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21 March 2013
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| [ Print-friendly version ] |
| Effects of a standardized mother-child intervention programme in adolescent mothers and their children |
| ISRCTN | ISRCTN13962271 |
| DOI | 10.1186/ISRCTN13962271 |
| ClinicalTrials.gov identifier | |
| EudraCT number | |
| Public title | Effects of a standardized mother-child intervention programme in adolescent mothers and their children |
| Scientific title | Behavioural, developmental and neural effects of a standardized mother-child intervention programme in adolescent mothers and their children |
| Acronym | TeeMo |
| Serial number at source | 2.0 (15/08/2012) |
| Study hypothesis | Within a RCT design, a parental programme based on STEEP plus psychiatric treatment of the mother in case of mental illness will be compared to TAU (standardized support by the child welfare office) in adolescent, high-risk mothers. The primary outcome variables are the maternal sensitivity and the child’s well-being. Moderators of treatment outcome (e.g. child development, genotype, child temperament, neural and hormonal mechanism associated with parental bonding in the mother) as well as treatment effects in the child (cognitive and somatic development, structural brain maturation) will be systematically explored. A control goup of adult mothers will be compared with the adolescent group. |
| Lay summary | Lay summary under review 3 |
| Ethics approval | University Hospital of Aachen, 10 September 2012, ref: 12-006 |
| Study design | Randomised controlled trial with three arms |
| Countries of recruitment | Germany |
| Disease/condition/study domain | Adolescent mothers |
| Participants - inclusion criteria |
1. Child 3-6 months of age
2. Mother pregnant before 21st birthday 3. First or second child 4. Verbal intervention possilble (no language or intellectual constraint) 5. Caucasian mother 6. Mother and child live together 7. Informed consent |
| Participants - exclusion criteria |
1. Addiction (except for nicotin)
2. Birth of the child before 35th week of pregnancy was fulfilled 3. Syndromes or severe illnesses within the child 4. Severe psychiatric illness or suicidality within the mother 5. Separation of mother and child more than 3 months 6. Another video-intervention is planned |
| Anticipated start date | 01/10/2012 |
| Anticipated end date | 31/03/2014 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 180 adolescents and 40 adult mother-child-dyads |
| Interventions |
Three arms:
1. Adolescent intervention group 2. Adolescent treatment as usual (TAU) 3. Adult controls The active group will take part in a programme based on the principles of STEEP when the children are at least 3 months of age. They are visited every 2 weeks by the same adviser for the duration of 9 months. The topics of the home visits will be built on the manual by Erickson/Egeland (German edition by Suess, 2009). On average mother-child dyads will receive 12-18 home visits. Every second visit a short video-documentation of mother-child interaction will be analyzed together with the mother, which has proven to be a promising tool to increase sensitive parenting. In addition, psychiatric diseases in the mother (such as depression, etc.) will be treated by a psychiatrist/psychologist if needed. |
| Primary outcome measure(s) |
1. Maternal sensitivity score, assessed by the sensivity-scale of the Emotional Availability Scale (EAS)
2. Child’s" well-being", assessed with the EAS-Scales 3. Child’s responsiveness to the parent 4. Child’s involvement of the parent There will be three appointments: first one at the beginning of the intervention right after the inclusion, next one after intervention (9 months after inclusion) and the last one 6 months after the end of intervention (15 Months after inclusion). TAU and the adult control group will be assessed with parallel appointments. |
| Secondary outcome measure(s) |
1. BIS-15 Barratt Impulsiveness Scale
2. BDI-II Becks Depression Inventory, Second Edition 3. BSDI-III Bayley Scales of Infant Development 4. CAARS Conners Adult ADHD Rating Scale 5. CAPI Child Abuse Potential Inventory (deutsche Version: EBSK) 6. CECA-Q Childhood Experiences of Care Abuse Questionnaire 7. CFT 20-R Culture Fair Intelligence Test – Scale 2, Revision 8. ECR-R Experiences in Close Relationships Scale-Revised 9. DERS Difficulties in Emotion Regulation Scale 10. IBQ-R Infant Behavior Questionnaire 11. IPDE The International Personality Disorder Examination 12. IRI; EC Interpersonal Reacivity Index 13. M.I.N.I .Mini-International Neuropsychiatric Interview 14. PSI Parental Stress Index (deutsche Version: EBI) 15. SST Strange Situation Test (deutsch FST) 16. STAI State-Trait Anxiety Inventory 17. VASQ Vulnerable Attachment Style Questionnaire 18. Analysis of fMRI-paradigms (Baby Face Incentive Delay Task and Infant Cry Self Distraction Paradigma) |
| Sources of funding | Federal Ministry of Education and Research [BMBF] (Germany) ref: 01KR1207B |
| Trial website | http://teemo-aachen.de |
| Publications | |
| Contact name | Prof Beate Herpertz-Dahlmann |
| Address |
University Hospital of the Rheinisch-Westfaelische Technische Hochschule Aachen
Department of Child and Adolescent Psychiatry and Psychotherapy Neuenhofer Weg 21 |
| City/town | Aachen |
| Zip/Postcode | 52074 |
| Country | Germany |
| Tel | +49 241 808 8737 |
| b.herpertzdahlmann@ukaachen.de | |
| Sponsor | Federal Ministry of Education and Research [BMBF] (Germany) |
| Address | Hannoversche Straße 28-30 |
| City/town | Berlin |
| Zip/Postcode | 10115 |
| Country | Germany |
| information@bmbf.bund.de | |
| Sponsor website: | http://www.bmbf.de/en/ |
| Date applied | 19/09/2012 |
| Last edited | 07/01/2013 |
| Date ISRCTN assigned | 07/01/2013 |
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