A Feasibility Randomised Control Trial to Evaluate Early Perinatal Bereavement Counselling for Parents Who Have Experienced a Perinatal Death

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16+
SponsorUniversity of Manchester

About this trial

The goal of this feasibility randomised control trial is to determine if a trial to evaluate perinatal bereavement counselling for parents who have experienced a perinatal death is feasible. The main question it aims to answer is:

• Is a trial to evaluate access to perinatal bereavement counselling feasible?

Researchers will compare the intervention group (parents who have received counselling) to the control group (parents who have not received counselling) to see if there are differences in measurements of parents' grief and psychological symptoms.

* Participants allocated to the intervention and control group will receive usual bereavement care from the perinatal bereavement team at the hospital * Parents allocated to the intervention group will receive counselling * Parents will complete validated psychometric questionnaires about their levels of perinatal grief, psychological distress, depression, and quality of life * Parents in the intervention group will be asked a series of open-ended written questions about their experience of participating in the trial * Healthcare professionals who have been involved with delivery of the intervention/referrals will be interviewed about their experience of the trial.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Women and partners of women who have had a late fetal loss (from 16 weeks), stillbirth or neonatal death within the maternity unit at Wythenshawe Hospital.

For the qualitative interviews, healthcare professionals who have been involved with referrals to the intervention and/or the delivery of the intervention

Disqualifiers

Less than 16 years of age

Anyone who lacks the capacity to consent

Inability to read English (interpreters will be provided for counselling sessions and interviews if needed).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Bereavement Counselling

    Other intervention

    Bereavement counselling for 6-8 sessions over a 3-month period beginning 3-4 months after a perinatal death

  • Usual bereavement care

    Other intervention

    Routine hospital bereavement care: regular phone calls, face-to-face meetings, access to bereavement resources via Padlet, invitations to coffee mornings, information about SANDS (Stillbirth and Neonatal Death Society) groups, and referrals to apps to access support

Treatment groups

26 Participants
are divided into 2 treatment groups
Group A: Bereavement CounsellingExperimental treatment 2 interventions
Group B: Usual bereavement careActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Participants' psychological outcomes - Perinatal Grief - assessed by the Perinatal Grief Scale (PGS; Toedter et al., 1988)

Perinatal Grief Scale (PGS; Toedter et al., 1988). 1 (Strongly Agree) to 5 (Strongly Disagree). Higher scores mean a worse outcome. Completed by participants online via Qualtrics.

Time frame
Baseline
2

Participants' psychological outcomes - Perinatal Grief - assessed by the Perinatal Grief Scale (PGS; Toedter et al., 1988)

Perinatal Grief Scale (PGS; Toedter et al., 1988). 1 (Strongly Agree) to 5 (Strongly Disagree). Higher scores mean a worse outcome. Completed by participants online via Qualtrics.

Time frame
7-9 months postnatal
3

Participants' psychological outcomes - Perinatal Grief - assessed by the Perinatal Grief Scale (PGS; Toedter et al., 1988)

Perinatal Grief Scale (PGS; Toedter et al., 1988). 1 (Strongly Agree) to 5 (Strongly Disagree). Higher scores mean a worse outcome. Completed by participants online via Qualtrics.

Time frame
12 months postnatal
4

Participants' Psychological Outcome - Distress - Assessed by the Clinical Outcomes in Routine Evaluation (CORE-10) score (Barkham et al., 2013)

Clinical Outcomes in Routine Evaluation (CORE-10) score (Barkham et al., 2013). 0 (Not At All) to 4 (Most of the Time). Higher scores mean a worse outcome. Completed by participants online via Qualtrics.

Time frame
Baseline

Secondary outcomes

1

Descriptions of participants' experiences of their involvement in the study

Open-ended questions requiring a written response on the second questionnaire for intervention participants

Time frame
7-9 months post-loss
2

Descriptions of healthcare professionals' experiences of their involvement in the study

Semi-structured interviews with 4 healthcare professionals involved in the trial

Time frame
One interview for 50 minutes 1-2 weeks following the end of the trial

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: