|- candidate number||8710|
|- NTR Number||NTR2624|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||26-nov-2010|
|- Secondary IDs||2010/203 METC UMCG|
|- Public Title||The effectiveness of the Stepping Stones Triple P program to support parents of children with mild ID.|
|- Scientific Title||The effectiveness of the Stepping Stones Triple P program to support parents of children with mild ID.|
|- Healt Condition(s) or Problem(s) studied||Parenting problems, Behavioral problems, Psychosiocial problems|
|- Inclusion criteria||Inclusion criteria for questionnaire study (part 1 of the study) are: |
1. Age 5 to 12 years;
2. Mild intellectual disability (IQ 50-85).
Inclusion criteria for the intervention study (part 2 of the study) are:
1. Strengths and Difficulties Questionnaire (SDQ) clinical total problem score (>14).
|- Exclusion criteria||Exclusion criteria for the questionnaire study are:|
1. No parenting situation (i.e. children live in residential care);
2. Parents are unable to speak Dutch;
3. IQ of the child is unknown;
4. Parents do not live within the research area.
Exclusion criteria for the intervention study are:
1. Brother or sister with higher SDQ score participating in the study;
2. Parent receive treatment for parenting skills or other treatment which potentially conflict with SSTP.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-okt-2010|
|- planned closingdate||1-dec-2013|
|- Target number of participants||210|
|- Interventions||Stepping Stones Triple P (SSTP) involves 8-10 individual sessions, which typically last 60 -120 minutes each. SSTP forms part of the Triple P system and is adapted for families with children who have a disability. In-session behavioral rehearsal and dedicated practice sessions provide opportunities for parents to practice and review their use of positive parenting skills. The effects of the intervention will be studied in a randomized controlled trial. Parents are randomized to the intervention or a control group. The control group receives care as usual.|
|- Primary outcome||The primary outcome is the change in child problem behavior after intervention.|
The following instruments will be applied:
1. Strengths and Difficulties Questionnaire (SDQ);
2. Eyberg Child Behaviour Inventory (ECBI).
|- Secondary outcome||The secondary outcome measures comprise parenting skills (perceived stress due to parenting and parenting practices).|
The following instruments will be applied:
1. Dutch Parental Stress Index (PSI);
2. Alabama Parenting Questionnaire (APQ).
|- Timepoints||Outcome measures will be assessed (by means of questionnaires) at inclusion, and immediately after the intervention (after 3 months). For the evaluation of long-term effects, the study protocol provides an additional follow-up 6 months after the intervention. |
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| M. Kleefman|
|- CONTACT for SCIENTIFIC QUERIES||Prof. MD, PhD, S.A. Reijneveld|
|- Sponsor/Initiator ||University Medical Center Groningen (UMCG), Department of Health Sciences|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||A recent Dutch study showed that 61% of children with mild intellectual disability (ID) had problems with behavior, emotions and relationships, compared to 9.8% of children without ID. Parents raising a child with a diagnosis of both ID and psychosocial problems experience more stress, especially in domains related to child rearing. Stepping Stones Triple P (SSTP) appears promising for families that encounters psychosocial problems in their child with ID but its effectiveness in a Dutch setting has to be shown yet.
The effects of SSTP will be studied in a randomised controlled trial (RCT). SSTP is a variation of Triple P for families with children who have a disability. Parents of children 5-12 year and IQ 50-85 will be selected at schools, the questionnaire study. Parents of children with increased levels of psychosocial problems (SDQ>14) are assigned at random to the experimental group (SSTP) or to a control group (CAU) by the UMCG, the intervention study. The intervention study will include 2*105=210 children (5-12 years). Outcome measures behavior of the child and parenting skills will be assessed at 3 moments: before, at the end of the intervention and 6 months later. |
|- Main changes (audit trail)|
|- RECORD||26-nov-2010 - 11-dec-2010|