Grief and Communication Family Intervention

Sponsor
Ersta Sköndal University College (Other)
Overall Status
Completed
CT.gov ID
NCT03351582
Collaborator
(none)
24
1
3
23.5
1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Grief and Communication Family Intervention
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Family Support for Grief and Communication
Actual Study Start Date :
Jan 15, 2018
Actual Primary Completion Date :
Dec 31, 2019
Actual Study Completion Date :
Dec 31, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Parent-Adolescent Communication Scale [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 Outcome Measures

  1. The Prolonged Grief Disorder Inventory PG-13 [Change from baseline score at one month, six month, and 18 month follow up]

    questionnaire- scores range between 11-55 higher scores indicate more symptoms of prolonged grief

  2. Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) [Change from baseline score at one month, six month, and 18 month follow up]

    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

  3. Montgomery-Åsberg Depression Rating Scale [Change from baseline score at one month, six month, and 18 month follow up]

    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

  4. The Generalized Anxiety Disorder scale (GAD-7) [Change from baseline score at one month, six month, and 18 month follow up]

    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

  5. The Strengths and Difficulties Questionnaire (SDQ) [Change from baseline score at one month, six month, and 18 month follow up]

    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.

  6. Trauma cognitions checklist [Change from baseline score at one month, six month, and 18 month follow up]

    Parent report of children's PTSD symptoms. Scores range from 9-27 with higher scores indicating more PTSD symptoms

  7. Rosenberg self-esteem scale [Change from baseline score at one month, six month, and 18 month follow up]

    questionnaire- scores range between 10-40 with higher scores indicating higher self-esteem

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Private clinic Stockholm Sweden

Sponsors and Collaborators

  • Ersta Sköndal University College

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Josefin Sveen, Associate professor in medical psychology, Ersta Sköndal University College
ClinicalTrials.gov Identifier:
NCT03351582
Other Study ID Numbers:
  • DRN 2016/1192/31/1
First Posted:
Nov 24, 2017
Last Update Posted:
Aug 12, 2020
Last Verified:
Aug 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Josefin Sveen, Associate professor in medical psychology, Ersta Sköndal University College

Study Results

No Results Posted as of Aug 12, 2020