Condition category
Mental and Behavioural Disorders
Date applied
19/09/2012
Date assigned
07/01/2013
Last edited
07/09/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
In Germany about 7,500 babies are born each year to mothers below the age of 18, and 22,000 to mothers below age 20. Teenage pregnancy in Germany is more common among individuals with lower socio-economic status and poor education. Childhood neglect, physical and sexual abuse, inconsistent parenting and being a child to a teenage mother themselves are all risk factors for pregnancy in adolescence. Thus, children of adolescent mothers are a high-risk group for child neglect and maltreatment, especially if other sources of stress are present. Their development is often disturbed and they display more aggressive behaviour than children of adult mothers. Based on the results of a previous study, a training programme for young mothers was developed (STEEP, Steps Toward Effective and Enjoyable Parenting). However, so far nothing is known about whether a child´s well-being can be increased by such a training programme. We want to find out whether STEEP helps to develop maternal sensitivity and how this effects attachment and child well-being.

Who can participate?
120 mothers who were pregnant before their 21st birthday (adolescent mothers) and their children aged 3-6 months, and 40 mothers aged 25 or over (adult mothers).

What does the study involve?
The adolescent mothers are randomly allocated to one of two groups. The intervention group will take part in a programme based on the principles of STEEP. The mothers are visited every 2 weeks by the same adviser until the child is 12 months old. Every second visit a short video of the mother and child interacting will be analyzed together with the mother, which has proven to be a promising way to increase sensitive parenting. In addition, psychiatric diseases in the mother (such as depression) will be treated by a psychiatrist/psychologist if needed. The other group will receive treatment as usual (support from the child welfare office). For further comparisons 40 mothers aged 25 or over (adult mothers) and matched for education will also be assessed. The study involves three assessment points: one at the beginning of the study, one after 9 months of treatment and a third one after another 6 months. Participants are interviewed, complete questionnaires, and are asked to leave saliva, hair and blood samples and to undergo an MRI scan.

What are the possible benefits and risks of participating?
The STEEP intervention may improve the relationship between the mother and the child. There are no risks of participating.

Where is the study run from?
University Hospital of the Rheinisch-Westfaelische Technische Hochschule Aachen (Germany).

When is the study starting and how long is it expected to run for?
October 2012 to June 2016.

Who is funding the study?
Federal Ministry of Education and Research (Germany).

Who is the main contact?
Prof Beate Herpertz-Dahlmann
b.herpertzdahlmann@ukaachen.de

Trial website

http://teemo-aachen.de

Contact information

Type

Scientific

Primary contact

Prof Beate Herpertz-Dahlmann

ORCID ID

http://orcid.org/0000-0001-8450-3323

Contact details

University Hospital of the Rheinisch-Westfaelische Technische Hochschule Aachen
Department of Child and Adolescent Psychiatry and Psychotherapy
Neuenhofer Weg 21
Aachen
52074
Germany
+49 (0)241 808 8737
b.herpertzdahlmann@ukaachen.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

7.0

Study information

Scientific title

Behavioural, developmental and neural effects of a standardized mother-child intervention programme in adolescent mothers and their children

Acronym

TeeMo

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.

On 04/09/2015 the overall trial end date was changed from 31/03/2014 to 30/06/2016.

Ethics approval

University Hospital of Aachen, 10/09/2012, ref: 12-006

Study design

Randomised controlled trial with three arms

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Adolescent mothers

Intervention

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.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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 measures

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)

Overall trial start date

01/10/2012

Overall trial end date

30/06/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Child 3-6 months of age
2. Mother pregnant before 21st birthday
3. First or second child
4. Verbal intervention possible (no language or intellectual constraint)
5. Caucasian mother
6. Mother and child live together
7. Informed consent

Participant type

Other

Age group

Mixed

Gender

Both

Target number of participants

180 adolescents and 40 adult mother-child-dyads

Participant exclusion criteria

1. Addiction (except for nicotine)
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

Recruitment start date

01/10/2012

Recruitment end date

01/11/2015

Locations

Countries of recruitment

Germany

Trial participating centre

University Hospital of the Rheinisch-Westfaelische Technische Hochschule Aachen
Aachen
52074
Germany

Sponsor information

Organisation

Federal Ministry of Education and Research [BMBF] (Germany)

Sponsor details

Hannoversche Straße 28-30
Berlin
10115
Germany
-
information@bmbf.bund.de

Sponsor type

Government

Website

http://www.bmbf.de/en/

Funders

Funder type

Government

Funder name

Bundesministerium für Bildung und Forschung

Alternative name(s)

Federal Ministry of Education and Research, BMBF

Funding Body Type

government organisation

Funding Body Subtype

federal

Location

Germany

Results and Publications

Publication and dissemination plan

To be confirmed at a later date

Intention to publish date

Participant level data

Stored in repository

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes