Clinical trial NCT03351582: Grief and Communication Family Intervention
Official title: Family Support for Grief and Communication
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Grief
Communication
Keywords: family therapy
psychological health
Lead sponsor: Ersta Sköndal University College
Sponsor class: OTHER
First posted: 2017-11-24
Enrollment: 24
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Parent-Adolescent Communication Scale
timeFrame: Change from baseline score at one month, six month, and 18 month follow up
Secondary outcomes:
measure: The Prolonged Grief Disorder Inventory PG-13
timeFrame: Change from baseline score at one month, six month, and 18 month follow up
measure: Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
timeFrame: Change from baseline score at one month, six month, and 18 month follow up
measure: Montgomery-Åsberg Depression Rating Scale
timeFrame: Change from baseline score at one month, six month, and 18 month follow up
measure: The Generalized Anxiety Disorder scale (GAD-7)
timeFrame: Change from baseline score at one month, six month, and 18 month follow up
measure: The Strengths and Difficulties Questionnaire (SDQ)
timeFrame: Change from baseline score at one month, six month, and 18 month follow up
measure: Trauma cognitions checklist
timeFrame: Change from baseline score at one month, six month, and 18 month follow up
measure: Rosenberg self-esteem scale
timeFrame: Change from baseline score at one month, six month, and 18 month follow up
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Private clinic
Study officials:
affiliation: Ersta Sköndal University College
name: Josefin Sveen, PhD
role: PRINCIPAL_INVESTIGATOR
References: