Evaluation of a Family-Based Intervention Program for Children of Mentally Ill Parents: Study Protocol for a Randomized Controlled Multicenter Trial

Silke Wiegand-Grefe, Bonnie Filter, Mareike Busmann, Reinhold Kilian, Klaus-Thomas Kronmüller, Martin Lambert, Christine Norra, Kai von Klitzing, Kurt Albermann, Sibylle Maria Winter, Anne Daubmann, Karl Wegscheider, Angela Plass-Christl, Silke Wiegand-Grefe, Bonnie Filter, Mareike Busmann, Reinhold Kilian, Klaus-Thomas Kronmüller, Martin Lambert, Christine Norra, Kai von Klitzing, Kurt Albermann, Sibylle Maria Winter, Anne Daubmann, Karl Wegscheider, Angela Plass-Christl

Abstract

Background: Children of mentally ill parents have a three to seven times higher risk of developing mental disorders compared to the general population. For this high-risk group, specialized prevention and intervention programs have already been developed. However, there has been insufficient sytematic evaluation to date. Moreover, effectiveness and the cost-effectiveness data of the respective programs until today is very scarce and at the same time constitutes the pre-condition for the program's implementation into regular health care. Methods: The study consists of a two-group randomized controlled multicenter trial conducted at seven study sites throughout Germany and Switzerland. Participants are families with mentally ill parents and their children aged from 3 to 19 years. The intervention comprises 6 to 8 semi-structured sessions over a period of about 6 months. Topics discussed in the intervention include parental mental illness, coping, family relations and social support. Families in the control condition will receive treatment as usual. The children's mental health, assessed using the K-SADS-PL by blinded external raters will constitute the primary efficacy outcome. Further outcomes will be assessed from the parents' as well as from the children's perspectives. Participants are investigated at baseline, 6, 12, and 18 months after baseline assessment. In addition to the assessment of various psychosocial outcomes, a comprehensive health-economic evaluation will be performed. Discussion: This paper describes the evaluation of a family-based intervention program for children of mentally ill parents (CHIMPs) in the regular health care system in Germany and Switzerland. A methodically sophisticated study design has been developed to reflect the complexity of the actual health care situation. This trial will contribute to the regular health care for the high-risk group of children of mentally ill parents. Clinical Trial Registration: www.ClinicalTrials.gov, identifier NCT02308462; German Clinical Trials Register: DRKS00006806.

Keywords: children of mentally ill parents; evaluation; family intervention; multicenter trial; randomized controlled trial.

Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Copyright © 2021 Wiegand-Grefe, Filter, Busmann, Kilian, Kronmüller, Lambert, Norra, von Klitzing, Albermann, Winter, Daubmann, Wegscheider and Plass-Christl.

Figures

Figure 1
Figure 1
Overview of the CHIMPs study design.

