An interventional study of Grief and Communication Family Intervention in Grief and Communication, sponsored by Ersta Sköndal University College. Completed at 1 site in Sweden. Per ClinicalTrials.gov, last updated 2020-08-12.
Sponsored by Ersta Sköndal University College · Not applicable, Interventional, and Supportive care
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.
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.
719 studies on the registry are indexed under Communication; 159 are open to participants now.
This study's enrollment of 24 is below the median of 144 across 571 interventional studies indexed under Communication.
Browse Communication studies →Ersta Sköndal University College is the lead sponsor of 13 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
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
Thie Group will receive all three sessions of the grief and communication family intervention.
Behavioral: Grief and Communication Family Intervention
Group three will be the control group and will not receive the grief and communication family intervention.
This intervention is an integrative approach which uses techniques from systemic family therapy as well as cognitive behavioral therapy.
Parent-Adolescent Communication Scale
questionnaire- scores between 20-100 with higher scores indicating better family communication.
Time frame: Change from baseline score at one month, six month, and 18 month follow up
The Prolonged Grief Disorder Inventory PG-13
questionnaire- scores range between 11-55 higher scores indicate more symptoms of prolonged grief
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: Change from baseline score at one month, six month, and 18 month follow up
Plan to share: No
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This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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Ersta Sköndal University College