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Preterm Infant Parent Programme for Attachment (PIPPA study)

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN92360616
Enrollment
90
Registered
2012-05-31
Start date
2012-05-14
Completion date
Unknown
Last updated
2018-04-30

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

Conditions

Preterm birth, attachment, social-emotional development, parental mental health Pregnancy and Childbirth Disorders related to short gestation and low birth weight, not elsewhere classified

Interventions

Current interventions as of 15/03/2018: Infants and their parents are randomly allocated to receive the PIPPA programme or to receive routine support from medical, nursing and social work staff. Int

Sponsors

National Children's Research Centre (Ireland)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Infants born at less than 32 weeks gestation

Exclusion criteria

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)

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Ireland

Outcome results

None listed

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