Condition category
Pregnancy and Childbirth
Date applied
01/05/2012
Date assigned
31/05/2012
Last edited
31/05/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
We know that the relationship a baby makes with his parents is important for their future development. Babies make a special relationship called an attachment relationship to their mother and father. Feeling safe and emotionally secure has an important impact on babies’ development. We also know from previous research that this relationship is especially important for premature and sick babies.
Preterm birth is one of the most important public health concerns. The relationship between the infant and his or her parents is vital to the infant’s development, but parents may suffer anxiety, depression and post-traumatic stress following the birth. Infants may have medical problems and may need to stay in hospital for a long period of time. Parents and infants may need extra support during this time in beginning their relationship.
As part of the work of the neonatal unit, caring for preterm babies, the study team would like to learn more about how preterm babies who require admission to the neonatal intensive care unit (NICU) develop their attachment relationship with their parents and to see how babies and their parents can be supported during this time.
So that we can do this, the study team will conduct a 3 session programme which aims to support the developing relationship between the baby and his or her parents.
The aims of the study are:
To investigate whether a preterm infant-parent relationship-based programme ( PIPPA) will improve the developing attachment relationship and social-emotional outcomes of preterm infants < 32 weeks gestation compared with routine care.
To investigate whether the PIPPA programme will improve parental outcomes in terms of anxiety, depression, post-traumatic stress and parenting stress.
The study’s findings will help to understand and improve the supports for the developing attachment between parents and their preterm infants.

Who can participate?
Babies who are born at or less than 32 weeks in the National Maternity Hospital, Dublin and their parents, who are from the area which the hospital serves can take part.

What does the study involve?
Infants and their parents are randomly allocated to receive the PIPPA programme or to receive routine support from medical, nursing and social work staff.
All parents who consent to take part in the study will be asked to complete a set of questionnaires at the beginning of the study and before your baby goes home. These questionnaires will ask about your mood, anxiety, stress and feelings as a parent. These questionnaires will take about half an hour to complete.
All babies and their parents who take part in the study will be asked to attend for a follow-up appointment when your baby is 6 – 9 months old. There will be three parts to this appointment, which will take about one hour.
As part of the study the mother and baby will be video-recorded playing together for about 5 minutes. This film can help us to see the ways babies and mothers play and communicate. The video, which will have no identifying details on it, will be looked at and coded by a specially trained person.
Your baby will have a routine clinical examination by the paediatrician.
Both mother and father will also be asked to complete questionnaires about your mood, anxiety, stress and you’re experience as a parent, your baby’s social and emotional development.

What are the possible benefits and risks of participating?
We hope that taking part in the PIPPA study will help the infants and their parents getting started in their relationships and enjoyment of these relationships. The programme may help some parents with anxiety. Information obtained during the course of the study may help us to understand better how a premature baby forms their attachment relationship with their parents, to understand their social and emotional development better and what supports will help preterm babies and their parents in the future. We hope that taking part in the study will improve the care of babies and parents now and in the future.
Parents may find the interview about their child's birth and development an emotional experience. Parents may feel a range of emotions such as sadness, anger or anxiety as they talk about their experiences. These feelings are natural and it can be helpful to talk them through. There are no physical risks to taking part in this study for you or your baby.

Where is the study run from?
The study is being run from the National Maternity Hospital, Dublin, Ireland with support from the National Children’s Research Centre, Dublin.

When is study starting and how long is it expected to run for?
The study will begin enrolling parents and infants in May 2012 and will continue for approximately 2 years. The study will be recruiting patients for approximately 18 months.

Who is funding the study?
The National Children’s Research Centre, Dublin, Ireland is funding the study

Who is the main contact?
Dr. Aoife Twohig
atwohig@nmh.ie, aoife.twohig@gmail.com

Trial website

Contact information

Type

Scientific

Primary contact

Prof Eleanor Molloy

ORCID ID

Contact details

Department of Paediatrics
National Maternity Hospital
Holles Street
Dublin
2
Ireland
+353 (0)1 6373438
elesean@hotmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

D/11/6

Study information

Scientific title

Preterm Infant Parent Programme for Attachment (PIPPA study): a randomised controlled trial of the preterm infant-parent relationship-focused intervention programme to support attachment and social-emotional development of preterm infants

Acronym

PIPPA

Study hypothesis

The hypothesis is that infants and parents receiving the PIPPA programme will have increased sensitivity and synchrony in interaction (developing attachment) and improved social emotional outcomes compared to the infants and parents receiving routine support.

Null Hypothesis: is that there will be no difference between the treatment groups.

Ethics approval

Ethics Committee of the National Maternity Hospital, Dublin, 27 March 2012

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Patient information sheet can be found at https://www.dropbox.com/s/prw1p4nnfryx6ww/Pippa_Info_Leaflet_Draft04.pdf

Condition

Preterm birth, attachment, social-emotional development, parental mental health

Intervention

Infants and their parents are randomly allocated to receive the PIPPA programme or to receive routine support from medical, nursing and social work staff.

