Treatment for Problematic Sexual Behavior of Preteen Children
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Change in scores on the Child Sexual Behavior Inventory (CSBI)
研究概览
简要总结
Relatively little is known about the treatment of problematic sexual behavior (PSB) displayed by preteen children. Randomized controlled trials (RCTs) examining potential treatments are rare and the available results to date are generally underwhelming. A new protocol, termed Phase-Based Treatment (PBT) for Preteen PSB, has shown positive results in an early stage pilot and during community implementation efforts. This trial will be the first RCT of PBT and aim to determine whether PBT might outperform a treatment-as-usual condition.
详细描述
In 2015, a new intervention, PBT, was designed that relied on the current etiological research on PSB and the state-of-the-science regarding behavior change among children. A small pilot of the protocol yielded positive results. Although the pilot included only 10 participants, statistically significant pre-post changes were observed for general PSB, intrusive forms of sexual behavior, and social modeling of sexuality in the home. Training in PBT was provided to a limited number of practicing clinicians in the state of Texas and program evaluation metrics were included. Pre-post change for general PSB was significant, as were changes for intrusive forms of sexual behavior.
Despite positive outcomes in non-controlled research, it is unclear whether PBT achieves effects larger than might be seen with more general, non-specific forms of intervention. To demonstrate such an effect requires the completion of a randomized controlled trial (RCT). However, a number of feasibility issues must be answered before conducting a large scale, definitive RCT. As such, the current RCT is conceived as a feasibility project to determine the likelihood of successfully recruiting and retaining a sufficient number of participants, to derive comparative effect size estimates between PBT and SAU to inform later power analyses, and to ascertain participant satisfaction with PBT.
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)
盲法说明
Participants will be unaware of whether they are assigned to the experimental or control condition. Research assistants collecting data will similarly be unaware of the participant's condition during assessment.
入排标准
- 年龄范围
- 4 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child between ages 4 and 12 years
- •Caregiver reports a raw score on the CSBI greater than
- •A primary caregiver is willing to participate in treatment.
- •Child earns a scaled score above 69 on the Kaufman Brief Intelligence Test (KBIT-2)
- •Child proficient in spoken English
- •Caregiver proficient in written and spoken English.
排除标准
- •Child is less than 4 years of age or older than 12 years of age.
- •Caregiver reports a score on the CSBI lower than 4
- •A primary caregiver is unwilling to participate in treatment.
- •Child scored lower than 70 on the KBIT-
- •The primary caregiver is suspected of perpetrating child sexual abuse.
- •Child not proficient in spoken English.
- •Caregiver not proficient in both written and spoken English.
研究组 & 干预措施
Experimental Treatment
The experimental treatment is Phase-Based Treatment (PBT) for Problematic Sexual Behavior of Preteen Children, an innovative intervention demonstrating promise in preliminary testing.
干预措施: Phase-based Treatment (PBT) for Problematic Sexual Behavior of Preteen Children (Behavioral)
Control Treatment
The Control Treatment will utilize a Treatment-as-Usual (TAU) condition designed to mimic the types of treatment generally provided in the community for mental health concerns of children.
干预措施: Treatment-as-Usual (TAU) (Behavioral)
结局指标
主要结局
Change in scores on the Child Sexual Behavior Inventory (CSBI)
时间窗: Through study completion, typically 12 weeks.
The CSBI is a widely-used measure of problematic sexual behavior among preteen children. It is completed by caregivers and asks the frequency with which 38 different items were observed over the past six months. Caregivers report frequency using a 4-point Likert-type scale ranging from 0 (Not at all) to 3 (at least once per week).
次要结局
- Change in scores on the Sexual Concerns subscale of the Trauma Symptom Checklist for Young Children (TSCYC)(Through study completion, typically 12 weeks.)
- Change in scores on the Family Sexuality Index (FSI).(Through study completion, typically 12 weeks.)
- Change in scores on the Conduct Problems subscale of the Strengths and Difficulties Questionnaire (SDQ)(Through study completion, typically 12 weeks.)
研究者
Brian Allen, Psy.D.
Associate Professor of Pediatrics
Milton S. Hershey Medical Center