GriefNCT03351582
Grief and Communication Family Intervention
A study testing Grief and Communication Family Intervention in people with Grief and Communication, run by Ersta Sköndal University College at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Grief, Communication
- What is being tested?
- Grief and Communication Family Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSweden
- Study dates
- 15 Jan 2018to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Participants must reside in Stockholm, Sweden during data collection, speak and understand written and spoken Swedish.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Grief, Communication
- Being tested
- Grief and Communication Family Intervention
- Keywords
- family therapy, psychological health
- Medical subject headings
- Communication, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Grief and Communication Family InterventionBehavioural
This intervention is an integrative approach which uses techniques from systemic family therapy as well as cognitive behavioral therapy.
| Study group | Role | What they receive |
|---|---|---|
| Grief and Communication One Session | Experimental | 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. Receives: Behavioral: Grief and Communication Family Intervention |
| Grief and Communication Three Sessions | Experimental | Thie Group will receive all three sessions of the grief and communication family intervention. Receives: Behavioral: Grief and Communication Family Intervention |
| Control | No intervention | Group three will be the control group and will not receive the grief and communication family intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parent-Adolescent Communication Scale
questionnaire- scores between 20-100 with higher scores indicating better family communication.
Measured: Change from baseline score at one month, six month, and 18 month follow up
Secondary outcomes (7)
The Prolonged Grief Disorder Inventory PG-13
questionnaire- scores range between 11-55 higher scores indicate more symptoms of prolonged grief
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: Change from baseline score at one month, six month, and 18 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2017
- Study start15 Jan 2018
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GriefStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ersta Sköndal University College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Josefin Sveen, Ersta Sköndal University College
- Investigators
- Josefin Sveen, PhD, Principal investigator, Ersta Sköndal University College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03351582
- Sponsor's protocol ID
- DRN 2016/1192/31/1
- Status last verified
- Aug 2020
- First submitted
- 14 Nov 2017
- Last updated
- 12 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family Support for Grief and Communication
- ClinicalTrials.gov ID
- NCT03351582
- Acronym / sponsor ID
- DRN 2016/1192/31/1
- Conditions
- Grief, Communication
- Keywords
- family therapy, psychological health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Ersta Sköndal University CollegeUniversity, hospital or other
- Study start
- 15 Jan 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 24 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Grief and Communication One Session | Experimental | Behavioral: Grief and Communication Family InterventionGroup 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. |
| Grief and Communication Three Sessions | Experimental | Behavioral: Grief and Communication Family InterventionThie Group will receive all three sessions of the grief and communication family intervention. |
| Control | No intervention | –Group three will be the control group and will not receive the grief and communication family intervention. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Participants must reside in Stockholm, Sweden during data collection, speak and understand written and spoken Swedish.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Grief and Communication Family InterventionThis intervention is an integrative approach which uses techniques from systemic family therapy as well as cognitive behavioral therapy. | Behavioural | Grief and Communication One Session, Grief and Communication Three Sessions |
Primary outcome
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.
7 secondary outcomes
The Prolonged Grief Disorder Inventory PG-13
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)
Time frame: Change from baseline score at one month, six month, and 18 month follow up
Montgomery-Åsberg Depression Rating Scale
Time frame: Change from baseline score at one month, six month, and 18 month follow up
The Generalized Anxiety Disorder scale (GAD-7)
Time frame: Change from baseline score at one month, six month, and 18 month follow up
The Strengths and Difficulties Questionnaire (SDQ)
Time frame: Change from baseline score at one month, six month, and 18 month follow up
Trauma cognitions checklist
Time frame: Change from baseline score at one month, six month, and 18 month follow up
Rosenberg self-esteem scale
Time frame: Change from baseline score at one month, six month, and 18 month follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2020.
- Individual participant dataSharing planned: No
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Depressive Symptoms, Perinatal Loss
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Risk and Resilience to Suicide Following Late-Life Spousal Bereavement
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Recruiting
Technology-supported Interventions for Prolonged Grief Disorder (PGD)
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Recruiting
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Josefin Sveen, PhD principal investigator
Ersta Sköndal University College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Grief and Communication Family Intervention in people with Grief and Communication, run by Ersta Sköndal University College at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parent-Adolescent Communication Scale (time frame: Change from baseline score at one month, six month, and 18 month follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2020.