Intervention Group: Preterm Infant-Parent Programme for Attachment (PIPPA)
This programme has been developed for this study drawing on previously described early intervention programmes for preterm infants, manualised psychotherapy interventions and psychodynamically informed infant observation. The intervention has been developed following review of the literature supporting the components of the intervention.
The intervention components aim to facilitate the development of the infant-parent relationship through:
1. Working with the parents to reduce anxiety and post-traumatic stress
2. Supporting the parents' formation of realistic representations of their baby
3. Helping parents to identify infant communications and supporting appropriate responses to these, thus enhancing parental sensitivity.
The program will be offered over 3 sessions during the infant’s admission

Detailed intervention for PIPPA study

Session 1:
Clinical Interview with the parents: 45 minutes
Outline – The clinical interview with the parents aims to engage the parents in the programme and establish the relationship with the MD student/ therapist. The interview will begin with a history of the pregnancy and birth of their infant. The MD student will then discuss with the parents their emotional reactions to the pregnancy and the preterm birth and their first experiences with their baby. The interview is based on the routine psychiatric interview and a standardised interview which assesses parent’s representations of their child, the Working Model of the Child Interview. This will be adapted to the situation of preterm birth. The final part of the interview will outline the structure of the following infant observation session.

Session 2:
First Infant Observation: 30 minutes
Observing babies can bring an awareness of the baby’s experiences to parents and also caregivers. The presence of the baby in the session has been shown to facilitate parental sensitivity and engagement. The observation will be arranged at a time when the parent/s are visiting their baby.

The session will comprise of 3 parts:
1. Meeting the parents at the incubator / cot, brief review of their baby’s progress and their own progress since first meeting.
2. Observing the baby’s appearance, state of arousal, quality of movements, responses to stimuli from the environment or to internal processes and their expressions / signs of stress, defensive / shut down mechanisms, self-regulation capacities.
3. Supporting parents spontaneous and sensitive interactions with their baby –parent’s actions, behaviours, thoughts, and expressions in relation to their baby will be facilitated through the positive alliance of the MD student / therapist with the parents.
4. Brief interview with parents – 15 minutes
This follow up meeting will review parent’s reflections on the infant observation session, their own observations of their infant. Parents will be encouraged to express their fears, anxieties and other emotional experiences. These feelings will be listened to empathically and parents helped to identify ways of coping with such feelings. Emerging representations of their infant and their relationship will be highlighted.

Session 3
This session will be conducted in two parts, with a break between.
2nd Infant Observation – 30 minutes - 15 minutes video taped.
The second observation will be conducted in the same manner as the first; however half of the session will be videotaped. When possible this session will take place when the infant can be nested in skin to skin contact, held by the parents or after a feed. This will allow observation of the infant in a situation of optimal interaction with the parent. The focus of the observation will be on noting the infant’s forms of communication and early developing social-emotional capacities.

Interview with parents – feedback on video clips – 30 minutes
This is the final session before discharge. The session aims to review previous sessions with parents and jointly review the video clip of the infant observation. The feedback will involve illustrating positive interactions between infant and parents. Parents will be asked to complete questionnaires on anxiety, depression and post-traumatic stress.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Attachment will be measured using an assessment of infant – mother interaction, a precursor of later attachment at 6 months corrected gestational age.

Infant Assessment of Attachment- Care Index
The CARE-Index (Crittenden, 2004) assesses mother-infant interaction from birth to about two years of age based on a short, videotaped play interaction of 3-5 minutes. Coding of an interaction takes about 15-20 minutes. The measure assesses mothers on three scales: sensitivity, covert and overt hostility, and unresponsiveness. There are also four scales for infants: cooperativeness, compulsive compliance, difficultness, and passivity. These scales tend to be related to the maternal scales in the order listed. The scales are highly correlated with the infant Strange Situation assessment patterns of attachment, differentiate clinically at risk and adequate mother-infant dyads, can be used during intervention and can be used to assess the effectiveness of intervention.
The information derived from the CARE-Index can be used as quasi-continuous or categorical data. The CARE-Index will be video-taped and coded by blinded independent certified coders. The video material will be kept in a secure filing cabinet in a secure office. The tapes will be destroyed on completion of the study.

Secondary outcome measures

1. Ages and Stages Questionnaire – Social-Emotional Development version
This is a questionnaire assessing several domains of infant social, emotional and regulatory development.
2. Parent questionnaires (State Trait Anxiety Inventory, Perinatal Post-traumatic Questionnaire, and Beck Depression Inventory) will be repeated at the 6 month follow up assessment. The Parenting Stress Index will also be administered at this time point.
3. Bayley's score at 2 years: A standardized assessment of infant development (Griffiths or Bayley scales of development) and the routine paediatric assessment will be performed at 6 months.
4. Neonatal Biomarkers, MRI - Brain at 2 years

Overall trial start date

14/05/2012

Overall trial end date

31/03/2014

Reason abandoned

Eligibility

Participant inclusion criteria

Infants born at less than 32 weeks gestation

Participant type

Patient

Age group

Neonate

Gender

Both

Target number of participants

90

Participant exclusion criteria

1. Known major congenital anomaly incompatible with life
2. Parents' level of English will make completion of the semi-structured interview difficult
3. Family does not live within the catchment area of National Maternity Hospital (NMH)

Recruitment start date

14/05/2012

Recruitment end date

31/03/2014

Locations

Countries of recruitment

Ireland

Trial participating centre

Department of Paediatrics
Dublin
2
Ireland

Sponsor information

Organisation

National Children's Research Centre (Ireland)

Sponsor details

Our Lady's Children's Hospital
Crumlin
Dublin
12
Ireland
+353 (0)1 4096419
info@nationalchildrensresearchcentre.ie

Sponsor type

Hospital/treatment centre

Website

http://www.childrensresearchcentre.org/

Funders

Funder type

Hospital/treatment centre

Funder name

National Childrens Research Centre (Ireland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes