Efficacy and Feasibility of Baby Triple P - a Pilot Study

Improving Mental Health in First Time Parents - A Randomized Controlled Pilot Study

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.

Study Overview

• Status: Unknown
• Conditions: Mental Disorders During Pregnancy
• Intervention / Treatment: Behavioral: Baby Triple P

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.

• Study Type: Interventional
• Enrollment (Anticipated): 78
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Baby Triple P parent training group; 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).	Behavioral: Baby Triple P
No Intervention: Care as usual control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of symptoms on the BSI 18 and the PFB-K	The BSI 18 assessment gathers patient-reported data to help measure psychological distress and psychiatric disorders. The relationship questionnaire (PFB-K) assess partnership satisfaction.	Before birth (T1), two months after birth (T2)
Severity rating (0-8) of regulatory problems in infants	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).	six months after birth (T3)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of parenting	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).	Two months after birth (T2), six month after birth (T3)
Number of symptoms on the EPDS, DASS-21 and the OSS-3	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.	Two months after birth (T2)

Collaborators and Investigators

• Sponsor: Ruhr University of Bochum

Publications and helpful links

General Publications

• Popp L, Fuths S, Schneider S. The Relevance of Infant Outcome Measures: A Pilot-RCT Comparing Baby Triple P Positive Parenting Program With Care as Usual. Front Psychol. 2019 Oct 29;10:2425. doi: 10.3389/fpsyg.2019.02425. eCollection 2019.
• Popp L, Schneider S. Attention placebo control in randomized controlled trials of psychosocial interventions: theory and practice. Trials. 2015 Apr 11;16:150. doi: 10.1186/s13063-015-0679-0.

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Anticipated): July 1, 2015
• Study Completion (Anticipated): November 1, 2015

Study Registration Dates

• First Submitted: December 7, 2014
• First Submitted That Met QC Criteria: December 7, 2014
• First Posted (Estimate): December 10, 2014

Study Record Updates

• Last Update Posted (Estimate): December 11, 2014
• Last Update Submitted That Met QC Criteria: December 9, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders
• Other Study ID Numbers: RCT-Baby Triple P