Family orientated early intervention enhances social-interactive behaviour of premature infants and mother-infant-interaction
| ISRCTN | ISRCTN41063599 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN41063599 |
| Protocol serial number | N/A |
| Sponsor | Beta Institute for Research and Development in Social Medicine (Germany) |
| Funders | The study was internally founded by the beta Institute for Research and Development in Social Medicine (beta Institut für Sozialmedizinische Forschung und Entwicklung), Augsburg, Germany., The study was also supported by the following institutions:, Köhler foundation (Köhler Stiftung), Essen, Germany (S112/10020/02), Northrine-Westphalia Welfarework Foundation (Stiftung Wohlfahrtspflege Nordrhein-Westfalen), Düsseldorf, Germany (SW-620-4206-Z) |
- Submission date
- 23/10/2007
- Registration date
- 13/02/2008
- Last edited
- 13/02/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Neonatal Diseases
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
Stenglinstr. 2
Augsburg
D 86156
Germany
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomized, single-blind, single-center trial. |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | PRIMA Study (Prospective Randomized Implementation of the Model-project Augsburg) |
| Study objectives | Condition: Very preterm children who are at an increased risk of cognitive impairments, poor educational achievement and behavior problems and psychopathology. Most consistently, an increased risk for attention problems, hyperactivity and social or peer relationship problems have been reported across a range of hospital and geographically defined cohorts. Improvements in infant self-regulation and mother-infant-relationship may avert longterm behavioural and social relationship sequelae of very preterm birth. A first step in demonstrating such a link is to test in a randomised controlled trial whether an individualised family based approach can alter infant social-emotional regulation. Hypothesis: Does an individualised family-based early support intervention (case management approach) for mothers of prematurely born infants alter 1) the maternal sensitivity and 2) infant social-emotional regulation and reciprocal quality of mother-infant interaction in the first 6 months of life? |
| Ethics approval(s) | Ethics board of Rheinische Friedrich Wilhelms University, Bonn, Germany. Approved on 27/11/2001 (ref: 181/01) |
| Health condition(s) or problem(s) studied | Premature infants |
| Intervention | 43 families with 55 children were randomized in the intervention group and 44 families with 53 children in the control group. The aim of our individualised, family-based intervention was to integrate parents in the care of their babies from the very beginning in the NICU and to support families with social needs by providing parent education, improving care-giving competence, enhancing parent-infant interaction, evaluation of the needs and resources of the family, psychosocial care and emotional support, and establishing a network for the family. Beginning in the first week of life trained nurses, social workers and psychologists as required visited as case managers the mothers in the NICU and at home after discharge of the baby up to six months. The intervention addressed problems in four domains including 1) caregiving environment, 2) infant behaviour and characteristics, 3) home discharge and community resources, and 4) family organisation and functioning. Visiting was every two to three days during hospital stay and 1-2 weekly after discharge as needed by the family. The mean duration of the intervention was 161.9 days (45-277): 35.2 days (1-108) during hospital stay and 126.7 days (14-210) after discharge. The professions involved were: nurses in all families, social workers in 42.6% and psychologists in 4.8%. |
| Intervention type | Other |
| Primary outcome measure(s) |
The primary outcome measure was the improvement in social-interactive behaviour of the infants, mother's sensitivity and the dyadic quality of interaction. Before discharge the nurses assessed the early mother sensitivity with the Boston City Hospital Assessment of Parental Sensitivity (BCHAPS)(Timepoint 1). This questionnaire consists of 13 closed-ended items, evaluating the mother's sensitive responsivness and care giving competence. The items are ranked on 5-point scales from "poor" to "competent" and the scores totalled. |
| Key secondary outcome measure(s) |
The demographic characters and the medical and psychosocial burden of the families were recorded with a structured mother-interview at both time points. Several items of the interview ware totalled showing a dyadic adjustment scale and a psyochosocial stress-index. |
| Completion date | 31/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | All |
| Target sample size at registration | 108 |
| Key inclusion criteria | Families with premature births <32 weeks Gestational Age (GA) or birth weight below 1500 g and cared for in the Neonatal Intensive Care Unit (NICU) of the University Children Hospital, Bonn, Germany, between 1 January 2002 and 31 December 2003. |
| Key exclusion criteria | 1. Families living more than 100 km from the hospital 2. Mother did not speak German 3. Infant was transferred to another hospital 4. Infant died or suffered major malformations |
| Date of first enrolment | 01/01/2002 |
| Date of final enrolment | 31/12/2005 |
Locations
Countries of recruitment
- Germany
Study participating centre
D 86156
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |