A controlled study examining CBT for bereaved children.|
|- candidate number||14330|
|- NTR Number||NTR3854|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||5-feb-2013|
|- Secondary IDs||NL30528.041.09 CCMO|
|- Public Title||A controlled study examining CBT for bereaved children.|
|- Scientific Title||A randomised controlled trial examining the effect of a cognitive behavioural treatment for bereaved children combined with parental support.|
|- hypothesis||In the past years there is growing recognition of a syndrome of disturbed grief referred to as Prolonged Grief Disorder (PGD). Although mostly studied in adults, clinically significant PGD symptoms have also been observed in children and adolescents. To date, no effective treatment for childhood PGD yet exists. We want to investigate a cognitive behavioural therapy (CBT) treatment for bereaved children in a randomised controlled trial.|
|- Healt Condition(s) or Problem(s) studied||Bereaved children, Cognitive behavior therapy|
|- Inclusion criteria||1. Children aged 8-18 years;|
2. Suffered the loss of a loved one at least six months ago;
3. Minimal score of 40 on the Dutch version of the Inventory of Prolonged Grief (IPG);
4. Presence of a specific need for help in comping to terms with their loss.
|- Exclusion criteria||1. Severe suicide ideation with child or parent(s);|
2. Receiving concurrent psychosocial help;
3. Alcohol of drug abuse with child or parent(s);
4. The child having mental retardation;
5. Child being diagnosed with autism, behavioural disorders (ODD, CD), or severe ADHD.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-feb-2010|
|- planned closingdate||1-jun-2014|
|- Target number of participants||160|
|- Interventions||This proposed randomised controlled trial seeks to examine the effect of "Grief-Help", a cognitive behavioural treatment for children with emotional problems following the death of a loved one. Participants are randomly assigned to two treatment conditions:|
1. The experimental treatment ("Grief-Help" combined with parental support);
2. A control treatment consisting of supportive counseling combined with parental support.
Cognitive behavioural therapy:
Cognitive behavioural therapy (CBT) for childhood PGD is based on a cognitive behavioural framework that postulates that symptoms of acute grief persist and exacerbate to the point of impairment in people with PGD. The treatment consist of nine individual sessions with the children combined with five counseling sessions with the (surviving) parent(s) or other caretaker(s).
The treatment is divided into five main parts, all described in a workbook the child use throughout treatment. In the first part of treatment (titled “Who died?”), the child is invited to talk about facts of the loss and things she misses and wished she could still share with the lost person. An important aim of this part is to encourage confrontation with the reality and pain of the loss for the client, and for the therapist to gather information about maladaptive thinking and behavioural patterns that are to be addressed later on in treatment. In the second part of the treatment (titled “What is grief?”) a task-model (comparable to Worden’s task-model of grief (e.g., Worden, 1996) is introduced. The model explains four tasks bereaved children are faced with in coming to terms with loss and the processes that may block achievement of these tasks (i.e., Task 1: Facing the reality and pain of the loss; Task 2: Regaining confidence in yourself, other people, life, and the future; Task 3: Focusing on your own problems and not only those of others; Task 4: Continuing activities that you used to enjoy). The model provides a framework for interventions applied in the next stages of the treatment. For instance, in the third part (“Cognitive Restructuring”) cognitive restructuring is used to work on Task 2. The fourth part of the treatment (titled “Maladaptive Behaviours”) targets maladaptive coping behaviours. Furthermore, graded exposure interventions are used to work on Task 1, problem solving skills are taught to address Task 3, and behavioural activation is used to help achievement of Task 4. In the fifth and final part of treatment (“Moving Forward after Loss”) the skills that are learned during the treatment are reviewed, summarized, and written down. Additionally, a plan is discussed for continued practice of learned skills. Specific attention is paid to what the child could do, should his or her emotional problems exacerbate. Moreover, the child writes three letters to an imaginary or real friend as a means to facilitate consolidation of the learning process and that form a document of learned skills that can be consulted after treatment.