References

    1. Leijdesdorff S, van Doesum KTM, Popma A, Klaassen R, van Amelsvoort T. Prevalence of psychopathology in children of parents with mental illness and/or addiction: an up to date narrative review. Curr Opin Psychiatry. (2017) 30:312–7. 10.1097/YCO.0000000000000341
    1. Plass-Christl A, Haller A-C, Otto C, Barkmann C, Wiegand-Grefe S, Holling H, et al. . Parents with mental health problems and their children in a German population based sample: results of the BELLA study. PLoS ONE. (2017) 12:e0180410. 10.1371/journal.pone.0180410
    1. Wiegand-Grefe S, Geers P, Plaß A, Petermann F, Riedesser P. Kinder psychisch kranker Eltern: Zusammenhänge zwischen subjektiver elterlicher Beeinträchtigung und psychischer Auffälligkeit der Kinder aus Elternsicht (Children of mentally ill parents: associations between subjective parental impairment and psychological problems of the children). Kindheit und Entwicklung. (2009) 18:111–21. 10.1026/0942-5403.18.2.111
    1. van Santvoort F, Hosman CMH, Janssens MAMJ, van Doesum KTM, Reupert A, Van Loon ALM. The impact of various parental mental disorders on children's diagnoses: a systematic review. Clin Child Fam Psychol Rev. (2015) 18:281–99. 10.1007/s10567-015-0191-9
    1. Kilian R, Losert C, Park A, McDaid D, Knapp M. Cost-effectiveness analysis in child and adolescent mental health problems—an updated review of literature. Int J Ment Health Promot. (2010) 12:45–57. 10.1080/14623730.2010.9721825
    1. Kilian R, Mueller-Stierlin A, Herder K, Helmbrecht MJ, Walendzik J, Holzmann M, et al. The effectiveness and cost-effectiveness of an integrated mental health care programme in comparison to standard psychiatric care in Germany. J Ment Health Policy Econ. (2017) 20:S18–9.
    1. Siegenthaler E, Munder T, Egger M. Effect of preventive interventions in mentally ill parents on the mental health of the offspring: systematic review and meta-analysis. J Am Acad Child Adolesc Psychiatry. (2012) 51:8–17.e8. 10.1016/j.jaac.2011.10.018
    1. Reupert AE, Maybery DJ, Kowalenko MN. Children whose parents have a mental illness: prevalence, need and treatment. MJA Open. (2012) 1(Suppl. 1):7–9. 10.5694/mjao11.11200
    1. Caspi A, Sugden K, Moffitt TE, Taylor A, Craig IW, Harrington H, et al. . Influence of life stress on depression: moderation by a polymorphism in the 5-HTT gene. Science. (2003) 301:386–9. 10.1126/science.1083968
    1. Assary E, Vincent JP, Keers R, Pluess M. Gene-environment interaction and psychiatric disorders: review and future directions. Semin Cell Dev Biol. (2018) 77:133–43. 10.1016/j.semcdb.2017.10.016
    1. Krumm S, Becker T, Wiegand-Grefe S. Mental health services for parents affected by mental illness. Curr Opin Psychiatry. (2013) 26:362–8. 10.1097/YCO.0b013e328361e580
    1. Wiegand-Grefe S, Sell M, Filter B, Plass-Christl A. Family functioning and psychological health of children with mentally ill parents. Int J Environ Res Public Health. (2019) 16:1278. 10.3390/ijerph16071278
    1. Jozefiak T, Greger HK, Koot HM, Klockner CA, Wallander LJ. The role of family functioning and self-esteem in the quality of life of adolescents referred for psychiatric services: a 3-year follow-up. Qual Life Res. (2019) 28:2443–52. 10.1007/s11136-019-02197-7
    1. Collishaw S, Hammerton G, Mahedy L, Sellers R, Owen MJ, Craddock N, et al. . Mental health resilience in the adolescent off spring of parents with depression: a prospective longitudinal study. Lancet Psychiatry. (2016) 3:49–57. 10.1016/s2215-0366(15)00358-2
