CompletedNot Applicable

Behavioral Interventions to Increase Parent Adherence With Behavior Plans

United States12 participantsStarted 2022-06-21

Plain-language 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.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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%.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Accommodation to Adherence Change Score

Timeframe: Change from Time 1 (Week 1) to Time 2 (Week 7)

Experiential Avoidance

Timeframe: Change from Time 1 (Week 1) to Time 2 (Week 7)

Cognitive Fusion

Timeframe: Change from Time 1 (Week 1) to Time 2 (Week 7)

Parenting Stress

Timeframe: Change from Time 1 (Week 1) to Time 2 (Week 7)

Trial details

NCT IDNCT05238766

SponsorHugo W. Moser Research Institute at Kennedy Krieger, Inc.

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-11-04

View on ClinicalTrials.gov More Family Accommodation trials

Plain-language summary

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Accommodation to Adherence Change Score

Timeframe: Change from Time 1 (Week 1) to Time 2 (Week 7)

Experiential Avoidance

Timeframe: Change from Time 1 (Week 1) to Time 2 (Week 7)

Cognitive Fusion

Timeframe: Change from Time 1 (Week 1) to Time 2 (Week 7)

Parenting Stress

Timeframe: Change from Time 1 (Week 1) to Time 2 (Week 7)