A pilot study of a couple−based intervention in the antenatal and early postnatal period to reduce discord
| ISRCTN | ISRCTN12258825 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12258825 |
- Submission date
- 29/04/2020
- Registration date
- 01/05/2020
- Last edited
- 22/09/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Although some conflict and discord is a normal feature of any couple relationship, research shows that some kinds of discord and conflict between parents can be harmful to infants and children. This project aims to develop and pilot the use of a brief couple-focused intervention addressing inter-parental discord/conflict in the antenatal and early postnatal period.
Who can participate?
Couples aged 18 years or older, expecting their first baby, willing and able to take part in the study.
What does the study involve?
Couples expecting their first child will be approached in the maternity departments of the Royal Free Hospital and University College Hospital. Those who meet eligibility criteria and agreed to participate will be randomly assigned to the intervention group or to usual care but with visits from the research team to collect data on outcome measures. Those allocated to the experimental group will be offered a package of three sessions antenatally and two in the early postnatal period. The sessions will be offered at the Tavistock clinic or, if preferred, at home. The aim of the intervention is to address any areas of conflict/discord within the couple relationship in the context of the couple’s transition to parenthood. Data on outcome measures is collected during short visits from a researcher at the start of the study and again when the baby is six months old. Data will be also collected remotely approximately 6 weeks after the baby's birth. Outcomes include the impact on the couple relationship, inter-parental conflict strategies, parent mental health, parent alcohol use and child development, measured using questionnaires.
What are the possible benefits and risks of participating?
Couples therapy is a ‘talking treatment’, so there were no physical risks to participants. Participants were advised that if they experienced distress through participating in the study (irrespective of treatment allocation), they should make contact with a member of the research team, who would work to provide appropriate support for the participant and/or their partner. In terms of benefits, it was anticipated that those receiving the therapy would show reduced levels of conflict and better relationship satisfaction across the transition to parenthood. For both treatment and control groups, involvement in the study was expected to have possible benefits by alerting couples that an increase in discord was to be expected across the transition to parenthood.
Where is the study run from?
1. Royal Free Hospital (UK)
2. University College Hospital (UK)
When is the study starting and how long is it expected to run for?
October 2006 to November 2009
Who is funding the study?
Mental Health Foundation (UK)
Who is the main contact?
Dr Rob Senior, rsenior@tavi-port.nhs.uk
Dr Eilis Kennedy, ekennedy@tavi-port.nhs.uk
Contact information
Scientific
Tavistock & Portman NHS Foundation Trust
120 Belsize Lane
London
NW3 5BA
United Kingdom
| Phone | +44 (0)20 7435 7111 |
|---|---|
| rsenior@tavi-port.nhs.uk |
Scientific
Tavistock & Portman NHS Foundation Trust
120 Belsize Lane
London
NW3 5BA
United Kingdom
 ORCID ID |
0000-0002-4162-4974 |
|---|---|
| Phone | +44 (0)20 7435 7111 |
| ekennedy@tavi-port.nhs.uk |
Study information
| Study design | Multi-centre parallel randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Inter−parental discord: A pilot study of a couple−based intervention in the antenatal and early postnatal period to reduce discord |
| Study objectives | Parents who receive the intervention will report better relationship quality, reduced inter-parental conflict, improved parent mental health, and fewer reported child temperamental difficulties, compared to those receiving treatment as usual across the transition to parenthood. |
| Ethics approval(s) | Approved 17/04/2007, Camden and Islington Community Local Research Ethics Committee (Room 3/14, Third Floor, West Wing, St. Pancras Hospital, 4 St. Pancras Way, London, NW1 0PE; +44 (0)207 530 3799), ref: 07/Q0511/3 |
| Health condition(s) or problem(s) studied | Inter-parental conflict during the perinatal period in couples becoming first-time parents |
| Intervention | Participants will be randomly allocated to receive TMT or TAU. TMT: Three sessions of couples therapy were offered in the antenatal period, and two in the early postnatal period. The intervention was delivered by three experienced couple psychotherapists based at the Tavistock and Portman NHS Foundation Trust and the Royal Free Hospital. The intervention was developed for the purpose of this study, based on the extant literature. Intervention content took a psycho-educational and solution-focused approach to examining the impact of inter-parental conflict on child development, and exploring ways to address it during the transition to parenthood. The couple's conflict management approaches were explored, and where appropriate, couples were helped to find alternative strategies. All sessions involved both members of the couple. TAU: Usual care with no specific psychosocial intervention. Those in the treatment group had five therapy sessions with a senior psychotherapist, either at home or at the Tavistock Clinic. The first session took place at 30 weeks of pregnancy, the second at 36 weeks, the third 12 weeks after the birth, the fourth 16 weeks after the birth, and the fifth 20 weeks after birth. Couples completed outcome measures at the first research visit (conducted at approximately 28 weeks into the pregnancy), and at the second research visit when the child was 6 months old. In addition, couples returned a postal questionnaire 6 – 8 weeks after the birth of the baby. Randomisation was conducted by an off‐site statistician based at Leeds Clinical Trials Unit with no other contact with the trial. Allocation concealment was facilitated using sequentially numbered sealed envelopes for consecutive and eligible study participants. The researchers were not blinded to allocation condition, as they were responsible for communication of the allocation to participants at the first research visit (subsequent to completion of questionnaires), and managing any disappointment that it triggered. |
| Intervention type | Behavioural |
| Primary outcome measure | Collected at baseline (after the 20 week scan), approximately 6 weeks after the birth of the infant, and when the infant was six months old: 1. Relationship quality in cohabiting couples measured using the Dyadic Adjustment Scale 2. Conflict management approaches measured using the Revised Conflict Tactics Scale |
| Secondary outcome measures | Collected at baseline (after the 20 week scan), approximately 6 weeks after the birth of the infant, and when the infant was six months old. The Bates Infant Characteristic Questionnaire was collected only at the two time-points after the child's birth. 1. Mood symptoms during pregnancy and postpartum measured using the Edinburgh Postnatal Depression Scale 2. Symptoms of depression (7 items) and anxiety measured using the Hospital Anxiety and Depression Scale 3. Alcohol disorders and hazardous alcohol intake measured using the Alcohol Use Disorders Identification Test 4. Infant characteristics measured using the 20-item Bates Infant Characteristic Questionnaire (6-month version) |
| Overall study start date | 01/10/2006 |
| Completion date | 02/11/2009 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 120 (60 couples) |
| Total final enrolment | 120 |
| Key inclusion criteria | 1. Couples expecting their first baby 2. No current serious medical or psychiatric complications 3. Both the parents of the expected baby sufficiently involved in the pregnancy to agree to participate 4. Sufficient competence in English to benefit from the therapeutic intervention and complete questionnaires 5. Couples must be over the age of 18 years old 6. Must be attending maternity services at one of the recruitment centres |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 01/05/2007 |
| Date of final enrolment | 01/12/2008 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
London
NW3 2QG
United Kingdom
London
WC1E 6DB
United Kingdom
Sponsor information
Hospital/treatment centre
120 Belsize Lane
London
NW3 5BA
England
United Kingdom
| Phone | +44 (0)20 7435 7111 |
|---|---|
| jpetty@tavi-port.nhs.uk | |
| Website | https://tavistockandportman.nhs.uk/ |
"ROR" |
https://ror.org/04fx4cs28 |
Funders
Funder type
Charity
No information available
Results and Publications
| Intention to publish date | 01/07/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available as consent was not obtained from participants to use the data for analyses other than evaluation of the efficacy of the intervention. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 21/09/2021 | 22/09/2021 | Yes | No |
Editorial Notes
22/09/2021: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.
01/05/2020: Trial’s existence confirmed by Camden and Islington Community Local Research Ethics Committee.
