Improving Mental Health in First Time Parents - A Randomized Controlled Pilot Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Mental Disorders During Pregnancy
- Sponsor
- Ruhr University of Bochum
- Enrollment
- 78
- Primary Endpoint
- Number of symptoms on the BSI 18 and the PFB-K
- Last Updated
- 11 years ago
Overview
Brief 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.
Detailed 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.
Investigators
Lukka Popp
M.Sc.
Ruhr University of Bochum
Eligibility Criteria
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
Outcomes
Primary Outcomes
Number of symptoms on the BSI 18 and the PFB-K
Time Frame: Before birth (T1), two months after birth (T2)
The BSI 18 assessment gathers patient-reported data to help measure psychological distress and psychiatric disorders. The relationship questionnaire (PFB-K) assess partnership satisfaction.
Severity rating (0-8) of regulatory problems in infants
Time Frame: six months after birth (T3)
Regulatory difficulties in crying, sleeping and feeding behavior in infants are assessed with a diagnostic interview (Baby-DIPS). The severity rating ranges from 0-8 (\> 4 indicates a clinical referred disorder).
Secondary Outcomes
- Quality of parenting(Two months after birth (T2), six month after birth (T3))
- Number of symptoms on the EPDS, DASS-21 and the OSS-3(Two months after birth (T2))