Condition category
Not Applicable
Date applied
15/08/2019
Date assigned
29/08/2019
Last edited
29/08/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The transition to parenthood is a critical phase for couples and often relational well-being (i.e., relationship satisfaction) deteriorates. As parents’ relationship well-being is a significant predictor of children’s well-being, this decrease is also critical for children. Thus, strengthening couples during the transition to parenthood seems particularly important. Different intervention programmes targeting the transition to parenthood reported positive effects on relationship satisfaction, communication and child adjustment.

Who can participate?
Participants are couples in the transition to parenthood, thus who are expecting their first child.

What does the study involve?
The trial contains two couple-focused interventions, targeting the enhancement of partners’ relational skills (communication, dyadic coping, problem-solving, self-regulation in relationships) with the aim to improve relational well-being, partners’ well-being, coparenting and, consequently, foster healthy child development. We randomly assigned mixed-sex couples to a high or low dose intervention or a waiting list control condition. The high dose intervention consists of a training of relational skills, whereas in the low dose condition participants receive a psychoeducational movie.

What are the possible benefits and risks of participating?
Benefits of participation are the training, there are no anticipated risks.

Where is the study run from?
The study is run from Switzerland and takes place at couples' homes.

When is the study starting and how long is it expected to run for?
The study started in June 2014 and will continue until June 2020.

Who is funding the study?
The study is funded by the Swiss National Science Foundation (SNSF: grant numbers: 146775 and 173270, desk@snf.ch).

Who is the main contact?
Guy Bodenmann, University of Zurich.

Trial website

Contact information

Type

Scientific

Primary contact

Ms Celine Stadelmann

ORCID ID

http://orcid.org/0000-0002-8476-378X

Contact details

University of Zurich
Binzmühlestrasse 14/23
Zurich
8050
Switzerland
+41 44 635 73 84
celine.stadelmann@psychologie.uzh.ch

Type

Public

Additional contact

Prof Guy Bodenmann

ORCID ID

Contact details

University of Zurich
Department of Psychology
Binzmuehlestrasse 14
Box 1
Zurich
8050
Switzerland
+41 44 635 75 33
guy.bodenmann@psychologie.uzh.ch

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

1.0

Study information

Scientific title

Parental relationship and child development: a study protocol for a randomized controlled trial for strengthening couples and children from pregnancy until four years after birth

Acronym

RCT

Study hypothesis

We aim to strengthen couples during the transition to parenthood by increasing their awareness of the impact of the transition to parenthood on their relationship and teaching them potentially crucial relational skills with cognitive-behavioural training (within the high dose intervention) or with a psycho-educational movie (within the low dose intervention).

Ethics approval

Approved 18/12/2013, the Ethics Review Board of the Philosophical Faculty of the University of Zurich, Switzerland (University of Zurich, Department of Psychology, Cognition Psychology Unit, Binzmühlestrasse 14/22, CH-8050 Zurich, Switzerland; +41 44 63 57470; k.oberauer@psychologie.uzh.ch), ref: 7.2.6 and ref: 18 12 2013.

Study design

This randomized controlled trial is a multimodal prospective longitudinal study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Home

Trial type

Quality of life

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Relational well-being (i.e., relationship satisfaction)

Intervention

Randomization and Blinding
Couples are randomly assigned to the three treatment conditions (low dose, high dose, waiting list control) after completing measures at T1 by the study coordinator using block randomization of 10 couples per group. In case of logistical and administrative problems (trainings are only deliverable at two sites) couples are randomly assigned to the low-dose or control condition. Participants are informed about group membership via e-mail after randomization. Except from study coordinators, all involved researchers, data collectors and behavioural coders are blinded about group membership. They are not unblinded under any circumstances.

High dose intervention (skills training)
The high dose intervention group participates in the Couple Care and Coping for Parents programme (CCC-P), which is a blend of two evidence-based relationship education programmes: the Couples Coping Enhancement Training (CCET) [35] and Couple CARE for Parents [36]. CCC-P is a one-day workshop, delivered by a licensed psychologist at the 30th week of pregnancy. The workshop consists of psycho-educational and self-reflection elements and a strong focus on the behavioural training of relational skills (communication, dyadic coping, problem-solving, self-regulation in relationships). With respect to specific needs during TTP, additional topics are addressed (i.e., role changes, task distribution, sleep and sexuality after birth). The core components of the workshop are dyadic exercises, where couples are prompted by trained psychologists (ratio: two couples per one trainer) in improving their communication, dyadic coping and problem-solving. Three types of conversations are trained (couple conflict (internal stress), positive experience with the partner (wishes) and an external stress experience, meaning an individual stressor of each partner). To promote constructive communication, both partners are alternately in the role of speaker and listener and are encouraged to apply speaker and listener rules. For strengthening stress-related self-disclosure, listening and appropriate dyadic coping, couples are trained in the three-phase-method. Within problem-solving, couples learn the six-step-problem solving technique. To ensure full privacy, each couple performs the training exercises in separate rooms. Couples are coached in every second conversation. During the five home visits, a midwife continues the skills training at couples’ homes (2 hours). Additionally, partners receive self-reflection and self-regulation tasks about a certain topic (e.g., infant care, parental self-efficacy, affection and sexuality, division of labour, expectations regarding the future).

Low dose intervention (psycho-education)
Participants in the low dose group are asked to watch an interactive movie, including psycho-education on changes related to TTP. Short theoretical inputs are rounded off by narrated experiences of six couples that recently became parents and talk about changes related to the birth of their child with regards to sleep and energy, household division, mutual support, and sexuality. The movie aims at increasing couples’ awareness of challenges emerging during TTP and contains tips on relational skills, but no coaching exercises. At the end of the movie, ideas about how to implement gained knowledge into daily life are provided. Each couple receives an individual access code via e-mail to stream the movie or a hard copy if preferred. To check if couples watch the movie, the online access to the movie is tracked and couples are asked questions about it.

Waiting list control
The waiting list control condition consists of the treatment as usually offered by hospitals after the birth of the child (TAU) and contains no comparable intervention elements of the couple-focused intervention as offered to the low and high dose group. After completion of the first nine time points, couples in this group can either watch the movie or participate in the workshop.

We investigate treatment as usual as a control group to establish the natural development of relationships to which we can compare the development with the intervention.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Relational skills are measured using couple observations (at 27th, 32nd week of pregnancy, at 14th week after birth, at 3 and 4 years after birth) and self report questionnaires (at 27th, 32nd week of pregnancy, 2nd, 14th, 40th week after birth, at 3 and 4 years after birth).

Secondary outcome measures

1. Individual and relational well-being (at every measurement point: 27th, 32nd week of pregnancy, 2nd, 3rd, 6th, 9th, 12th, 14th, 12th week after birth, and 4 years after birth) and co-parenting are measured using self-report questionnaires (at 3 and 4 years after birth).
2. Child outcomes are measures using parent-report questionnaires (2nd, 3rd, 6th, 9th, 12th, 14th, 12th week after birth, and 4 years after birth) and parent-child observations (3 years after birth).

Overall trial start date

01/03/2012

Overall trial end date

01/06/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Mixed-sex committed relationship of at least one-year duration.
2. Becoming parents for the first time.
3. Speaking and understanding German.

Participant type

Healthy volunteer

Age group

Mixed

Gender

Both

Target number of participants

210

Participant exclusion criteria

1. Have children from previous relationships.
2. Twins.
3. Mental disorders of the mother.
4. Currently in treatment for psychological, physical or relational problems.
5. Couples are excluded retrospectively if birth complications arise.

Recruitment start date

01/03/2014

Recruitment end date

01/11/2015

Locations

Countries of recruitment

Switzerland

Trial participating centre

University of Zurich
University of Zurich, Binzmühlestrasse 14/23, 8050 Zurich, Switzerland
Zurich
8050
Switzerland

Sponsor information

Organisation

Swiss National Science Foundation

Sponsor details

Wildhainweg 3
Postfach
Bern
3001
Switzerland
+41 31 308 22 00
desk@snf.ch

Sponsor type

University/education

Website

http://www.snf.ch

Funders

Funder type

Charity

Funder name

Schweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung

Alternative name(s)

Swiss National Science Foundation, Fonds National Suisse de la Recherche Scientifique, Fondo Nazionale Svizzero per la Ricerca Scientifica, Fonds National Suisse, Fondo Nazionale Svizzero, Schweizerischer Nationalfonds, SNF, SNSF, FNS

Funding Body Type

private sector organisation

Funding Body Subtype

Trusts, charities, foundations (both publically funded and privately funded)

Location

Switzerland

Results and Publications

Publication and dissemination plan

Data processing will be divided between investigators in accordance with their research focus and the authorship regulations. Results will be published in peer-reviewed scientific journals in accordance to international standards. Participants will be informed about results and conclusions.

IPD sharing statement: the datasets generated during the trial will be available upon request. To request access contact the main study contact (Guy Bodenmann, guy.bodenmann@psychologie.uzh.ch). Data will be available from 01/03/2021. Only depersonalized encoded data will be made available. Consent from participants was obtained.

Intention to publish date

01/09/2019

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

22/08/2019: Trial's existence confirmed by the Ethics Commission of the Faculty of Philosophy of the University of Zurich and the Swiss National Science Foundation.