The aim of these parent sessions is to support them in coaching their child during her therapeutic process. To this end, the therapist and parent(s) review the workbook that guides treatment and any maladaptive thinking and behavioural patterns are discussed that may block the child’s grieving process. In addition, parents are given assignments focused on spending more quality time with their child, improving communication skills, and sharing thoughts and feelings about the loss, in order to improve the parent-child relation.
Supportive counseling for childhood PGD is based on non-directive treatments for bereaved children (Bluestone, 1999; Ryan & Needham, 2001; Webb, 2002), bereaved adults (Boelen et al., 2007; De Keijser & Schut, 1991) and treatments for children with PTSD (Cohen & Mannarino, 1996). Children are encouraged to express all their feelings and thoughts about the loss in a way that fits the child. The idea is that a bereaved child is confronted with a lot of feelings and thoughts about the loss and that it can learn to cope with those feelings by expressing them. Expressing can take the form of talking and playing. It is important that the therapist encourages the child to express their feelings in their own manner (e.g. playing or making a memory-book) and that the therapist facilitates the ways of expression of the child’s choice.
As in the GriefHelp treatment, here too are nine individual sessions with the child, and five counseling sessions with the (surviving) parent(s) or other caretaker(s). The treatment is divided in 3 parts. First, the therapist will investigate which feelings and thoughts the child has about the loss and any maladaptive behaviours that the child expresses. As a second step, the therapist and child will have a closer look at all themes that have been identified in the first phase of the therapy. The child decides if she prefers to talk, play or express their feelings in any other possible way . In the last phase the therapist and child speak or play about saying goodbye to each other. There are no homework assignments given by the therapist.
Parents will talk to the therapist every two weeks. In the first session a plan is made about which themes parent(s) want to discuss and in what order that should happen. The therapist helps the parents to think about solutions for problems that they experience in supporting their child. There are no homework assignments for the parents in this treatment condition.
|- Primary outcome||The primary goal is to examine the (preventive) effects of the two treatments on symptoms of prolonged grief disorder (PGD). Accordingly, the primary dependent variable is the intensity of PGD symptoms, as assessed by the Dutch version of the Inventory of Prolonged Grief (IPG). This measure will be administered at 5 assessment moments (i.e., before the first treatment session, after the last treatment session, and 3, 6, and 12 months after the last treatment session).|
|- Secondary outcome||Apart form the effects of the treatment on symptoms of Prolonged Grief Disorder , we will also examine the effects of treatments on conduct problems, posttraumatic stress symptoms and symptoms of depression.|
|- Timepoints||The primary goal is to examine the (preventive) effects of the two treatments on symptoms of Prolonged Grief Disorder (PGD), assessed with the Dutch version of the Inventory of Prolonged Grief (IPG). This measure will be adminstered at all 5 assessment moments.|
T1: Prior to treatment;
T2: After treatment;
T3: 3 months after treatment;
T4: 6 months after treatment;
T5: 12 months after treatment.
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Prof. Dr. P.A. Boelen|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. P.A. Boelen|
|- Sponsor/Initiator ||Universiteit Utrecht, Faculteit Sociale Wetenschappen, Department Kinder- en Jeugdstudies|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||The death of a loved one is one of the most distressing an prevalent events that children can experience. Children suffering from loss have an increased chance of developing psycho-social problems.It is useful to develop interventions that are aimed at the reduction and prevention of such problems. Thus far, no such interventions are available.
This proposed randomised controlled trial (RCT) seeks to examine the effect of "Grief-Help", a cognitive behavioural treatment for children with emotional problems following the death of a loved one. Participants are randomly assigned to two treatment conditions: (1) the experimental treatment "Grief-Help" combined with parental support or (2) a control treatment consisting of supportive counseling combined with parental support. Participants are asked to complete quentionnaires before and after treatment, and at three follow-up assessment points.
We aim to include 160 children and their parents, aged 8-18 years, who all have suffered the loss of a loved one at least 6 months prior to inclusion into the study.
|- Main changes (audit trail)|
|- RECORD||5-feb-2013 - 25-feb-2013|
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