|- candidate number||8548|
|- NTR Number||NTR2569|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||12-okt-2010|
|- Secondary IDs||80-82435-98-9125 ZonMw|
|- Public Title||Effects of preventive case management on parenting and children of mental patients.|
|- Scientific Title||Effecten van preventieve zorgco÷rdinatie op problematische opvoedingssituaties bij ouders met psychiatrische problemen.|
|- hypothesis||Parens with psychiatric problems often have parenting problems, in particular when they have to deal with other risk factors for poor parenting like for instance isolation and poverty. This means an enhanced risk for their children on developing behavioral problems. Co÷rdinated early help for these high risk families as offered by the program Preventive Basic Care Management (PBCM), could prevent severe parenting problems and thereby reduce the risk of behavioural problems in the children. |
|- Healt Condition(s) or Problem(s) studied||Mental illness, Depression, Prevention, COPMI|
|- Inclusion criteria||1. Psychiatric patients with children between 3 and 9 years (not suffering from a childhood mental disorder or mental retardation);|
2. Parenting problems;
3. More than three risk factors which threaten good parenting.
|- Exclusion criteria||1. No psychiatric treatment or finish of treatment within three months;|
2. Therapist is reffering child to social services.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-sep-2010|
|- planned closingdate||1-jun-2013|
|- Target number of participants||116|
|- Interventions||The PBCM intervention includes:|
1. Systematic assessment;
2. Intervention planning and coordinating supportive services, tailored to address the identified risk factors of poor parenting;
3. Monitoring and evaluating the implementation of the indicated supportive services and their effects.
The assessment is standardised and focused on (1) identifying early signs of behavioural problems in children, (2) description and evaluation of parenting behaviour, and (3) taxation of risk and protective factors for parenting, including parental competences. Risk assessment is done in home visits, interviews with parents and involved services, such as schools, child care centres, youth health services and therapists. The assessment is used to identify needs for preventive support in parents and children. Parents are explicitly asked about the goals they want to achieve through their involvement in the PBCM programme. These goals are central targets for the next step.
Intervention planning and coordination:
This assessment is used to design a tailored intervention plan for the family. The plan is developed in several steps. First, the assessment is discussed in the PBCM team to design a draft intervention plan. Then, the assessment and this intervention proposal are discussed with (preferably both) parents and involved services in a joint meeting.
First priorities in the PBMC process often adress parenting problems with structuring daily family life and parental dissatisfaction with psychiatric treatment or stagnations. Families are referred to Family Services for help with improving daily structure and organisation of family life. The PBCM manager discusses how treatment stagnations can be solved with the therapist and the parent. Secondly, interventions for tackling contextual risk factors and improving contextual protective factors such as co-parent arrangement, social support, family living conditions, utilization of Child Care, poverty are planned.
The final plan is family tailored, assessment-based and consists of multiple interventions. Actions are formulated in terms of parenting behaviours and actions of services. The PBCM manager sets criteria for the goal and the implementation of services in order to adjust them to the needs and risks of the family. Timing and dosage are optimally adjusted to the capacities of the parents. He/she advises parents, facilitates the use of specialised services and advocate their interest. Finally, he/she gives an overview of the agreed actions, and documents concrete settlements. Clear goals and settlements are written down and sent to all participants.
Monitoring and evaluation:
Follow up co-ordination meetings with parents and services are planned bi-monthly and constitute a core element in the Case Management strategy. In these bi-monthly meetings the PBCM manager discusses the progress and the settlements made in de previous meeting in a systematic way.
The programme ends when a sufficient level of positive parenting behaviour is accomplished and the targeted reduction of risk factors is secured. The maximum duration of the programme is eighteen months. As a rule families have about eight meetings during this period.
The control condition includes a flyer about effects of psychiatric problems of parents in children and the possibility for personal advice and supportgroups for children and/or parents of the COPMI-programme. COPMI stands for Children of Parents with a Mental Illness. Parents are free to participate in these and other preventive services on their own initiative, but therapists will not actively or systematically stimulate the use of services.
|- Primary outcome||Parenting, measured by the HOME Inventory (http://ualr.edu/case/index.php/home/home-inventory/, retrieved 26-102010) and by the Parenting Daily Hassles (Crinic & Greenberg, 1990).
|- Secondary outcome||1. Social and emotional development in the child, measured by the Strenght and Difficulty Questionnaire parents and teacher-version (http://www.sdqinfo.com/b1.html, retrieved 26-1-12010);|
2. Consumed preventive care and consumed indicated care, measured by a structured interview on support, health care, child psychiatric services and family services in the last three months. A questionnaire was developed for this purpose, called the Questionnaire Support and Help.
|- Timepoints||Baseline, 9 months, 18 months:|
1. HOME, Parenting Daily Hassles;
3. Questionnaire Support and Help.
|- Trial web site||www.SOOPP.nl|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Drs. Henny Wansink|
|- CONTACT for SCIENTIFIC QUERIES||Drs. Henny Wansink|
|- Sponsor/Initiator ||Fonds NutsOhra, ZonMw: The Netherlands Organization for Health Research and Development, BavoEuropoort - ParnassiaBavogroep|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development, Fonds Nuts-Ohra, BavoEuropoort - ParnassiaBavogroep|
|- Brief summary||Effects of preventive casemanagement on parenting of mental patients and behavioral problems in children is studied in a RCT with 116 families. Consumption of preventive and indicated care is used for a CEA.
|- Main changes (audit trail)|
|- RECORD||12-okt-2010 - 30-okt-2010|