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KIDS AID Treatment Trial: Transdiagnostic therapy for children who have experienced trauma and/or major stress

A pilot randomised controlled trial of the impact of a trauma informed version of the unified protocol for transdiagnostic treatment of emotional disorders on mental health symptoms in children

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621000971831
Enrollment
30
Registered
2021-07-26
Start date
2021-08-02
Completion date
2022-07-01
Last updated
2021-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Present trauma interventions are limited in that they tend to be designed for children diagnosed with PTSD. This study aims to test an intervention that is suitable for children who have experienced trauma but are experiencing a wide range of symptoms. We want to see whether this treatment is acceptable to children and their parents, whether it is effective at reducing mental health symptoms, and whether it prevents future difficulties associated with trauma such as suicide and psychosis symptoms. We are also interested in what mechanisms the treatment may work through (e.g., emotion regulation).

Interventions

The trauma informed unified protocol for transdiagnostic treatment of emotional disorders in children is a 15 session course following the traditional unified protocol approach (Kennedy et al., 2019) with some limited modifications to ensure the treatment is trauma informed, and therefore suitable for children who have experienced trauma. These modifications include the addition of trauma psychoeducation, clinician care to limit discussion of trauma in order to not traumatise or retraumatise chi

The trauma informed unified protocol for transdiagnostic treatment of emotional disorders in children is a 15 session course following the traditional unified protocol approach (Kennedy et al., 2019) with some limited modifications to ensure the treatment is trauma informed, and therefore suitable for children who have experienced trauma. These modifications include the addition of trauma psychoeducation, clinician care to limit discussion of trauma in order to not traumatise or retraumatise children participating, addition of narrative trauma processing, clinician discretion on when to complete emotion exposure tasks, and individual therapy sessions rather than group format for children. Parent courses will continue to be run as groups. UP-C is comprised of five core treatment principles, which together target difficulties in emotional regulation and reactivity across emotional disorders (see Kennedy et al., 2019 for more information). 1. Teaching emotional awareness skills 2. Teaching cognitive flexibility and linking thoughts to sensations skills 3. Challenging maladaptive threat appraisals and negative thinking using antecedent cognitive reappraisal 4. Teaching how to prevent emotional avoidance by developing and practicing awareness and mindfulness skills 5. Teaching how to identify and modify maladaptive action tendencies through behavioural activation and exposure. For TI-UP-C the following modifications will be included: 1. Trauma psychoeducation within the emotional awareness component 2. Narrative trauma processing will be included in a graded fashion. 3. Exposure tasks will only take place as the client is ready, with extra sessions added if required to pace this. 4. A general trauma informed approach will be taken across all sessions, with care taken not to retraumatise the child. This will include clinicians developing a formulation of how the child's trauma experiences may impact their mental health, a graded approach to discussing the trauma, considering stimuli that may remind the child of their trauma and only discussing these in a graded fashion. 5. All sessions with the child included will be on an individual basis (child and parent with clinician). Parental sessions will still be run as a group. Sessions will be 60 min with the child while parents attend a 60 minute group (2-4 parents). There is also 30 minutes of parent and child work at the end, so 90 minutes in total. Sessions will run once weekly for 15 weeks. The content of the parent sessions mirrors what children are learning in their individual sessions, and includes techniques parents can use to support children with these skills (e.g., how to help them practice a skill at home). Parent groups will be run in person, with two clinicians taking the group. Parent groups will consist of at least 2 parents and no more than 6 parents. Adherence to the intervention will be measured in two ways. Sessions with children and parents will be videoed to ensure treatment fidelity. Fidelity to treatment will be assessed by randomly selecting 20% of treatment sessions from each condition, and coding these for adherence using two raters. 50% of these will be double rated to establish inter-rater reliability. Videos will be rated as (0=skill not covered, 1=skill covered). Session fidelity will also be monitored by clinician ratings of topics covered in each session, they will tick which treatment tasks they completed on session fidelity forms.

Sponsors

Rebecca Grattan
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
7 Years to 12 Years
Healthy volunteers
No

Inclusion criteria

Participants will be required to have a history of at least one traumatic event as measured by the Child Adolescent Trauma Scale and/or at least one stressful life event measured by the Coddington Negative Life Events Scale, and elevated mental health symptoms (as indicated by a score in the clinical range on the Child Behavior Checklist) suspected to have occurred or increased following the trauma or stressful life event (measured by clinical interview). Participants need to speak sufficient English.

Exclusion criteria

Participants who are experiencing severe PTSD (as measured by the KSADS), severe suicidal ideation or self-harming behaviour, have a psychotic disorder (as measured by the KSADS), have diagnosed or suspected Autism Spectrum Disorder, or have a suspected IQ <70 are not eligible. Participants who have received CBT in the past are also ineligible.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026