    1. Brent DA, Brunwasser SM, Hollon SD, Weersing VR, Clarke GN, Dickerson JF, et al. . Effect of a cognitive-behavioral prevention program on depression 6 years after implementation among at-risk adolescents a randomized clinical trial. JAMA Psychiatry. (2015) 72:1110–8. 10.1001/jamapsychiatry.2015.1559
    1. Aktar E, Qu J, Lawrence PJ, Tollenaar MS, Elzinga BM, Bogels MS. Fetal and infant outcomes in the offspring of parents with perinatal mental disorders: earliest influences. Front Psychiatry. (2019) 10:391. 10.39110.3389/fpsyt.2019.00391
    1. Reedtz C, Lauritzen C, Stover YV, Freili JL, Rognmo K. Identification of children of parents with mental illness: a necessity to provide relevant support. Front Psychiatry. (2019) 9:728. 10.3389/fpsyt.2018.00728
    1. Tabak I, Zablocka-Zytka L, Ryan P, Poma SZ, Joronen K, Vigano G, et al. . Needs, expectations and consequences for children growing up in a family where the parent has a mental illness. Int J Ment Health Nurs. (2016) 25:319–29. 10.1111/inm.12194
    1. Lauritzen C, Reedtz C, Rognmo K, Nilsen MA, Walstad A. Identification of and support for children of mentally ill parents: a 5 year follow-up study of adult mental health services. Front Psychiatry. (2018) 9:507. 10.3389/fpsyt.2018.00507
    1. Reupert AE, Cuff R, Drost L, Foster K, van Doesum KTM, van Santvoort F. Intervention programs for children whose parents have a mental illness: a review. MJA Open. (2012) 1(Suppl. 1):18–22. 10.5694/mjao11.11145
    1. Fraser C, James EL, Anderson K, Lloyd D, Judd F. Intervention programs for children of parents with a mental illness: a critical review. Int J Ment Health Promot. (2006) 8:9–20. 10.1080/14623730.2006.9721897
    1. Bee P, Bower P, Byford S, Churchill R, Calam R, Stallard P, et al. . The clinical effectiveness, cost-effectiveness and acceptability of community-based interventions aimed at improving or maintaining quality of life in children of parents with serious mental illness: a systematic review. Health Technol Assess. (2014) 18:1–250. 10.3310/hta18080
    1. Thanhauser M, Lemmer G, de Girolamo G, Christiansen H. Do preventive interventions for children of mentally ill parents work? Results of a systematic review and meta-analysis. Curr Opin Psychiatry. (2017) 30:283–99. 10.1097/YCO.0000000000000342
    1. Hefti S, Kölch M, D Gallo A, Stierli R, Roth B, Schmid M. Welche Faktoren beeinflussen, ob psychisch belastete Kinder mit einem psychisch kranken Elternteil Hilfen erhalten? Kindheit und Entwicklung. (2016) 25:89–99. 10.1026/0942-5403/a000193
    1. Schulze LN, Klinger-Konig J, Stolzenburg S, Wiese J, Speerforck S, Van der Auwera-Palitschka S, et al. . Shame, self-identification with having a mental illness, and willingness to seek help in northeast Germany. Psychiatry Res. (2020) 285:112819. 10.1016/j.psychres.2020.112819
    1. Wiegand-Grefe S, Halverscheid S, Plass A. Kinder und ihre psychisch kranken Eltern. Familienorientierte Prävention—Der CHIMPs-Beratungsansatz. Göttingen: Hogrefe; (2011).
    1. Cierpka M, Massing A, Reich G. Praxis der Psychoanalytischen Familien- und Paartherapie. Stuttgart: Kohlhammer; (2007).
    1. Wiegand-Grefe S. Belastungen von Kindern psychisch kranker Eltern. Psychosoziale Folgen und Präventionsbedarf. Der Neurologe und Psychiater. (2010) 11:42–47.
    1. Beardslee WR, Gladstone TRG, Wright EJ, Cooper BA. A family-based approach to the prevention of depressive symptoms in children at risk: evidence of parental and child change. Pediatrics. (2003) 112:e119–31. 10.1542/peds.112.2.e119
    1. Beardslee WR, Wright EJ, Gladstone TRG, Forbes P. Long-term effects from a randomized trial of two public health preventive interventions for parental depression. J Fam Psychol. (2007). 10.1037/0893-3200.21.4.703.supp
    1. Wiegand-Grefe S, Cronemeyer B, Plass A, Schulte-Markwort M, Petermann F. Psychische Auffälligkeiten von Kindern psychisch kranker Eltern im Perspektivenvergleich: Effekte einer manualisierten Familienintervention (Comparison of mental abnormalities in children of mentally ill parents from different points of view: effects of a manualized family intervention). Kindheit und Entwicklung. (2013) 22:31–40. 10.1026/0942-5403/a000096
    1. Wiegand-Grefe S, Werkmeister S, Bullinger M, Plass A, Petermann F. Gesundheitsbezogene Lebensqualität und soziale Unterstützung von Kindern psychisch kranker Eltern: Effekte einer manualisierten Familienintervention. (Health-related quality of life and social support of children with mentally ill parents: effects of a manualized family intervention). Kindheit und Entwicklung. (2012) 21:64–73. 10.1026/0942-5403/a000071
    1. Wiegand-Grefe S, Cronemeyer B, Halverscheid S, Redlich A, Petermann F. Krankheitsbewältigung psychisch kranker Eltern und psychische Auffälligkeit ihrer Kinder im Fokus einer manualisierten Familienintervention. Zeitschrift für Psychiatrie, Psychologie und Psychotherapie. (2013) 61:51–58. 10.1024/1661-4747/a000140
    1. Wiegand-Grefe S, Alberts J, Petermann F, Plass A. Differential perspectives on family functioning and interfamilial relationships: the effect of a manualized intervention program on children of mentally ill parents. Kindheit und Entwicklung. (2016) 25:77–88. 10.1026/0942-5403/a000192
    1. Waldmann T, Stiawa M, Dinc Ü, Saglam G, Busmann M, Daubman A, et al. Costs of health and social services use in children of mentally ill parents. Results form the CHIMPs trial. Child Adolesc Psychiatry Ment Health. (in review).
    1. Beardslee WR, Wright EJ, Gladstone TRG, Forbes P. Long-term effects from a randomized trial of two public health preventive interventions for parental depression. J Fam Psychol. (2007) 21:703–13. 10.1037/0893-3200.21.4.703
    1. Kaufman J, Birmaher B, Brent DA, Rao U, Ryan N. Kiddie-Sads-Present and Lifetime Version (K-SADS-PL). (1996). Pittsburgh: University of Pittsburgh, School of Medicine; Available online at: (accessed December 23, 2020).
    1. Delmo C, Weiffenbach O, Gabriel M, Stadler C, Poustka F. Diagnostisches Interview Kiddie-Sads-Present and Lifetime Version (K-SADS-PL). 5. Auflage der deutschen Forschungsversion, erweitert um ICD-10-Diagnostik. Frankfurt: Klinik für Psychiatrie und Psychotherapie des Kindes- und Jugendalters; (2001).
    1. Villabø MA, Oerbeck B, Skirbekk B, Hansen BH, Kristensen H. Convergent and divergent validity of K-SADS-PL anxiety and attention deficit hyperactivity disorder diagnoses in a clinical sample of school-aged children. Nordic J Psychiatry. (2016) 70:358–64. 10.3109/08039488.2015.1125944
    1. Arbeitsgruppe Deutsche Child Behavior Checklist . Elternfragebogen über das Verhalten von Kindern und Jugendlichen; deutsche Bearbeitung der Child Behavior Checklist (CBCL/4-18). Einführung und Anleitung zur Handauswertung. 2. Auflage mit deutschen Normen. In: Döpfner M, Plück J, Bölte S, Lenz K, Melchers P, Heim K. editors. Arbeitsgruppe Kinder-, Jugend- und Familiendiagnostik, Köln: (1998).
