Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000592549
Ethics application status
Approved
Date submitted
28/03/2024
Date registered
9/05/2024
Date last updated
9/05/2024
Date data sharing statement initially provided
9/05/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The Tree of Life: an intervention with adolescent victims sex abuse
Scientific title
'The Tree of Life: a psychological treatment approach aimed at promoting protective factors of emotional bonding relationships and psychological adjustment in adolescents who have suffered sexual abuse.
Secondary ID [1] 311786 0
None
Universal Trial Number (UTN)
U1111-13-05-5832
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sex abuse 333295 0
Psychological trauma 333644 0
Condition category
Condition code
Mental Health 329982 329982 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Tree of Life intervention consists of using the parts of a tree as a metaphor to represent the different aspects of our life. The use of this metaphor invites the children to tell their story in an active process of construction, reconstruction and continuous revision of their abilities, their beliefs, their values, their dreams and hopes for the future and their relationships with the important people in their lives. To this end, each participant in the group draws his or her own tree and the therapist indicates how to cover each of the parts of the tree; subsequently a space for conversation is opened on the aspects mentioned above with the aim of giving meaning and significance to their lives and their relationships. The intervention will be developed in 8 weekly group sessions lasting an hour and a half over 4 distinct stages: drawing the tree and talking about each of the parts (4 sessions); the forest of life (1 session); the storms of life (1 session); ceremony and celebration (2 sessions). The groups will be formed by a maximum of 12 participants and the therapist of reference of each group will lead the intervention. The therapist is a psychologist.
a) First stage: Drawing of the Tree of Life (4 sessions)
- Roots: they represent our origins, our ancestors.
- Earth: represents the present moment of our lives.
- Core: knowledge, skills, values and beliefs.
- Branches: dreams and hopes for the future
- Leaves: important people in our lives.
- Fruits: the gifts that these people have given us that are related to aspects of care, help, support, affection...
- Other spontaneous drawings on the tree itself that represent the gifts that the participants have given to the important people in their lives.
During the process of drawing and describing The Tree of Life, questions are asked in each part of the participants' story to generate knowledge of themselves, in which they identify what is valuable to them, what they know how to do, what they enjoy, important relationships and what they dream of in the future.
b) Second stage: The Forest of Life (1 session). A safety island is built that allows participants to stand in a different place and from a different position. Participants share their trees and their history individually and then as a group. All the drawings are placed on a wall and participants are invited to write words of support on the other participants' trees. In this part, a safe space is created to talk about the experience of sexual abuse in the next stage. The island of security refers to the construction of a safe territory of identity in which the person understands the response to the experience of abuse as a sign of strength and resilience, instead of a sign of weakness, shame, guilt, etc., so that he/she rebuilds his/her internal belief system about trust in basic human relationships, as well as affective bonds that offer security and protection; consequently, it provides a feeling of control over his/her behaviours and emotions in difficult situations, avoiding re-victimization.
c) Third stage: The Storms of Life (1session). In this stage, the stories of actions, interactions, meanings, and knowledge that are part of the response that until now had not been told to the experience of sexual abuse become visible; People are not passive recipients of trauma (Denborough, 2008). The conversation in this stage is group, so that the recovery of the knowledge that the participants have in their ways of facing abuse is shared as a group. These shared responses generate what is called local knowledge in narrative practice (White and Epston, 1993), the richness of the lived experience.
d) Fourth stage: Ceremony and Celebration (2 sessions). This stage aims to recognize their stories of resistance, skills, and dexterity. In the original design (Ncube and Denborough, 2006), certificates were awarded to each participant in which their skills and knowledge were recognized. In this project we are also going to use the creation of a Collective Document with the aim of strengthening the reconnection with the group and creating a feeling of belonging.
The strategies used to monitor compliance with the intervention are the attendance checklist of the participants at the sessions and a record per session covered by the therapists with information regarding: number of trees covered and responses in each of the parts, degree of participation and interest in the sessions, difficulties observed, other observations of interest.
Intervention code [1] 328271 0
Treatment: Other
Comparator / control treatment
The control group is made up of participants in the Intervention Programme with Child and Adolescent Victims of Sexual Abuse in the provinces of Pontevedra (Vigo), Coruña and Orense. Like the experimental group, they will receive the pre and post measures, but will not receive the Tree of Life intervention. The control group will continue to receive their usual care based on trauma-focused cognitive behavioural therapy, in which the sessions are individual sessions every fortnight and are carried out by each adolescent's therapist of reference. It is important to note that this project is committed to carrying out the Tree of Life intervention with the participants in the control group once the research is completed. The recording strategies consist of monitoring attendance at the regular therapy sessions of the programme to which they belong.
Control group
Active

