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Adoption-specific Treatment Prevention Pilot Trial (ADAPT)

This study is currently recruiting participants.
Verified October 2016 by Dr. Jeanne Miranda, University of California, Los Angeles
Sponsor:
ClinicalTrials.gov Identifier:
NCT01744951
First Posted: December 7, 2012
Last Update Posted: October 27, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Center for Adoption Support and Education
Information provided by (Responsible Party):
Dr. Jeanne Miranda, University of California, Los Angeles
November 28, 2012
December 7, 2012
October 27, 2016
October 2012
September 2017   (Final data collection date for primary outcome measure)
Parent Weekly Report [ Time Frame: Participants will be followed for the duration of the therapeutic intervention, an expected average of 24 weeks. ]
The Parent Weekly Report consists of two measures: Brief Problem Checklist (Chorpita et al., 2010 and Parent Daily Report (Chamberlain & Reid, 1987).
Same as current
Complete list of historical versions of study NCT01744951 on ClinicalTrials.gov Archive Site
Number of child participants whose internalizing and externalizing behaviors improve [ Time Frame: 0 weeks, 24 weeks, 36 weeks ]
Child participants' internalizing and externalizing behaviors will be measured at the three distinct times by using both child and parent measures: 1. Emotional Distress and Functioning:Children's Depression Inventory, Screen for Childhood Anxiety Related Emotional Disorders (SCARED),Child PTSD Symptom Scale (CPSS),Achenbach Child Behavior Checklists and Teacher Report Forms (CBCL),Children's Global Assessment Scale (CGAS) 2.Targeted Resilience Factors: Emotion Regulation Checklist (ER Checklist),Kidcope 3.Understanding of Adoption: Adoption Dynamics Questionnaire (ADQ),Children's Beliefs about Adoption Scale (CBAAS) 4.Family Environment and Parental Distress,Family Environment Scale (FES),Brief Symptom Inventory (BSI) 5.Attachment and Parenting: Inventory of Parent and Peer Attachment (IPPA) 6.Trauma Exposure: Modified Life Events Scale (LES) 7.Process Variables: Therapeutic Alliance Scale for Children (TASC),Working Alliance Inventory (WAI),Consumer Satisfaction Questionnaire
Same as current
Not Provided
Not Provided
 
Adoption-specific Treatment Prevention Pilot Trial
Evaluate the Adoption-specific Prevention Treatment Program (ADAPT)

This study seeks to pilot a manualized adoption-specific intervention aimed at providing a preventive intervention for families adopting children ages 5-14 years where family reunification has been terminated and the family is moving toward adoption or who have adopted children from foster care in the last three years. This work will fill a major gap in services to children and families and is developed to improve mental health and family functioning of children adopted from foster care, as well as decrease adoption disruptions. President Clinton's 1997 adoption initiative, The Adoption and Safe Families ACT (ASFA), along with subsequent Congressional initiatives, have provided incentives to States and subsidies for adopting older children with a resultant increase in rates of adoption from foster care from 26,000 in 1995 to 53,000 (stabilized annual rate) beginning in 2002. The mean age at adoption from foster care is now 6 years old. These older children have histories of physical and sexual abuse, neglect, and multiple placements, all factors that predict behavior problems over time. To address this gap in our knowledge of providing care for this vulnerable group, we have developed a manualized adoption-specific intervention for families adopting children from foster care. Because adoptive children generally enter homes with stable, well-functioning parents, interventions may be particularly effective in helping the children adjust and their parents learn to understand and manage children with difficult past histories.

The aim of this current pilot trial is to test this intervention designed to improve the outcomes for children adopted from foster care through a randomized trial. Our hypothesis is that this manualized adoption-specific intervention will be more effective than care as usual in improving child mental health and family functioning outcomes; specifically, families and children who have been randomized to the manualized adoption-specific intervention will show better outcomes on the post-treatment measures and the 3 month follow-up than on the pre-treatment measures than the care as usual families and children.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Prevent Disorders in Children Adopted From Foster Care
Behavioral: ADAPT

ADAPT consists of the following modules/sessions:

Module 1: Trust, positive coping strategies, and behavior management; Module 2: Developmental understanding of adoption experience; Module 3: Substance abuse prevention; Module 4: Loss and grief issues about birth family and foster care; Module 5: Attachment/joining with adoptive family; Module 6: Search for identity/self -esteem; Module 7: Adoption and the outside world; Module 8: Trauma Treatment (if appropriate)

  • Experimental: ADAPT
    ADAPT is a manualized intervention with eight treatment modules designed as an early intervention for children, ages 5-14, who are being adopted from foster care and their adoptive parent/s.
    Intervention: Behavioral: ADAPT
  • No Intervention: Care as usual
    Children, ages 5-14, and their adoptive parent/s will receive care as usual in the treatment setting.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
December 2017
September 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Children being adopted from foster care, ages 5-14
  • Children (within above age range) who have been adopted in the last three years
  • Family reunification services have been terminated

Exclusion Criteria:

  • Children with the following Diagnostic and Statistical Manual psychiatric disorders will be excluded from study participation: Pervasive Developmental Disorders (e.g. Asperger's, autism, mental retardation, or psychotic disorder as known to the parents
  • Children will be excluded if the child has a major neurological disorder or a major medical illness that would interfere with participation in the study
  • Children who pose a significant risk for dangerousness to self or others that makes participating inadvisable
  • Children and/or parents who are non-English speaking and unable to complete treatment without a translator will not be included
Sexes Eligible for Study: All
5 Years to 14 Years   (Child)
Yes
Contact: Jeanne Miranda, Ph.D. 310-794-3710 JMMiranda@mednet.ucla.edu
Contact: Jill Waterman, Ph.D. 310-825-3240 Waterman@psych.ucla.edu
United States
 
 
NCT01744951
ADAPT-02
UCLA IRB/IRB# 12-001024 ( Other Grant/Funding Number: Annie E Casey Foundation/212.0023 )
No
Not Provided
Not Provided
Dr. Jeanne Miranda, University of California, Los Angeles
University of California, Los Angeles
Center for Adoption Support and Education
Principal Investigator: Jeanne Miranda, Ph.D. University of California, Los Angeles
University of California, Los Angeles
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP