Efficacy and Feasibility of Baby Triple P - a Pilot Study
- Conditions
- Mental Disorders During Pregnancy
- Interventions
- Behavioral: Baby Triple P
- Registration Number
- NCT02313493
- Lead Sponsor
- Ruhr University of Bochum
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 78
- 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
- Baby has a disability or pre-diagnosed medical condition.
- The parents are intellectually disabled
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Baby Triple P parent training group Baby Triple P 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).
- Primary Outcome Measures
Name Time Method Number of symptoms on the BSI 18 and the PFB-K 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 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 Outcome Measures
Name Time Method Quality of parenting Two months after birth (T2), six month after birth (T3) Parent-related behavior and cognitions are assessed with the Parenting Sense of Competence Scale (PSOC; T2,T3) with both parents and the Postpartum Bonding Questionnaire (PBQ;T2) only with mothers. Additionally, explorative questionnaires assess program specific parenting skills and educational elements as the number of soothing strategies the parents apply or the knowledge about an infants' development (T2, T3).
Number of symptoms on the EPDS, DASS-21 and the OSS-3 Two months after birth (T2) The Edinburgh Postnatal Depression Scale (EPDS, T2) is a rating scale for measuring the severity of postnatal depression symptoms. The Depression Anxiety Stress Scales (DASS-21) assess symptoms of depressions, anxiety and stress. The Oslo Social Support Scale (OSS-3) measures the subjective amount of social support the parents get.