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Mellow Babies - a Pilot Waiting List Trial

NCT02277301 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2019-04-18

No results posted yet for this study

Summary

This is a mixed-methods study centred on a prospective randomised openlabel blinded endpoint (PROBE) pilot clinical trial with a waitinglist control group. The study will be conducted in three areas of Northern Ireland: Lisburn, North Down \& Ards, and Downpatrick. At least 50 women with infants under 13 months old will be recruited during August/September 2014.

Conditions

  • Mothers Who Have Been Referred for Parenting Support

Interventions

BEHAVIORAL

Mellow Babies

Mellow Babies is an intervention designed for mothers with substantial problems in their relationships with their infants. Typically, participating mothers have mental health difficulties, problem drug use, learning difficulties, forensic issues or they may have children already looked after by the local authority.

Sponsors & Collaborators

  • South Eastern Health and Social Care Trust

    collaborator OTHER

  • University of Aberdeen

    lead OTHER

Principal Investigators

  • Lucy Thompson, BA PhD MPH · University of Aberdeen

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2016-07-31
Completion
2016-07-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02277301 on ClinicalTrials.gov