Grief and Communication Family Intervention

Family Support for Grief and Communication

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.

Study Overview

• Status: Completed
• Conditions: Communication; Grief
• Intervention / Treatment: Behavioral: Grief and Communication Family Intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden
    • Private Clinic

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Grief and Communication One Session; Group one will meet with a family therapist for one 90 minute session where the main focus will be on providing psychoeducation on grief and communication to both children and parents. This arm receives only the first session of the grief and communication family intervention.	Behavioral: Grief and Communication Family Intervention; This intervention is an integrative approach which uses techniques from systemic family therapy as well as cognitive behavioral therapy.
Experimental: Grief and Communication Three Sessions; Thie Group will receive all three sessions of the grief and communication family intervention.	Behavioral: Grief and Communication Family Intervention; This intervention is an integrative approach which uses techniques from systemic family therapy as well as cognitive behavioral therapy.
No Intervention: Control; Group three will be the control group and will not receive the grief and communication family intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parent-Adolescent Communication Scale	questionnaire- scores between 20-100 with higher scores indicating better family communication.	Change from baseline score at one month, six month, and 18 month follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Prolonged Grief Disorder Inventory PG-13	questionnaire- scores range between 11-55 higher scores indicate more symptoms of prolonged grief	Change from baseline score at one month, six month, and 18 month follow up
Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)	questionnaire-The items are rated on a 5-point scale with response descriptors 0 ''not at all'' to 4 ''extremely''. Total scores range from 0 to 80 and a preliminary cut-off score of 33 is suggested as indicating PTSD	Change from baseline score at one month, six month, and 18 month follow up
Montgomery-Åsberg Depression Rating Scale	questionnaire-The MADRS was used to assess symptoms of depression. It consists of 9 items. Each item is scored on a 6-point Likert scale. The total score is calculated by summing the answers of the nine items, ranging between 0 and 54 and a higher score indicates a greater risk of depression. Cut off is usually put at 10 for mild depression, 20 for moderate depression and >34 for severe depression	Change from baseline score at one month, six month, and 18 month follow up
The Generalized Anxiety Disorder scale (GAD-7)	The GAD-7 was used to assess symptoms of anxiety. It consists of 7 items, scored on a 4-point scale to the response categories from "not at all" to "nearly every day", and adding together the scores for the seven questions. Total scores of 5, 10, and 15 are taken as the cut-off for mild, moderate and severe anxiety, respectively. When used as a screening tool, further evaluation is recommended when the score is 10 or more	Change from baseline score at one month, six month, and 18 month follow up
The Strengths and Difficulties Questionnaire (SDQ)	questionnaire- subscale externalizing symptoms scores range from 0-20 with higher scores indicating more internalizing problems. Externalizing subscale scores range from 0-20 with higher scores indicating more externalizing problems.	Change from baseline score at one month, six month, and 18 month follow up
Trauma cognitions checklist	Parent report of children's PTSD symptoms. Scores range from 9-27 with higher scores indicating more PTSD symptoms	Change from baseline score at one month, six month, and 18 month follow up
Rosenberg self-esteem scale	questionnaire- scores range between 10-40 with higher scores indicating higher self-esteem	Change from baseline score at one month, six month, and 18 month follow up

Collaborators and Investigators

• Sponsor: Ersta Sköndal University College
• Investigators: Principal Investigator: Josefin Sveen, PhD, Ersta Sköndal University College

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2018
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: November 14, 2017
• First Submitted That Met QC Criteria: November 21, 2017
• First Posted (Actual): November 24, 2017

Study Record Updates

• Last Update Posted (Actual): August 12, 2020
• Last Update Submitted That Met QC Criteria: August 11, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: family therapy; psychological health
• Other Study ID Numbers: DRN 2016/1192/31/1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No