Clinical Trial: A Family-Centered Intervention When a Parent is Cared for in Specialized Homecare

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Family-Centered Intervention When a Parent is Cared for in Specialized Homecare

Brief Summary: The overall purpose of this project is to evaluate a family-centered intervention (the Family Talk Intervention, by W. Beardslee) in families where a parent of children aged 6-19 years is seriously ill and cared for in specialized homecare. The aims of the intervention are to increase family communication, the families' awareness of the impending death and their knowledge about the cancer illness, and thereby reduce the family members' long-term psychological distress.

Detailed Summary:

The death of a parent is one of the most traumatic events that can happen to a Child. In our previous research, we have found that a lack of medical knowledge, communication and awareness of impending death increased long-term psychological morbidity among bereaved family members. Unfortunately, very few clinical interventions in palliative care have been conducted in Sweden.There is therefore a need to develop and evaluate interventions that aim to decrease the risk for psychological morbidity in families affected loss.

The overall purpose of this project is to evaluate a family-centered intervention (the Family Talk Intervention, by W. Beardslee) in families where a parent of children aged 6-19 years is seriously ill and cared for in specialized homecare. The aims of the intervention are to increase family communication, the families' awareness of the impending death and their knowledge about the cancer illness, and thereby reduce the family members' long-term psychological distress.

This study is a family-based intervention study among families where a parent of young children is seriously ill. It involves an intervention group and a comparison group. The two groups will consist of families where the seriously ill parent has at least one child in the age range 6-19 years. Around thirty families will be recruited by two interventionists through two specialized homecare unit in Stockholm and this is expected to take about 18 months. Families in the comparison group (N=30) will be recruited by a research member at two other specialized homecare units in the Stockholm area.

The effect of the intervention will be measured by questionnaires to both parents and children. Questionnaire data collection will be conducted before the intervention is started (baseline, for both inter
Sponsor: Ersta Sköndal University College

Current Primary Outcome:

• Self-reported family communication, change over time [ Time Frame: Baseline (start of intervention), follow up 1 (after two months), follow up 2 (after one year). ]
  Will be measured using study specific questionnaires (6-7 years 26 items; 8-12 years 28 items; 13-19 years 52 items; patient 45 items; parent/other significant adult 54 items).
• Self-reported family communication [ Time Frame: After five weeks from the start of the intervention ]
  Will be measured by interviews

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Self -reported knowledge about the illness, change over time [ Time Frame: Baseline (start of intervention), follow up 1 (after two months), follow up 2 (after one year). ]
  Will be measured using study specific questionnaires (6-7 years 26 items; 8-12 years 28 items; 13-19 years 52 items; patient 45 items; parent/other significant adult 54 items).
• Self -reported knowledge about the illness [ Time Frame: After five weeks from the start of the intervention ]
  will be measured by interviews
• Self-reported psychological distress, change over time [ Time Frame: Baseline (start of intervention), follow up 1 (after two months), follow up 2 (after one year). ]
  Will be measured using questionnaires "The pediatric quality of Life inventory" (PEDS QL) (6-7 years 15 items; 8-19 years 16 items). "Generalized Anxiety Disorder Assessment" (GAD-7) for the adults (8 items).

Original Secondary Outcome: Same as current

Information By: Ersta Sköndal University College

Dates:
Date Received: April 3, 2017
Date Started: March 1, 2017
Date Completion: September 2019
Last Updated: April 12, 2017
Last Verified: April 2017