Outcomes
Primary outcome [1] 337787 0
Perceived satisfaction with bonding relationships
Timepoint [1] 337787 0
Baseline, at the end of treatment and at 3 and 6 months following end the treatment
Primary outcome [2] 337807 0
Perceived usefulness The Tree of Life
Timepoint [2] 337807 0
At the end of the treatment, 3 and 6 months following end the treatment
Primary outcome [3] 338090 0
Psychological adjustment
Timepoint [3] 338090 0
Baseline, at the end of treatment, 3 and 6 months following end the treatment
Secondary outcome [1] 433367 0
Linguistic Capacity (the language will be used to measure the linguistic and/or narrative capacity of the participants, so that the better the linguistic capacity, the greater the effectiveness of our intervention)
Timepoint [1] 433367 0
Baseline, at the end of treatment and at 3 and 6 months following end the treatment

Eligibility
Key inclusion criteria
The inclusion criteria to participate in the study are:
- Adolescents between the ages of 12 and 19.
- Adolescents who participate in the Therapeutic Intervention Program with Boys, Girls and Adolescents Victims of Sexual Abuse in the provinces of Pontevedra, Vigo, A Coruña, Ourense and Lugo.
- Have the authorization and consent of the guardians and/or legal guardians of the adolescents.
Minimum age
12 Years
Maximum age
19 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The exclusion criteria are:
- Present cognitive and/or language difficulties that prevent you from answering the questionnaires or following the therapeutic intervention.
- Present a diagnosis of serious psychological and/or psychiatric disorder.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
This research project will be carried out based on a quasi-experimental design of a non-equivalent control group with pretest and post-test measurement. Tow research groups are established:
- Group 1 (Experimental Group): receives the intervention of The Tree of Life.
- Group 2 (Control group): does not receive the intervention of The Tree of Life. It is important to mention that the control group will receive the intervention once the research process is completed to comply with the corresponding ethical guarantees.
It should be noted that the intervention will be carried out in a group format, since the literature review demonstrates the importance of perceived social support and mutual understanding when sharing similar life experiences to build a feeling of belonging to the community and to strengthen one's own personal agency (Denborough, 2008; Ncube & Denborough, 2007; Shuman, 2020). Likewise, the group nature of the intervention optimizes the resources available in social services (Jackson et al., 2009; Shuman, 2020).
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample is made up of the adolescent population that attends the Intervention Program with Boys, Girls and Adolescents Victims of Sexual Abuse, carried out by the Meniños Foundation and subsidized by the Department of Social Policy of the Xunta de Galicia. The Intervention Program with Boys, Girls and Adolescents Victims of Sexual Abuse of the Meniños Foundation conceives the intervention from a comprehensive perspective that addresses the consequences produced by CSA in the minor and focuses on the support of the family environment and closest community as an essential part of the recovery process.
DATA ANALYSES
To analyse the sociodemographic data, a descriptive statistical analysis will be carried out using SPSS v.25 in order to know the characteristics of the study sample.
Regarding the evaluation of the effectiveness of the intervention through the application of psychometric questionnaires, this will be carried out with the SPSS v statistical program. 25, through statistical tests that allow us to know the effect of the intervention in the sample. Thus, in the planned statistical analysis, on the one hand, the ANOVA of independent measures with different groups will be used to evaluate their initial equivalence, and, on the other hand, the ANOVA of repeated measures will be used in both the control group and in the experimental group to evaluate the effectiveness of the treatment.
A regression test will be used that allows us to analyse the relationship between the number of adverse experiences (covariate), socio-affective relationships and psychological adjustment (dependent variables); so that we can analyse to what extent adverse experiences would explain their relationship with the two dependent variables (socio-affective relationships and psychological adjustment).
Finally, a regression test will also be used to analyse to what extent adverse experiences would predict greater problems in the two dependent variables (socio-affective relationships and psychological adjustment) after the intervention.
For the analysis of the qualitative data collected in the qualitative questionnaire designed ad hoc, and those collected from the analysis of the conversations about the tree of life, the forest of life, the storms of life and the collective document, will be carried out using the Grounded Theory method. For the analysis of the drawings and mural resulting from the intervention, the procedure defined by Braun and Clarke (2006) will be used, which includes a thematic analysis. We will use the Atlas ti., v8 computer program for both analyses

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
27/05/2024
Actual
Date of last participant enrolment
Anticipated
30/09/2024
Actual
Date of last data collection
Anticipated
30/04/2025
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 26220 0
Spain
State/province [1] 26220 0
GALICIA (Pontevedra, Vigo, A Coruña, Ourense, Lugo)

Funding & Sponsors
Funding source category [1] 316118 0
University
Name [1] 316118 0
UNED (Universidad Nacional de Educación a Distancia)
Country [1] 316118 0
Spain
Funding source category [2] 316175 0
Other Collaborative groups
Name [2] 316175 0
Fundación Meniños
Country [2] 316175 0
Spain
Primary sponsor type
University
Name
UNED (Universidad Nacional de Educación a Distancia)
Address
Country
Spain
Secondary sponsor category [1] 318354 0
University
Name [1] 318354 0
UNEX (Universidad de Extremadura
Address [1] 318354 0
Country [1] 318354 0
Spain
Secondary sponsor category [2] 318355 0
University
Name [2] 318355 0
URJC (Universidad Rey Juan Carlos)
Address [2] 318355 0
Country [2] 318355 0
Spain
Secondary sponsor category [3] 318356 0
Other Collaborative groups
Name [3] 318356 0
Fundación Meniños
Address [3] 318356 0
Country [3] 318356 0
Spain

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314950 0
Research Ethics Committee of the Universidad Nacional a Distancia (UNED)
Ethics committee address [1] 314950 0
Ethics committee country [1] 314950 0
Spain
Date submitted for ethics approval [1] 314950 0
27/10/2023
Approval date [1] 314950 0
01/12/2023
Ethics approval number [1] 314950 0
43-SISH-PSI-2023

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 133218 0
Miss Rebeca Bastón Paz
Address 133218 0
Fundación Meniños, Avenida de Cádiz, 5, 2ªIzq, Edificio la Milagrosa, CP15008 A Coruña
Country 133218 0
Spain
Phone 133218 0
+34600515685
Fax 133218 0
Email 133218 0
[email protected]
Contact person for public queries
Name 133219 0
Rebeca Bastón Paz
Address 133219 0
Fundación Meniños, Avenida de Cádiz, 5, 2ªIzq, Edificio la Milagrosa, CP15008 A Coruña
Country 133219 0
Spain
Phone 133219 0
+34600515685
Fax 133219 0
Email 133219 0
[email protected]
Contact person for scientific queries
Name 133220 0
Carlos Alexis Chimpén
Address 133220 0
Avenida de la Universidad s/n-Norte-CP 10003- Cáceres
Country 133220 0
Spain
Phone 133220 0
+34 927 25 74 50
Fax 133220 0
Email 133220 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
only the data underlying the published results will be shared.
When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following main results publication
Available to whom?
anyone who wishes to access it
Available for what types of analyses?
only to achieve the aims in the approved proposal
How or where can data be obtained?
access subject to approvals by Principal Investigator ([email protected])


What supporting documents are/will be available?

Current supporting documents:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21998Informed consent form  [email protected]
21999Ethical approval  [email protected]
22000Other  [email protected] Sociodemographic Questionnaire, Qualitative Questi... [More Details]
22001Study protocol  [email protected]


Updated to:
Results publications and other study-related documents

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No documents have been uploaded by study researchers.

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