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Clinical Trials/NCT03351582
NCT03351582
Completed
N/A

Family Support for Grief and Communication

Ersta Sköndal University College1 site in 1 country24 target enrollmentJanuary 15, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Grief
Sponsor
Ersta Sköndal University College
Enrollment
24
Locations
1
Primary Endpoint
Parent-Adolescent Communication Scale
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

The overall purpose of this project is to evaluate the effects of a family therapy intervention for grieving families with children. The main outcome variable is family communication.

Detailed Description

The intervention study will test a supportive family therapy intervention for families where a parent has died from cancer between 2013 and 2015. This will be a randomized controlled trial where participants are assigned to one of three groups using a random number sequence generated by a computer program with approximately 25 families in each intervention group. Group one will meet with a family therapist for one 90 minute session where the main focus will be on providing information through psychoeducation on grief and communication to participants. Group two will participate in a family therapy intervention comprised of three 90 minute sessions. participants will receive the same psychoeducation as group one and will also work with the family therapist to enhance family communication and process their grief. The 3 sessions are manual based. Group three will be the control group and will not meet with a family therapist. Participants will be asked if their sessions with the family therapist can be tape-recorded, but do not have to consent to this in order to participate. Approximately 6 participants need to be recorded in order to ensure that the family therapists are covering the same topics and giving the same information to all participants. In this way we can ensure that the method of intervention is the same no matter which therapist is delivering the intervention thereby validating the method of intervention. Follow up will occur 1 month and 6 months after the intervention has ended. Each participant will fill in a short questionnaire regarding grief and Communication. Validated instruments will also be included in the questionnaire.

Registry
clinicaltrials.gov
Start Date
January 15, 2018
End Date
December 31, 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Ersta Sköndal University College
Responsible Party
Principal Investigator
Principal Investigator

Josefin Sveen

Associate professor in medical psychology

Ersta Sköndal University College

Eligibility Criteria

Inclusion Criteria

  • Participants are families with Children ages 3-19 who have completed our questionnaire study and have responses indicating that one or more family members have symptoms of complicated grief or a negative pattern of communication within the family. All family members who live in the same home may participate in the family therapy intervention including new partners or step children. It is up to the family to decide which family members will be included.

Exclusion Criteria

  • Participants must reside in Stockholm, Sweden during data collection, speak and understand written and spoken Swedish.

Outcomes

Primary Outcomes

Parent-Adolescent Communication Scale

Time Frame: Change from baseline score at one month, six month, and 18 month follow up

questionnaire- scores between 20-100 with higher scores indicating better family communication.

Secondary Outcomes

  • The Prolonged Grief Disorder Inventory PG-13(Change from baseline score at one month, six month, and 18 month follow up)
  • The Generalized Anxiety Disorder scale (GAD-7)(Change from baseline score at one month, six month, and 18 month follow up)
  • Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)(Change from baseline score at one month, six month, and 18 month follow up)
  • Rosenberg self-esteem scale(Change from baseline score at one month, six month, and 18 month follow up)
  • Montgomery-Åsberg Depression Rating Scale(Change from baseline score at one month, six month, and 18 month follow up)
  • The Strengths and Difficulties Questionnaire (SDQ)(Change from baseline score at one month, six month, and 18 month follow up)
  • Trauma cognitions checklist(Change from baseline score at one month, six month, and 18 month follow up)

Study Sites (1)

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