    1. Arbeitsgruppe Deutsche Child Behavior Checklist Fragebogen für Jugendliche; deutsche Bearbeitung des Youth Self Report (YSR) der Child Behavior Checklist. Einführung und Anleitung zur Handauswertung. 2. Auflage mit deutschen Normen. In: Döpfner M, Plück J, Bölte S, Lenz K, Melchers P, Heim K. Arbeitsgruppe Kinder-, Jugend- und Familiendiagnostik. Köln: (1998).
    1. Van Meter A, Youngstrom E, Youngstrom JK, Ollendick T, Demeter C, Findling LR. Clinical decision making about child and adolescent anxiety disorders using the Achenbach system of empirically based assessment. J Clin Child Adolesc Psychol. (2014) 43:552–65. 10.1080/15374416.2014.883930
    1. The KIDSCREEN Group Europe . The KIDSCREEN Questionnaires. Quality of Life Questionnaires for Children And Adolescents. Handbook. Lengerich: Papst Science Publisher; (2006).
    1. Bouwmans C, Van der Kolk A, Oppe M, Schawo S, Stolk E, van Agthoven M, Hakkaart-van RL. Validity and responsiveness of the EQ-5D and the KIDSCREEN-10 in children with ADHD. J Ment Health Policy Econ. (2013) 16:S3–4. 10.1007/s10198-013-0540-x
    1. Ravens-Sieberer U, Erhart M, Rajmil L, Herdman M, Auquier P, Bruil J, et al. . European: reliability, construct and criterion validity of the KIDSCREEN-10 score: a short measure for children and adolescents' well-being and health-related quality of life. Qual Life Res. (2010) 19:1487–500. 10.1007/s11136-010-9706-5
    1. Steinhausen HC. Eine Skala zur Beurteilung psychisch gestörter Kinder und Jugendlicher. Zeitschrift fuer Kinder- und Jugendpsychiatrie. (1985) 13:230–40.
    1. Shaffer D, Gould MS, Brasic JR, Ambrosini P, Fisher P, Bird HR, et al. . A children's global assessment scale (CGAS). Arch Gen Psychiatry. (1983) 40:1128–31. 10.1001/archpsyc.1983.01790100074010
    1. Franke H. Brief Symptom Inventory von L.R. Derogatis (Kurzform der SCL-90-R). Deutsche Version. Manual. Göttingen: Beltz Test Gesellschaft; (2000).
    1. Löwe B, Spitzer RL, Zipfel S, Herzog W. Gesundheitsfragebogen für Patienten (PHQ-D). Komplettversion und Kurzform. Autorisierte deutsche Version des “Prime MD Patient Health Questionnaire (PHQ)”. Karlsruhe: Pfizer; (2002).
    1. Collegium Internationale Psychiatriae Scalarum Internationale Skalen für Psychiatrie. Göttingen: Beltz Test GmbH; (1996).
    1. Saß H, Wittchen HU, Zaudig M, Houben I. Diganostisches und Statistisches Manual psychischer Störungen—Textrevision. Göttingen: Hogrefe; (2003).
    1. Brooks R, Rabin R, Charro dF. The Measurement and Valuation of Health Status Using EQ-5D. A European perspective. Evidence from the EuroQol BIO MED Research program. New York, NY: Springer; (2003).
    1. Hinz A, Klaiberg A, Brahler E, Konig HH. The quality of life questionnaire EQ-5D: modelling and norm values for the general population. Psychother Psychosom Med Psychol. (2006) 56:42–8. 10.1055/s-2005-867061
    1. Ravens-Sieberer U, Wille N, Badia X, Bonsel G, Burstrom K, Cavrini G, et al. Feasibility, reliability, and validity of the EQ-5D-Y: results from a multinational study. Qual Life Res. (2010) 19:887–97. 10.1007/s11136-010-9649-x
    1. Muthny FA. Freiburger Fragebogen zur Krankheitsverarbeitung. Manual. Weinheim: Beltz Test GmbH; (1989).
    1. Cierpka M, Frevert G. Die Familienbögen. Ein Inventar zur Einschätzung von Familienfunktionen. Göttingen: Hogrefe; (1995).
    1. Dalgard OS, Dowrick C, Lehtinen V, Vazquez-Barquero JL, Casey P, Wilkinson G, et al. . Negative life events, social support and gender difference in depression: a multinational community survey with data from the ODIN study. Soc Psychiatry Psychiatr Epidemiol. (2006) 41:444–51. 10.1007/s00127-006-0051-5
    1. Mattejat F, Remschmidt H. Fragebögen zur Beurteilung der Behandlung (FBB). Handanweisung. Göttingen: Hogrefe; (1999).
    1. Hilsenroth M, Bonge DR, Blagys MD, Ackerman SJ, Blais AM. Measuring psychodynamic-interpersonal and cognitive-behavioral techniques: development of the comparative psychotherapy process scale. Psychother Theory Res Pract Train. (2005) 42:340–56. 10.1037/0033-3204.42.3.340.supp
    1. Beutel ME, Bahrke U, Fiedler G, Hautzinger M, Kallenbach L, Kaufhold J, et al. LAC-Depressionsstudie. Psychoanalytische und kognitiv-verhaltenstherapeutische Langzeittherapien bei chronischer Depression. Psychotherapeut. (2016) 61:468–75. 10.1007/s00278-016-0144-x
    1. Roick C, Kilian R, Matschinger H, Bernert S, Mory C, Angermeyer CM. Die deutsche Version des Client Sociodemographic and Service Receipt Inventory. Psychiat Prax. (2001) 28:84–90. 10.1055/s-2001-17790
    1. Kilian R, Losert C, McDaid D, Park A, Knapp M, Beecham J, et al. The Health Economic Evaluation of Children and Adolescent Mental Health Services Across the Enlarged Europe. Ulm: Ulm University, Department of Psychiatry and Psychotherapy; (2009).
    1. Knapp M. Making music of the noise—the cost function approach to evaluation. Br J Psychiatry. (1998) 173(Suppl. 36):7–11. 10.1192/S0007125000297997
    1. Kilian R, Matschinger H, Becker T, Angermeyer CM. A longitudinal analysis of the impact of social and clinical characteristics on the costs of schizophrenia treatment. Acta Psychiatr Scand. (2003) 107:351–60. 10.1034/j.1600-0447.2003.00072.x
    1. Kilian R, Matschinger H, Löffler W, Roick C, Angermeyer CM. A comparison of methods to handle skew distributed cost variables in the analysis of the resource consumption in schizophrenia treatment. J Ment Health Policy Econ. (2002) 5:21–31.
    1. Manning WG, Mullahy J. Estimating log models: to transform or not to transform? J Health Econ. (2001) 20:461–94. 10.1016/S0167-6296(01)00086-8
    1. Hoch JS, Briggs AH, Willan R. Something odd, something new, something borrowed, something blue: a framework for the marriage of health econometrics and cost-effectiveness analysis. Health Econ. (2002) 11:415–30. 10.1002/hec.678
    1. Willan AR, Briggs HA. Statistical Analysis of Cost-Effectiveness Data. Chichester: Wiley; (2006).
    1. Glick HA. Economic Evaluation in Clinical Trials. Oxford: Oxford Univ. Press; (2010).
    1. Furber G, Segal L. The validity of the child health utility instrument (CHU9D) as a routine outcome measure for use in child and adolescent mental health services. Health Qual Life Outcomes. (2015) 13:22. 10.1186/s12955-015-0218-4
    1. Chen G, Stevens K, Rowen D, Ratcliffe J. From KIDSCREEN-10 to CHU9D: creating a unique mapping algorithm for application in economic evaluation. Health Qual Life Outcomes. (2014) 12:134. 10.1186/s12955-014-0134-z
    1. Kuhn C, Aebi M, Jakobsen H, Banaschewski T, Poustka L, Grimmer Y, et al. . Effective mental health screening in adolescents: should we collect data from youth, parents or both? Child Psychiatry Hum Dev. (2017) 48:385–92. 10.1007/s10578-016-0665-0
    1. Becker A, Hagenberg N, Roessner V, Woerner W, Rothenberger A. Evaluation of the self-reported SDQ in a clinical setting: do self-reports tell us more than ratings by adult informants? Eur Child Adolesc Psychiatry. (2004) 13(Suppl. 2): II1724. 10.1007/s00787-004-2004-4
    1. Dey M, Landolt MA, Mohler-Kuo M. Assessing parent-child agreement in health-related quality of life among three health status groups. Soc Psychiatry Psychiatr Epidemiol. (2013) 48:503–11. 10.1007/s00127-012-0556-z

Source: PubMed

赞助者和合作者

医疗条件

药物干预

3
订阅