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Efficacy and Feasibility of Baby Triple P - a Pilot Study

R

Ruhr University of Bochum

Status

Unknown

Conditions

Mental Disorders During Pregnancy

Treatments

Behavioral: Baby Triple P

Study type

Interventional

Funder types

Other

Identifiers

NCT02313493
RCT-Baby Triple P

Details and patient eligibility

About

In the present pilot study the feasibility and efficacy of Baby Triple P- an antenatal parent training- are investigated. Healthy becoming first time parents were randomly allocated to either the Baby Triple P parent-training group or a care as usual control group. It is expected that 78 couples of becoming first time parents are recruited. It is hypothesized that parents and their infants in the parent training group will show significantly less psychopathology / regulation problems and better partnership quality than participants in the control condition.

Full description

In this pilot study, the efficacy and feasibility of the Baby Triple P parenting training is investigated in a pilot study using a randomized controlled trial. According to the efficacy of the parenting training, it is expected that parents in the training condition show higher scores on mental health scales (BSI-18) and quality of Partnership (PFB). Furthermore, it is expected that infants whose parents has taken part in the parenting training have lower severity ratings of regulatory disorders assessed with the Baby-DIPS diagnostic interview than infants of parents in the care as usual control condition.

Enrollment

78 estimated patients

Sex

All

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Becoming first time parent
  • Participants have a basic level of German literacy which allows them to understand the Baby Triple P materials
  • Unborn Baby is developing well and does not have a pre-diagnosed medical condition

Exclusion criteria

  • Baby has a disability or pre-diagnosed medical condition.
  • The parents are intellectually disabled

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

78 participants in 2 patient groups

Baby Triple P parent training group
Experimental group
Description:
The 8- session program delivered in four group sessions before birth and four telephone sessions after birth is developed for parents at the transition to parenthood or with a baby (up to 12 months of age).
Treatment:
Behavioral: Baby Triple P
Care as usual control group
No Intervention group

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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