Does Pharmacological Treatment of Attention Deficit Hyperactivity Disorder (ADHD) in Adults Enhance Parenting Performance?
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Dyadic Parent-Child Interaction Coding System (DPICS) - Behavior Counts
研究概览
简要总结
It is now well recognized that Attention-Deficit/Hyperactivity Disorder (ADHD) is a chronic disorder of childhood that extends into adulthood for many individuals. A number of impairments in daily life functioning have been identified in adults with ADHD, including marital distress, risky driving, and using less effective parenting practices (e.g., Barkley, 2006).
Specifically, some parents with ADHD have been found to use inconsistent discipline, less parental involvement, and less positive reinforcement with their children compared to parents without ADHD (e.g., Chen & Johnston, 2007; Chronis-Tuscano, Clarke, Rooney, Diaz, & Pian, 2008). While there is some evidence that stimulant medication improves parental functioning for adults with ADHD, only one study has specifically explored the use of stimulant medication and parenting(Chronis-Tuscano, Seymour, Stine, Jones, Jiles, Rooney, et al., 2008).
The purpose of this study is to explore whether or not the stimulant medication, lisdexamfetamine, improves parent functioning. Measures of parenting behavior, parental psychosocial functioning, and child psychosocial functioning will be collected. It is hypothesized that lisdexamfetamine will be associated with some improvement in these assessments.
详细描述
Seventy families with at least one parent (either mother or father who will serve as the identified subject) and a school-aged child (ages 5-16) with ADHD will be recruited to participate in a randomized, placebo-controlled trial of lisdexamfetamine to assess the acute and prolonged effects of medication usage on parent-child interactions. The protocol will employ traditional self-report measures of parental competency and functioning used in other studies, but will supplement them with one of the most widely used observational laboratory tasks.
Families will be recruited on a rolling basis and the length of the study will be approximately 8 weeks. In the first three weeks of the study, parents will complete the dose optimization phase to find the optimal dose of lisdexamfetamine. Lisdexamfetamine will be initiated at a dose of 30mg and increased to 50mg for week 2 and 70mg for week 3. During week 4, measures of the acute effects of lisdexamfetamine will be collected, and parents will complete the observational laboratory parent child interaction tasks two times (i.e., on lisdexamfetamine and on placebo- phase I). In the remaining four weeks of the study (phase 2) a between subjects comparison will be conducted. Half of the parents will be randomized to receive lisdexamfetamine and half will receive a placebo. Measures of parent functioning will once again be collected at the end of phase 2 and parents will complete the observational laboratory task, which will allow for exploration of prolonged lisdexamfetamine treatment on parent-child interactions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parents with a diagnosis of ADHD, who also have a child with an ADHD between the ages of 5-16
排除标准
- •Parents with any of the following: any identified structural heart abnormality or other health condition that significantly affects heart performance (e.g., hypertension), a resting systolic blood pressure ≥140 and diastolic blood pressure ≥90, pregnant or breast feeding, significant psychiatric problems other than ADHD that currently require medication or any emergent psychiatric treatment, medical/psychiatric illness that could be worsened by stimulants (such as a seizure disorder, Tourette's Disorder or hyperthyroidism), or alcohol or substance abuse problems in the past 6 months.
- •Children with any of the following: any psychiatric problem other than ADHD, Oppositional Defiant Disorder (ODD), or Conduct Disorder (CD) that requires medication or any emergent psychiatric treatment, either parent or child has participated in the same parent-child interaction task used in this study in the last 6 months, either as part of a study or a clinical treatment.
研究组 & 干预措施
stimulant medication
blinded lisdexamfetamine at the optimal dose for the individual participant as previously determined during the med optimization portion of the study
干预措施: lisdexamfetamine (Drug)
placebo pill
placebo medication identical in appearance to active med
干预措施: lisdexamfetamine (Drug)
结局指标
主要结局
Dyadic Parent-Child Interaction Coding System (DPICS) - Behavior Counts
时间窗: study endpoint- end of period II (between subjects trial)
Observations of parents and children as they interact with each other during a five minute homework task and during a 10 minute non-academic task. Interactions were recorded and later coded by trained observers. Observers counted number of parent and child behaviors. Average number of behaviors per group were computed. Three subjects dropped prior to completing this assessment and one participant completed the other endpoint measures but not the DPICS, which is why the total N for this outcome is 23 at study endpoint. At end of period II (study endpoint), the medication group (n=10) was compared to the placebo group (N=13).
Dyadic Parent-Child Interaction Coding System (DPICS) - Behavior Percentages
时间窗: study endpoint- end of period II (between subjects trial)
Observations of parents and children as they interact with each other during a five minute homework task and during a 10 minute non-academic task. Interactions were recorded and later coded by trained observers. Observers counted number of parent and child behaviors. Percentages of behaviors as a function of total verbalizations (for praise, negative talk, demanding) or as a function of commands and questions (for impatient and responsive) were computed.Three subjects dropped prior to completing this assessment and one participant completed the other endpoint measures but not the DPICS, which is why the total N for this outcome is 23 at study endpoint. At end of period II (study endpoint), the medication group (n=10) was compared to the placebo group (N=13).
次要结局
- Alabama Parenting Questionnaire (APQ)(study endpoint- end of period II (between subjects trial))
- Disruptive Behavior Disorders Rating Scale (DBD)(baseline and week 4)
- Impairment Rating Scale (IRS)(study endpoint- end of period II (between subjects trial))
- Sheehan Disability Scale (SDS)(study endpoint- end of period II (between subjects trial))
- Dyadic Parent-Child Interaction Coding System (DPICS)(weeks 4 and weeks 5 (period I within subjects trial))
- Dyadic Parent-Child Interaction Coding System (DPICS) - Behavior Percentages(weeks 4 and weeks 5 (period I within subjects trial))
- Pittsburgh Side Effect Rating Scale(baseline and end of dose optimization phase/week 4)
- Adult ADHD Rating Scale (ADHD RS)(study endpoint- end of period II (between subjects trial))
- Parenting Stress Index (PSI)--Total Stress(study endpoint- end of period II (between subjects trial))
- Parenting Locus of Control (PLC)(study endpoint- end of period II (between subjects trial))
- Brown Attention Deficit Scale (BAADS)(study endpoint- end of period II (between subjects trial))
- Social Skills Rating System (SSRS)(study endpoint- end of period II (between subjects trial))
- Disruptive Behavior Disorder Rating Scale (DBD)(study endpoint- end of period II (between subjects trial))
- ADHD Severity Clinical Global Impressions Severity Subscale(study endpoint- end of period II (between subjects trial))
- Barkley Home Situations Questionnaire (HSQ)(study endpoint- end of period II (between subjects trial))
- Pittsburgh Side Effect Rating Scale Mean Severity Rating.(study endpoint- end of period II (between subjects trial))
- Resting Blood Pressure(study endpoint- end of period II (between subjects trial))
- Weight(study endpoint- end of period II (between subjects trial))
- Resting Pulse(study endpoint- end of period II (between subjects trial))
- Pittsburgh Side Effects Rating Scale - Percent Present for All Reported Adverse Events Occurring at a Rate of 5% or More(end of medication optimization phase/week 4)
- Adult ADHD Rating Scale Completed at the End of the Med Optimization Phase(baseline and end of med optimization phase/week 4)