Clinical trial NCT05155228: The Attachment, Regulation and Competency (ARC) Framework
Official title: Evaluation of the Attachment, Regulation and Competency (ARC) Framework for the Treatment of Complex Trauma in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posttraumatic Stress Disorder
Developmental Trauma Disorder
Lead sponsor: Justice Resource Institute
Sponsor class: OTHER
First posted: 2021-12-13
Enrollment: 101
Sex: ALL
Minimum age (years): 8
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The Attachment, Regulation and Competency (ARC) Framework is an attachment focused model designed specifically for trauma-impacted children that incorporates principles of the following theoretical orientations: 1) developmental theory; 2) family systems theory; and 3) strengths-based approaches. The central goals of the ARC framework are to (a) support caregiving systems and enhance caregiver-child relationships ("Attachment"), (b) support children in developing the skills and tolerance for connecting to, identifying, and sharing internal experience and managing emotional and physiological states ("Regulation"), (c) build key capacities associated with resilience including the ability to engage in problem-solving and a positive / effective sense of self ("Competency"), and (d) process traumatic experiences.
Primary purpose: TREATMENT

Brief summary: This study evaluates the effectiveness of the Attachment Regulation and Competency (ARC) treatment framework in comparison to treatment as usual for reducing symptoms of PTSD and Developmental Trauma Disorder among children ages 8 to 16 with a history of exposure to multiple traumatic events.

Detailed description: The primary goal of this project is to expand the knowledge base in the field of trauma informed interventions by addressing current gaps in the evidence base through: a) evaluation of the efficacy of an innovative intervention designed specifically for children who experience complex trauma and their caregivers, thereby evaluating strategies that are most effective, and b) examining how ARC promotes protective factors (self-regulation, caregiver wellness), thereby supporting the health and well-being of complexly traumatized children and their families. The overall purpose of the randomized controlled trial (RCT) is to examine the effectiveness of ARC on the range of developmental disruptions and clinical symptoms that represent complex trauma, as well as its utility for increasing the adaptive functioning of children and families. In particular it is necessary to determine: 1) if ARC will demonstrate effectiveness in reducing sequelae of complex trauma as determined by a scientifically rigorous randomized control trial study design; 2) the extent to which ARC positively impacts resiliency factors (self-regulation, executive functioning, caregiver wellness), thereby serving to moderate or mediate change in symptoms and functioning; and 3) the impact of ARC across multiple levels of the family ecology, including the child, the caregiver-child relationship (i.e., attachment) and caregiver stress and wellness.

The specific objectives of this research project are the following:

1. Recruit 182 children ages 8 to 16 with complex trauma and their adult caregivers, from clinical samples of children actively seeking treatment for mental health disorders and related difficulties from three community based outpatient clinics in the Commonwealth of Massachusetts.
2. Conduct comprehensive, clinical interviews with participants and their caregivers to assess sequelae of complex trauma, to determine underlying resiliency factors and to gather information regarding trauma exposure history, over four study time points (pre-, mid-, and post-treatment and 6-month follow up).
3. Deliver 24 sessions of once weekly ARC or TAU over a 6-month intervention period.
4. Evaluate the efficacy of ARC and TAU using a variety of sophisticated statistical methods, such as growth curve modeling, multivariate analyses, and hierarchical linear regression analyses.
5. Disseminate findings to: 1) the academic community via presentations at professional conferences and publications of data in peer reviewed journals; 2) the public, via the Trauma Center website, which received over 600,000 visitors in 2012, with 1,161,451 downloads of our manuscripts and resources for providers, consumers and state service agencies; and 3) the National Child Traumatic Stress Network (NCTSN) and Complex Trauma Treatment Network (CTTN) at annual network meetings, via their websites and through ongoing collaborations with partner network sites across the country.

Eligibility criteria: Inclusion Criteria.

1. DTD diagnosis as measured by the DTD interview (using standard scoring criteria) or partial PTSD diagnosis as measured by the CAPS.
2. A history of at least two forms of trauma, at least one of which must be interpersonal in nature (sexual, physical or psychological maltreatment, neglect, abandonment or impaired caregiving) as indicated on the Trauma History Profile (THP).

Exclusion Criteria.

1. Serious illness that is not stabilized.
2. GAF \< 40.
3. Past diagnosis of autism spectrum disorder, mental retardation, or schizophrenia.
4. Current psychotic disorder or established organic impairment (e.g., TBI).
5. Active suicidal risk, self-mutilation or homicidal behavior toward others within the past 3 months, as judged by the PI.
6. Previous ARC treatment.
7. Any other condition that might interfere with the person's capacity to give informed consent, or to adhere to the study protocol.

Primary outcomes:
measure: Change in baseline symptoms of PTSD at up to 24 weeks of treatment and 6-month follow up per the Clinician Administered PTSD Scale for Children and Adolescents, DSM 5 (CAPS-CA-DSM5)
timeFrame: Change from baseline PTSD symptom severity at up to 24 weeks of treatment and 6-month follow up.
measure: Change in baseline symptoms of Developmental Trauma Disorder (DTD) at up to 24 weeks of treatment and 6-month follow up
timeFrame: Change from baseline DTD symptom severity at up to 24 weeks of treatment and 6-month follow up.
Secondary outcomes:
measure: UCLA Posttraumatic Stress Disorder -Reaction Index for DSM 5 (PTSD-RI-5)
timeFrame: Change from baseline PTSD symptom severity at up to 12-weeks of treatment, up to 24 weeks of treatment and 6-month follow up.
measure: Child Behavior Checklist (CBCL)
timeFrame: Change from baseline in internalizing and externalizing problems at up to 12 weeks of treatment, up to 24 weeks of treatment, and 6-month follow up.
measure: Behavior Rating Inventory of Executive Function - Parent Report (BRIEF-PR)
timeFrame: Change from baseline in executive dysfunction at up to 12 weeks of treatment, up to 24 weeks of treatment and 6-month follow up.
measure: Trauma Symptom Checklist for Children (TSCC)
timeFrame: Change from baseline in symptoms of dissociation at up to 12 weeks of treatment, up to 24 weeks of treatment, and 6-month follow up.
measure: NIH Toolbox for the Assessment of Neurological and Behavioral Function, Cognition Domain
timeFrame: Change from baseline in executive function at up to 12 weeks of treatment, up to 24 weeks of treatment and 6-month follow up.
Other outcomes:
measure: Behavioral and Emotional Rating Scale, Second Edition (BERS-2)
timeFrame: Change from baseline in resilience at up to 12 weeks of treatment, up to 24 weeks of treatment and 6-month follow up.
measure: Emotion Regulation Checklist (ERC)
timeFrame: Change from baseline in emotion regulation at up to 12 weeks of treatment, up to 24 weeks of treatment and 6-month follow up.
measure: Brief Symptom Inventory (BSI)
timeFrame: Change from baseline in caregiver mental health symptoms at up to 12 weeks of treatment, up to 24 weeks of treatment and 6-month follow up.
Locations:
city: Brookline
country: United States
facility: Trauma Center at JRI
state: Massachusetts
Study officials:
affiliation: Trauma Center at JRI
name: Hilary B Hodgdon, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: