The Attachment, Regulation and Competency (ARC) Framework

Justice Resource Institute

Status: Completed

Conditions: Posttraumatic Stress Disorder; Developmental Trauma Disorder

Treatments: Behavioral: Attachment Regulation and Competency; Behavioral: Treatment as usual

Study type: Interventional

Funder types: Other

Identifiers

NCT05155228

JRI 2016-03

Details and patient eligibility

About

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.

Full 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.

Enrollment: 101 patients

Sex: All

Ages: 8 to 16 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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101 participants in 2 patient groups

Attachment Regulation and Competency

Experimental group

Description:

Weekly individual psychotherapy for 24 weeks using the Attachment Regulation and Competency intervention.

Treatment:

Behavioral: Attachment Regulation and Competency

Treatment as usual

Active Comparator group

Description:

Weekly individual psychotherapy for 24 weeks.

Treatment:

Behavioral: Treatment as usual