Overview

This trial is active, not recruiting.

Condition mental disorders during pregnancy
Treatment baby triple p
Sponsor Ruhr University of Bochum
Start date September 2012
End date July 2015
Trial size 78 participants
Trial identifier NCT02313493, RCT-Baby Triple P

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model single group assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
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).
baby triple p
(No Intervention)

Primary Outcomes

Measure
Number of symptoms on the BSI 18 and the PFB-K
time frame: Before birth (T1), two months after birth (T2)
Severity rating (0-8) of regulatory problems in infants
time frame: six months after birth (T3)

Secondary Outcomes

Measure
Quality of parenting
time frame: Two months after birth (T2), six month after birth (T3)
Number of symptoms on the EPDS, DASS-21 and the OSS-3
time frame: Two months after birth (T2)

Eligibility Criteria

Male or female participants of any age.

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

Additional Information

Official title Improving Mental Health in First Time Parents - A Randomized Controlled Pilot Study
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2014.
Information provided to ClinicalTrials.gov by Ruhr University of Bochum.