | ||||
Receiving social benefits, N (%) | 23 | (47 %) | 15 | (30 %) | χ2 = 3.00 (1) | 0.083 |
Costs
Follow-up T0-T1, (first 9 months) | Follow-up T1-T2, (10 to 18 months) | Total T0-T2, (full 18 months) | |||||
---|---|---|---|---|---|---|---|
PBCM | Control | PBCM | Control | PBCM | Control | ||
Intervention Costs | € 1,685 | € 229 | |||||
Service Costs | Healthcare costs | € 5,875 | € 6,528 | € 5,452 | € 4,462 | € 11,327 | € 10,990 |
Mental healthcare | € 2,650 | € 1,963 | € 1,861 | € 1,340 | € 4,511 | € 3,303 | |
Primary care (other) | € 525 | € 715 | € 734 | € 391 | € 1,259 | € 1,106 | |
Secondary care (other) | € 1,044 | € 1,820 | € 1,233 | € 857 | € 2,277 | € 2,677 | |
Preventive family support | € 1,399 | € 1,908 | € 1,350 | € 1,651 | € 2,749 | € 3,559 | |
Specialized child services | € 257 | € 122 | € 274 | € 223 | € 531 | € 345 | |
Total healthcare perspective | € 13,012 | € 11,219 | |||||
Childcare costs | € 2,304 | € 3,010 | € 2,401 | € 2,750 | € 4,705 | € 5,760 | |
Informal childcare | € 1,115 | € 1,341 | € 1,169 | € 1,286 | € 2,284 | € 2,627 | |
Professional childcare | € 1,189 | € 1,669 | € 1,232 | € 1,464 | € 2,421 | € 3,133 | |
Total social care perspective | € 17,717 | € 16,979 | |||||
Costs outside care sector | € 1,156 | € 522 | € 930 | € 1,708 | € 2,086 | € 2,230 | |
Educational sector | € 685 | € 107 | € 553 | € 1,302 | € 1,238 | € 1,409 | |
Criminal justice sector | € 238 | € 38 | € 52 | € 169 | € 290 | € 207 | |
Debt restructuring | € 233 | € 377 | € 325 | € 237 | € 558 | € 614 | |
Total societal perspective | € 19,805 | € 19,209 |
Incremental costs
Perspectivea | Condition | Costs, €b | Effectc | ICERd | Northeast | Northwest (inferior) | Southwest | Southeast (dominant) |
---|---|---|---|---|---|---|---|---|
Base case scenario | ||||||||
(imputed data, including cost outliers
e
)
| ||||||||
Healthcare | Control (n = 50) | 11,219 | -1.89 | |||||
PBCM (n = 49) | 13,012 | 1.93 | 461 | 78 % | 2 % | 1 % | 20 % | |
Social care | Control (n = 50) | 16,979 | -1.89 | |||||
PBCM (n = 49) | 17,717 | 1.93 | 215 | 60 % | 1 % | 1 % | 37 % | |
Societal | Control (n = 50) | 19,209 | -1.89 | |||||
PBCM (n = 49) | 19,805 | 1.93 | 175 | 59 % | 1 % | 1 % | 39 % | |
Alternative scenario A | ||||||||
(imputed data, excluding cost outliers)
| ||||||||
Healthcare | Control (n = 47) | 8,969 | -1.28 | |||||
PBCM (n = 47) | 11,564 | 1.70 | 776 | 90 % | 6 % | 0 % | 4 % | |
Social care | Control (n = 47) | 14,422 | -1.40 | |||||
PBCM (n = 47) | 16,138 | 1.70 | 517 | 81 % | 4 % | 1 % | 15 % | |
Societal | Control (n = 47) | 16,634 | -1.82 | |||||
PBCM (n = 47) | 18,194 | 1.70 | 410 | 76 % | 3 % | 1 % | 21 % | |
Alternative scenario B | ||||||||
(complete cases, including cost outliers)
| ||||||||
Healthcare | Control (n = 41) | 11,475 | -2.06 | |||||
PBCM (n = 41) | 13,480 | 2.34 | 446 | 79 % | 1 % | 0 % | 20 % | |
Social care | Control (n = 41) | 17,765 | -2.06 | |||||
PBCM (n = 41) | 18,375 | 2.34 | 133 | 58 % | 1 % | 1 % | 40 % | |
Societal | Control (n = 41) | 20,242 | -2.06 | |||||
PBCM (n = 41) | 19,621 | 2.34 | dominantf | 41 % | 0 % | 1 % | 58 % | |
Alternative scenario C | ||||||||
(imputed data, including cost outliers, PBCM-families who received the intervention)
| ||||||||
Healthcare | Control (n = 48) | 10,933 | -1.65 | |||||
PBCM (n = 38) | 14,579 | 2.24 | 897 | 93 % | 2 % | 0 % | 5 % | |
Social care | Control (n = 48) | 16,140 | -1.65 | |||||
PBCM (n = 38) | 19,522 | 2.24 | 843 | 90 % | 2 % | 0 % | 8 % | |
Societal | Control (n = 48) | 18,458 | -1.65 | |||||
PBCM (n = 38) | 20,736 | 2.24 | 558 | 79 % | 2 % | 0 % | 20 % | |
Alternative scenario D | ||||||||
(imputed data, including cost outliers, mean difference adjustment)
| ||||||||
Healthcare | Control (n = 50) | 8,981 | -1.89 | |||||
PBCM (n = 49) | 13,012 | 1.93 | 1,031 | 95 % | 2 % | 0 % | 3 % | |
Social care | Control (n = 50) | 12,613 | -1.89 | |||||
PBCM (n = 49) | 17,717 | 1.93 | 1,313 | 96 % | 2 % | 0 % | 2 % | |
Societal | Control (n = 50) | 15,647 | -1.89 | |||||
PBCM (n = 49) | 19,804 | 1.93 | 1,059 | 92 % | 2 % | 0 % | 6 % |