Family orientated early intervention enhances social-interactive behaviour of premature infants and mother-infant-interaction

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN41063599

Enrollment

108

Registered

2008-02-13

Start date

2002-01-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premature infants Neonatal Diseases Premature infants

Interventions

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 integra

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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. At 6 months corrected age the infant social-interactive behaviour and mother-infant interaction were assessed with the Mother-Infant Structured Play Assessment (MISPA)(Timepoint 2). This is an 8-minute, semi-structured face-to-face play interaction which includes the Still-Face Paradigm, which provides a method to access infant regulatory capacities and illustrates central qualities of the young infant's capacities for interpersonal engagement. For the interaction records the infants were placed on a blanket or mat on the floor and mothers were asked to sit on the floor opposite their infant. A mirror was mounted at an angle, which enabled the examiner to videotape both the face and body of the infant and the face and upper torso of the mother. Standardised instructions were used to explain the procedure to the mothers. Episode 1 involved the mother playing with her baby with a rattle (warm-up). After 2 minutes (Episode 2) she was cued to lay aside the rattle and play (without a toy) with her baby for another 2 minutes. Then she was asked to get her baby to watch her face, which lasted for 1 minute (Episode 3). Next she was asked to make a still-face for 1.5 minutes (Episode 4) and then finally asked to resume playing with her baby for another 1.5 minutes (Episode 5). Three existing schemes were modified and adapted to create a suitable coding scheme: 1. The Play Observation Scheme and Emotion Ratings (POSER) 2. The Emotional Availability	—

Measure

Time frame

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. At 6 months corrected age the infant social-interactive behaviour and mother-infant interaction were assessed with the Mother-Infant Structured Play Assessment (MISPA)(Timepoint 2). This is an 8-minute, semi-structured face-to-face play interaction which includes the Still-Face Paradigm, which provides a method to access infant regulatory capacities and illustrates central qualities of the young infant's capacities for interpersonal engagement. For the interaction records the infants were placed on a blanket or mat on the floor and mothers were asked to sit on the floor opposite their infant. A mirror was mounted at an angle, which enabled the examiner to videotape both the face and body of the infant and the face and upper torso of the mother. Standardised instructions were used to explain the procedure to the mothers. Episode 1 involved the mother playing with her baby with a rattle (warm-up). After 2 minutes (Episode 2) she was cued to lay aside the rattle and play (without a toy) with her baby for another 2 minutes. Then she was asked to get her baby to watch her face, which lasted for 1 minute (Episode 3). Next she was asked to make a still-face for 1.5 minutes (Episode 4) and then finally asked to resume playing with her baby for another 1.5 minutes (Episode 5). Three existing schemes were modified and adapted to create a suitable coding scheme: 1. The Play Observation Scheme and Emotion Ratings (POSER) 2. The Emotional Availability

—

Secondary

Measure	Time frame
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.	—

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026