Effectiveness of Child-Parent Relationship Therapy (CPRT)

Sponsor

Fatima Jinnah Women University (Other)

Overall Status

Recruiting

CT.gov ID

NCT06087302

Collaborator

(none)

Enrollment

Location

Arms

9.3

Anticipated Duration (Months)

9.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Exposure to trauma during childhood contributes to behavioral and attachment difficulties in children. The current research study will be conducted on the effectiveness of child-parent relationship therapy (CPRT) on psychological distress and family functioning among parents of children exposed to trauma. The CPRT is an evidence-based intervention parenting program that gives training to the parents, to help children who have social, emotional, attachment, and behavioral difficulties. A CPRT would train parents with the principles of CCPT and provide them with the ability to support their children. A randomized controlled trial will validate the effect of CPRT on family functioning, and parental psychological distress among parents of children exposed to trauma. It will be an interventional-based study on CPRT with a pre-posttest experimental design. The current study would be conducted in Islamabad and Rawalpindi, after obtaining permission from the appropriate authorities, for collecting data from the educated mothers/caretakers as a research sample. There would be inclusive and exclusive selection criteria for the sample. A study will be conducted in four ways, firstly, the need assessment will be conducted with phenomenological research design from selected educated mothers/caretakers on the KAP model (knowledge, attitudes, and practices) categories about the CPRT, and psychological distress on family functioning among parents of children exposed to trauma. In phase two, the pilot study will be conducted to assess the accuracy of measures for the sample and the effectiveness of CPRT. In phase three, a cross-sectional survey would measure the study variables. The fourth phase will be the intervention phase for validation of CPRT therapeutic techniques in the Pakistani population a randomized controlled trial design will be applied to analyze the effect of CPRT on study variables in the next phase (main study). The measures Child-Parent Relationship Scale, depression, anxiety, and stress scale, family assessment device, and disruptive behavior through Eyberg child behavior inventory (ECBI) parental-version will be used to collection the data from study participants. The Child and Adolescent Trauma Screen and the child trauma screen would be used as a screening inventory. The CPRT intervention therapeutic sessions will continue based on the inclusive and exclusive selection criteria. The data will be evaluated through SPSS (latest version).

Condition or Disease	Intervention/Treatment	Phase
Behavior Disorders in Children	Behavioral: child-Parent Relationship Therapy (CPRT)	N/A

Detailed Description

Nature of Study The proposed study is primary in nature. A primary data collection is intended for the current study, which would gather information from parents of children exposed to trauma Study Design The proposed research design, the current study would be centered on a mixed research design to measure study objectives. The objectives are based on the exploratory qualitative design and cross-sectional experimental research design. The study would adopt the mixed methodology (exploratory research design, cross-sectional research design) and randomized controlled experimental method (in terms of pre and post-intervention effects).

The child-parent relationship (in the context of closeness and conflict) would predict the primary outcome of family functioning (in the context of Warmth, Communication, Support conflicts, and worries) and psychological distress (in the context of depression, anxiety, stress). The secondary outcome would be the child's behavior ( in the context of internalized symptoms of Grief/ Loss and anxiety/Mood). Child Parent-relationship therapy would be used for implementation to study the level of family functioning and psychological distress. CPRT will introduce special play time to the parent for the children exposed to trauma and will study the level of internalized symptoms of the child's behavior. The current study would find out the effectiveness of CPRT on child-parent relationships, parental psychological distress in family functioning, and parents of children exposed to trauma in twin cities of Pakistan.

During phase one, the exploratory research design will be used to collect the data from the selected sample on knowledge, attitudes, and practices categories about the parent-child relationship, and psychological distress on family functioning among parents of children exposed to trauma. During phase two, a cross-sectional survey will be conducted to see the association between the study variables and differences between the demographic characteristics of the sample.

During phase three Randomized controlled trial (RCT), will be used for: a) Mean scores validation of Child-parent relationship therapeutic techniques in the Pakistani family functioning. b) The parents of children exposed to trauma who receive intensive child-parent relationship training attain a comparison of level of psychological distress mean scores of DASS between the group compared with non-treatment comparison group parents of children exposed to trauma c) The Comparison between the mean scores of the Eyberg child behavior inventory parental version of children's disruptive behavior and significant difference between the pre-testing and post-testing. d) comparison between within a group mean scores of child-parent relationship scale in post-testing. e) Differences in mean scores between the experimental group's pre- and post-testing results and, f) Statistical mean score based on post-testing assessment results, statistical mean score differences will be evaluated between experimental and control groups.

Sample Research participants would be selected initially with snowball sampling techniques and later with purposive sampling. Research participants would be recruited including educated mothers (minimum qualification would be graduation 14 years of qualification) from twin cities (Rawalpindi and Islamabad) of Pakistan. The demographic characteristics of the sample would be, family system ( joint family, and nuclear family system) , marital status( married, widow, separated/divorced), and monthly income and age. Additional inclusive sample criteria also include the parents of children exposed to traumatic experiences, child abuse, bullying, fighting, accidents, traumatized grief, and parents' separation. Exclusive Sample criteria will not include uneducated parents, domestic violence child sexual abuse, natural disasters, traumatic events that caused physical disabilities, war, terrorism victims, and families who would be taking any psychotherapy or training for the management of psychological distress and child disruptive behavior. Each potential parent would be screened briefly through screening inventories for all phases of the current study. Before every interview, the researcher would be clear the objectives of the current study. The ethical considerations would be considered for selected research participants for all phases.

Phase-I research participants would be fifteen to twenty-five educated mothers' target. The data will be collected through semi-structured interviews till the time of saturation. Phase-II research participants would be calculated through Raosoft. Phase III there would be n=x research participants finalized for the experimental group after the screening and would meet the inclusion criteria. The experimental group would be divided into 8 groups. There would be 8 research participants in each group as the requirement of the CPRT protocol. A randomization process ensures that all research participants have the same demographic characteristics in intervention and control groups. The children's age should be between 3-10 years as it is a basic criterion of child-parent relationships. The pre-testing session would be conducted before the intervention phase. The post-testing session would be conducted after the intervention phase.

Scientifically, the sample size should be chosen according to the study design. The decision on research sample size is crucial and experts recommended the suggestions, the sufficient sample size required for experimental and causal -comparative research studies should be more than 50 participants. Furthermore, the sample size of 100 participants for each subgroup in survey studies is in the case of the general population but a 2-50 sample is sufficient in the case of the rare subgroup (Guetterman, 2020). Moreover, existing literature says, that for the parametric tests a sample of 30-500 participants should be taken in the study.

Furthermore, it is not always possible to meet randomization requirements in educational research studies, thus an extensive reliance on numbers may not be an adequate representation. Available resources, time constraints, and the number of volunteers that would be willing to participate in a study govern sample size in research, especially in educational research. Therefore, approximately 30-60 parents of children exposed to trauma would be randomly split into interventional and control groups after initial assessment.

Measures According to all phases of the current study, different measurements will be used to meet the objectives. A study will be conducted in three ways, firstly, the need assessment will be conducted with exploratory research design from selected educated mothers/caretakers on knowledge, attitudes, and practices categories about the relationship between parents and children, psychological stress, family functioning of parents of traumatized children experiences psychological distress. For need assessment, therefore semi-structured interview protocol will be developed according to the categories identified from the literature. In phase two, a correlational survey will be conducted to see the relationship between the study variables. For validation of CPRT therapeutic techniques in the Pakistani population, a randomized controlled trial design will be used to examine the impact of CPRT on study variables in the next phase (main study). The measures of the Child-Parent Relationship Scale, depression, anxiety, stress scale, family assessment device, The child and adolescence Trauma Screen and the child trauma screen (CTS) and for disruptive behavior through the Eyberg Child Behavior Inventory parental version.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

85 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Intervention Model Description:

Child-Parent Relationship Therapy (CPRT) is a play-established therapy process for young children, aged between 3-10, who have attachment issues, and behavioral, social, or emotional issues. It is based on ten weekly, two-hour group sessions for a group of 5-8 members in the group. Learning skills, receiving feedback on skill practice, and connecting with other parents for support are all critical components of the CPRT program. Parents learn skills and prepare for future play sessions with their children during sessions 1-3. Parents practice their new skills with their children in weeks 4-10, while the therapist provides feedback in a small group setting.Child-Parent Relationship Therapy (CPRT) is a play-established therapy process for young children, aged between 3-10, who have attachment issues, and behavioral, social, or emotional issues. It is based on ten weekly, two-hour group sessions for a group of 5-8 members in the group. Learning skills, receiving feedback on skill practice, and connecting with other parents for support are all critical components of the CPRT program. Parents learn skills and prepare for future play sessions with their children during sessions 1-3. Parents practice their new skills with their children in weeks 4-10, while the therapist provides feedback in a small group setting.

Masking:

Double (Participant, Care Provider)

Masking Description:

there would be two groups intervention group and a control group.

Primary Purpose:

Other

Official Title:

Effectiveness of Child-Parent Relationship Therapy (CPRT) for Management of Psychological Distress and Family Functioning Among Parents of Children Exposed to Trauma

Actual Study Start Date :

May 23, 2023

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Feb 29, 2024

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: control group the control group wouldnot receive the CPRT for caregivers/parents
Experimental: CPRT intervention group intervention group would receive the CPRT for caregivers/parents	Behavioral: child-Parent Relationship Therapy (CPRT) The Child Parent Relationship Therapy (CPRT) is an evidence-based intervention program that trains parents/caretakers to help their children with social, emotional, attachment, and behavioral difficulties

Arm

Intervention/Treatment

No Intervention: control group

the control group wouldnot receive the CPRT for caregivers/parents

Experimental: CPRT intervention group

intervention group would receive the CPRT for caregivers/parents

Behavioral: child-Parent Relationship Therapy (CPRT)

The Child Parent Relationship Therapy (CPRT) is an evidence-based intervention program that trains parents/caretakers to help their children with social, emotional, attachment, and behavioral difficulties

Outcome Measures

Primary Outcome Measures

CPRS [10-15 min]
The CPRS consists of fifteen items about the child and the parent's relationship with it. Likert weighed the fifteen items on a 5-point scale, and CPRS can be summarized by groups of objects that most closely correspond to the discrepancy and closeness.
DASS-42 [5-10 min]
it is based on measurements rather than categorical concepts of mental distress, and scores emphasize symptoms are experienced, not diagnostic thresholds. it has been unable to use a child's scale for 12 years, The three symptom clusters are as follows: Depression: Illegal problems, despair, life assessment, vertical, pride, interest/involvement, and tribe/involvement, Anxiety: Herbal arousal, skeletal muscle effects, conditional warnings, fear of anxiety. Stress: Chronic non-special Here, the complexity is comfortable, nervous, easily frustrated/excited, sensitive/impatient beyond.
FAD [10-15 min]
measures structural, organizational, and transactional factors within families. A total of six scales are used to measure the six dimensions of the MMFF - affective involvement, affective responsiveness, behavioral control, communication, problem solving, and roles - as well as a seventh measure measuring general family functioning

Secondary Outcome Measures

ECBI [5-10 min]
is a widely used assessment tool designed to evaluate disruptive behaviors in children. Specifically, the Parental Version of the ECBI is a questionnaire completed by parents or caregivers to provide information about a child's behavior.There are 36 items

Other Outcome Measures

CTS [5-10 min]
10 questions cover various domains, including physical abuse, sexual abuse, witnessing violence, accidents, natural disasters, and other types of traumatic incidents. It focuses on capturing both traumatic events and the child's emotional and behavioral responses to those events. It aims to identify symptoms and reactions commonly associated with trauma. These symptoms include intrusive thoughts, nightmares, avoidance behaviors, hypervigilance, changes in mood or behavior, and difficulties with sleep or concentration. age 6-17 years
CAT-C [5-10 min]
The questionnaire is indeed a screening tool designed to assess potentially traumatic events and posttraumatic stress symptoms (PTSS) in children and adolescents. It is based on the DSM-5 criteria for PTSD. The CATS questionnaire typically consists of questions related to traumatic events and symptoms associated with PTSD. According to the DSM-5, (2013) the CATS measures potentially traumatic experiences and posttraumatic stress symptoms (PTSS). age 3-17 y

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 55 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

qualification would be graduation minimum and above
location: from Pakistan's twin cities (Rawalpindi and Islamabad). 3. the parents of children exposed to traumatic experiences I) child abuse (physical abuse, yelling, Psychological Abuse) ii) bullying, ( witness of bullying, verbal bullying, physical bullying) iii) fighting, (street fighting. withness of fighting) iv) accidents, v) traumatized grief, (death of a loved one) vi) Robbery and vii) parents' separation. -

Exclusion Criteria: Exclusive Sample criteria I) uneducated parents, (less then graduation ) ii) domestic violence iii) child sexual abuse, iv) natural disasters, v) traumatic events that caused physical disabilities, vi) war, vii) terrorism victims, and viii) families who would be taking any psychotherapy or training to manage psychological distress and child disruptive behavior.