Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05238766
Other study ID # IRB00292589
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 21, 2022
Est. completion date October 31, 2024

Study information

Verified date April 2024
Source Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Contact Craig W Strohmeier, Psy.D.
Phone 4439233871
Email strohmeier@kennedykrieger.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Many children with autism demonstrate severe problem behavior (SPB) in the form of self-injury, aggression, and disruptive behavior. Conducting a functional analysis and implementing derived treatments can produce effective behavior plans. Nonetheless, skills training and an effective plan may not be sufficient to produce parent adherence. This applied research proposal describes an approach to target the negative maintaining contingencies supporting parent reinforcement of problem behavior (accommodation) and nonadherence. The intervention, borrowed from Acceptance and Commitment Therapy and Behavioral Activation strategies, is matched specifically to the hypothesized function of the problematic caregiver responses (negative reinforcement). Parents who participate in the proposed investigation will be assigned to either the Defuse Experience Accept Live intervention (DEAL) protocol group or treatment as usual. Five 45-min DEAL sessions will 1) introduce caregivers to behavior change strategies that maximize contact with positive-maintaining contingencies related to adherence, while undermining the contingencies that maintain accommodation, and 2) provide caregivers with new treatment-related committed actions that are sensitive to positive changes in parent-child interactions. Within and between participant analyses will be conducted to determine the effectiveness of the DEAL protocol.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date October 31, 2024
Est. primary completion date October 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Child under the age of 18 years, - Child is diagnosed with ASD, as confirmed by the Gilliam Autism Rating Scale-3, - Child problem behavior is socially-maintained as identified via functional analysis, - Parent is English-speaking, and - Parent attendance of at least 80% of appointments at entry into the study. Exclusion Criteria: - Child is older than 18 years of age, - Child does not have ASD, - Child's problem behavior is not socially-maintained, - Parent does not speak English, and - Parent attendance at time of study entry is less than 80%.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
DEAL
The DEAL protocol is an Acceptance and Commitment Therapy and Behavioral Activation informed clinical protocol to undermine accommodation and help parents adhere with behavioral treatment plan components.

Locations

Country Name City State
United States Kennedy Krieger Institute Baltimore Maryland
United States Kennedy Krieger Institute Columbia Maryland

Sponsors (2)

Lead Sponsor Collaborator
Hugo W. Moser Research Institute at Kennedy Krieger, Inc. Organization for Autism Research

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Accommodation to Adherence Change Score Conditional probabilities derived from a contingency space analysis Change from Time 1 (Week 1) to Time 2 (Week 7)
Primary Experiential Avoidance The Acceptance and Action Questionnaire 2nd Edition (AAQ-II) assesses experiential avoidance (EA). The AAQ-II is a 7 item self-report instrument with a range of 7-49. Higher scores are indicative of higher levels of experiential avoidance. Change from Time 1 (Week 1) to Time 2 (Week 7)
Primary Cognitive Fusion The Cognitive Fusion Questionnaire (CFQ) assesses cognitive fusion, or rigidly following self-generated rules. The CFQ is a 7 item self-report instrument with a range of 7-49. Higher scores are indicative of a higher level of cognitive fusion. Change from Time 1 (Week 1) to Time 2 (Week 7)
Primary Parenting Stress The Parenting Stress Index - Short Form (PSI-SF) is a 36 item self-report instrument that measures parenting stress on a 5-point Likert scale. The Parental Distress subscale contains items that resemble statements that a parent might make about their own parenting skills. Self-statements oftentimes may function as rules, which we conceptualize as a more specific measure of parent cognitive fusion. Therefore, we consider high scores on this subscale to be reflective of parent-based cognitive fusion. Change from Time 1 (Week 1) to Time 2 (Week 7)
See also
  Status Clinical Trial Phase
Recruiting NCT04725721 - Testing FIRST in Youth Outpatient Psychotherapy N/A
Completed NCT03687879 - Women's Evaluation of the Childbirth Experience: From Pregnancy to Postpartum
Completed NCT03599648 - The Pro-Parenting Study: Helping Parents Reduce Behavior Problems in Preschool Children With Developmental Delay N/A
Active, not recruiting NCT03641664 - FCT Study: Reducing the Need for Out-of-Home Placements N/A
Recruiting NCT06228950 - Mindfulness-Based Intervention for Emotional and Behavioural Problems of Students With Visual Impairment N/A
Recruiting NCT05581914 - Effectiveness of the MY LIFE Treatment for Adolescents With Behavioral Problems N/A
Not yet recruiting NCT03260296 - Smartphones Addiction in Assiut University Students N/A
Completed NCT02970565 - Family Nurture Intervention, A Group Model in Connecticut N/A
Recruiting NCT05280613 - The Family Check-Up in Autism Services N/A
Recruiting NCT05603000 - Emotion Focused Family Therapy for Parents of Children With Mental Health Difficulties N/A
Completed NCT04547192 - Improving Initial Management of the Injured at Ghanaian District and Regional Hospitals With a Trauma Intake Form N/A
Completed NCT05008354 - Effect of Pyridoxine on Behavioral Adverse Events of Levetiracetam Phase 4
Completed NCT03298724 - Teachers and Parents as Partners During Middle School N/A
Completed NCT03709472 - Computer Assisted Family Intervention to Treat Self-Harm Disparities in Latinas and Sexual/Gender Minority Youth N/A
Enrolling by invitation NCT04001140 - Enhancement of Emotion Regulation Skills in Adolescents N/A
Not yet recruiting NCT06417125 - Intranasal Dexmedetomidine Versus Oral Midazolam Premedication for Postoperative Negative Behavior Changes in Children Phase 4
Active, not recruiting NCT05856435 - Tailoring CPP for the Foster Care Setting N/A
Completed NCT03694314 - Effect of Omega-3 Fatty Acids on Sleep and Behavior (Pilot Study) N/A
Recruiting NCT04298437 - Addressing Depression and Positive Parenting Techniques (ADAPT) N/A
Recruiting NCT05667675 - Targeting Child Mental Health and Household Poverty N/A